RedHill's RHB-204 Demonstrates Comparable MAP Killing Efficacy to RHB-104 - Important Step in RHB-204 Development for MAP-related Crohn's Disease

Rhea-AI Summary

RedHill (CPIX) reported in vitro data showing its next-generation oral candidate RHB-204 demonstrates MAP killing comparable to RHB-104, achieved in spot and phage assays and using lower doses of two active ingredients. A Phase 2 trial in MAP-positive Crohn's disease patients is planned, with non-dilutive funding sought and multiple regulatory designations and patent protection through 2041.

AI-generated analysis. Not financial advice.

Positive

• In vitro MAP killing comparable to RHB-104 in spot and phage assays
• Comparable efficacy achieved with lower doses of two active ingredients
• Planned Phase 2 focused on a defined MAP-positive Crohn's disease population
• RHB-104 Phase 3 previously showed clinical remission: 36.7% vs 22.4% (64% relative improvement)
• Patent protection through 2041 and multiple regulatory designations (Fast Track, Orphan, QIDP)

Negative

• RHB-204 comparability shown only in vitro; clinical efficacy in humans not yet demonstrated
• Planned Phase 2 depends on successful MAP detection and non-dilutive funding
• MAP detection is slow and historically difficult, posing trial enrollment and diagnostic risks
• Regulatory benefits cited (breakthrough, priority review) are potential, not guaranteed

News Market Reaction – CPIX

-0.48%

1 alert

-0.48% News Effect

On the day this news was published, CPIX declined 0.48%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Efficacy improvement: 64% more effective P-value: p = 0.0048 Phase 3 sample size: 331 patients +5 more

8 metrics

Efficacy improvement 64% more effective RHB-104 plus SoC vs SoC alone in Crohn’s disease Phase 3

P-value p = 0.0048 Primary endpoint of induction of clinical remission at week 26

Phase 3 sample size 331 patients Randomized, double-blind, placebo-controlled CD Phase 3 study of RHB-104

Remission rate RHB-104 36.7% CD remission at week 26 in RHB-104–treated group

Remission rate placebo 22.4% CD remission at week 26 in placebo (SoC only) group

Non-responders to anti-TNF Up to 40% CD patients failing to respond to anti-TNF treatment

CD market 2024 $13.6 billion Crohn’s disease market size in 2024 in key markets

CD market 2033 $19.1 billion Projected Crohn’s market size in 2033; CAGR 3.87%

Market Reality Check

Price: $4.57 Vol: Volume 232,956 is 0.08x t...

low vol

$4.57 Last Close

Volume Volume 232,956 is 0.08x the 20-day average of 2,800,873, indicating limited pre-news activity. low

Technical Shares trade above the 200-day MA at 3.38, with a pre-news price of 4.21.

Peers on Argus

The stock was down 1.64% while key peers like DRRX, ASRT, CRDL and INCR also sho...

The stock was down 1.64% while key peers like DRRX, ASRT, CRDL and INCR also showed declines, but none appeared in the momentum scanner and sector momentum was not flagged, suggesting a stock-specific move rather than a broad sector rotation.

Historical Context

5 past events · Latest: Apr 28 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Apr 28	Earnings call timing	Neutral	-1.6%	Announcement of Q1 2026 results release and conference call schedule.
Apr 27	Full-year results	Positive	+3.2%	Full-year 2025 results with strategic deals, cash position and legal win.
Apr 23	Business sale deal	Positive	+27.9%	Agreement to sell U.S. branded business to Apotex affiliate for $100M cash.
Apr 22	Preclinical oncology data	Positive	-2.3%	Opaganib preclinical data enhancing chemo and STING-mediated immunity.
Apr 16	Label expansion	Positive	-3.4%	FDA approval expanding Caldolor injection indication and website launch.

Pattern Detected

Positive clinical or strategic news has sometimes aligned with strong gains, but several favorable regulatory or R&D updates saw negative next-day moves, indicating mixed follow-through on good news.

Recent Company History

Over recent months, the company’s news flow included a planned Q1 2026 results release, a major $100 million divestiture of U.S. branded assets, and regulatory expansion for Caldolor. Positive strategic transactions drove a strong 27.87% move, while favorable regulatory and pipeline updates at times coincided with declines of 2–3%. The current MAP‑focused Crohn’s data add to this pattern of clinically meaningful announcements set against uneven short-term price reactions.

Market Pulse Summary

This announcement highlights new in vitro data showing RHB‑204’s MAP killing efficacy comparable to ...

Analysis

This announcement highlights new in vitro data showing RHB‑204’s MAP killing efficacy comparable to RHB‑104, backed by a 331‑patient Phase 3 dataset and a growing Crohn’s market projected from $13.6B to $19.1B. The news fits within a series of clinical and strategic updates that have produced mixed short‑term price reactions. Investors may watch future clinical milestones, regulatory interactions, and partnering or funding developments as key markers of how this program progresses.

Key Terms

mycobacterium avium subspecies paratuberculosis, phase 3, phase 2, anti-tnf, +4 more

8 terms

mycobacterium avium subspecies paratuberculosis medical

"new in vitro testing results demonstrating RHB-204's comparability to RHB-104 in Mycobacterium avium subspecies paratuberculosis (MAP) killing"

Mycobacterium avium subspecies paratuberculosis (MAP) is a slow-growing bacterial pathogen that infects the intestines of ruminant animals, causing chronic wasting and reduced milk or meat production; it behaves like a hidden leak in a herd, building damage over years before obvious signs appear. Investors should care because MAP can lower livestock productivity, trigger testing, culling, trade restrictions or food-safety scrutiny, and drive demand for diagnostics, vaccines and regulatory compliance — all of which affect agricultural revenues and supply chains.

phase 3 medical

"In its positive Phase 3 study, RHB-104 met the primary and key secondary endpoints"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

phase 2 medical

"RedHill's novel Phase 2 RHB-204 study is designed to be the first-ever adequately controlled clinical study"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

anti-tnf medical

"Up to 40% of CD patients fail to respond to anti-TNF treatment"

Anti-TNF are drugs that block a specific immune signal called tumor necrosis factor (TNF) which can drive inflammation in conditions like rheumatoid arthritis and inflammatory bowel disease; think of them as turning down a stuck ‘alarm’ in the immune system. Investors care because these medicines are high-value prescription drugs with large patient populations, patent and biosimilar competition, and clinical trial or regulatory news that can quickly change a company’s revenue outlook.

orphan drug designation regulatory

"Expected transferal of RHB-104's FDA pediatric orphan drug designation to RHB-204"

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

fast track designation regulatory

"potential for breakthrough therapy designation, fast track designation, additional regulatory exclusivity"

A "fast track designation" is a process that speeds up the review and approval of a product or project, allowing it to reach the market or be completed more quickly than usual. For investors, it can signal that a product may become available sooner, potentially leading to earlier revenue or benefits, and indicating a priority status that might influence company performance and market opportunities.

qidp designation regulatory

"RHB-204 is patent protected through 2041, granted FDA Fast Track and Orphan Drug Designation, QIDP Designation under the GAIN Act"

A QIDP designation is a regulatory label given to a new drug or biologic that targets serious or life‑threatening bacterial or fungal infections. It matters to investors because the designation brings tangible incentives—faster review, a priority pathway through regulators, and extra time with reduced competition after approval—similar to giving a product a VIP fast‑lane plus a longer exclusive sales window, which can boost potential returns and reduce development risk.

double-blind, placebo-controlled medical

"randomized, double-blind, placebo-controlled 331-patient Phase 3 study of RHB-104 in active CD"

A clinical trial design in which participants are randomly assigned to receive either the experimental treatment or an inactive substitute (a placebo), and neither the participants nor the researchers know who is receiving which. This setup limits bias and makes it far easier to tell whether a drug or intervention truly works, similar to a blind taste test, so results carry more weight for regulatory decisions and for investors assessing a product’s commercial prospects.

AI-generated analysis. Not financial advice.

RHB-204¹ is a next-generation optimized formulation of RedHill's oral RHB-104², designed for enhanced tolerability, safety profile and patient adherence, that employs a groundbreaking Mycobacterium avium subspecies paratuberculosis (MAP)-targeted therapeutic approach for Crohn's disease (CD)

In its positive Phase 3 study, RHB-104 met the primary and key secondary endpoints with statistical significance, showing RHB-104 plus standard of care (SoC) to be 64% more effective than SoC alone, in treating CD compared to the placebo (standard of care only) group (p = 0.0048)³

New RHB-204 in vitro data, from both spot and phage assays, demonstrated comparable MAP killing to RHB-104⁴. Importantly, MAP killing efficacy was achieved with lower doses of two of the active ingredients compared to RHB-104, indicative of potential for reduced toxicity and side effects

Based on the FDA guidance on path to approval, RedHill's novel Phase 2 RHB-204 study is designed to be the first-ever adequately controlled clinical study in a specifically defined MAP-positive CD patient population - a potentially paradigm changing approach to treatment of Crohn's disease. With discussions ongoing and grant application submitted, funding for this program is planned to be non-dilutive 

Expected transferal of RHB-104's FDA pediatric orphan drug designation to RHB-204, potential for breakthrough therapy designation, fast track designation, additional regulatory exclusivity and priority review voucher. RHB-204 is patent protected through 2041, granted FDA Fast Track and Orphan Drug Designation, QIDP Designation under the GAIN Act (extending US market exclusivity to a potential total of 12 years) and EU Orphan Designation (eligibility for 10 years EU market exclusivity) for NTM disease caused by MAC⁵

The multibillion-dollar CD market is expected to grow from $13.6 billion in 2024 to over $19 billion in 2033 in key markets,⁶ presenting a significant opportunity for new FDA-approved therapies

RALEIGH, N.C. and TEL AVIV, Israel, April 30, 2026 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced new in vitro testing results demonstrating RHB-204's comparability to RHB-104 in Mycobacterium avium subspecies paratuberculosis (MAP) killing efficacy. Oral RHB-204 is a next-generation optimized formulation of RedHill's RHB-104, designed for enhanced tolerability, safety profile and patient adherence, that employs a groundbreaking MAP-targeted therapeutic approach to the treatment of Crohn's disease (CD).

The comparability results were achieved in both spot and phage assays of several different MAP strains. Importantly, the MAP killing efficacy was achieved with lower doses of two of the active ingredients compared to RHB-104, indicative of the potential for reduced toxicity and side effects.

"As published in the peer-reviewed journal, Antibiotics³, RedHill's RHB-104 had previously delivered positive Phase 3 results showing a statistically significant 64% improvement in efficacy in treating CD using this potentially transformative MAP-targeted approach, achieving the primary endpoint of induction of clinical remission at week 26 (p = 0.0048). The demonstration of RHB-204's comparability to RHB-104 is an important step forward in the ongoing development of RHB-204 for MAP-related CD, following the pathway to approval guided by the FDA at our positive meeting," said Reza Fathi, PhD, Senior VP, R&D at RedHill. "Up to 40% of CD patients fail to respond to anti-TNF treatment, and over time a similar number of responders lose response and have disease flare-ups⁷. Many existing treatment options are both expensive and intravenously administered, further increasing the cost burden. Moreover, several of these existing therapies have known safety issues, including Black Box Warnings. A safe and effective orally administered therapy would provide a welcome alternative approach."

A planned Phase 2 study of RHB-204 in CD is expected to be the first clinical study in a specifically defined MAP-positive CD patient population. There is a significant body of peer reviewed published research supporting the scientific rationale that MAP may be a root cause of CD⁸, however, a major hurdle in previous clinical studies for new therapies directed at MAP has been the ability to rapidly and accurately detect MAP – one of the slowest growing and hard to detect bacteria on the planet. This study, along with RedHill's collaborations with two leading European academic centers for the provision of cutting-edge MAP detection diagnostics, which support the study's novel design and the potential future commercial application of RHB-204, represents a groundbreaking approach that could potentially make RHB-204, if approved, an exciting new therapy treating both the suspected cause of the disease and its symptoms.

RedHill is actively pursuing partnerships and collaborations for this program, including via an innovation development grant application, which has already been submitted. In addition, RedHill is engaging in ongoing discussions with non-dilutive external funding sources.

The development of RHB-204 is supported by a strong foundation of published clinical efficacy and safety data from the randomized, double-blind, placebo-controlled 331-patient Phase 3 study of RHB-104 in active CD, which successfully met its primary and secondary endpoints, showing RHB-104 plus standard of care (SoC) to be 64% more effective than SoC alone, achieving clinical CD remission at week 26 (the primary endpoint) in 36.7% of the RHB-104-treated group compared to 22.4% in the placebo (standard of care only) group³. The Phase 3 study also demonstrated the safety and efficacy of concomitant use of RHB-104 with anti-TNFs, immunomodulators and steroids, suggesting that RHB-204 could be a transformative safe and effective, stand-alone or combination, oral therapy³.

The CD market is expected to expand significantly through 2033, with sales in the United States, Japan, and five major European markets, growing from $13.6 billion to $19.1 billion at a compound annual growth rate (CAGR) of 3.87%⁵.

About RHB-204

RHB-204 is a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin and clofazimine, at specific doses designed to safely and effectively treat Mycobacterium avium subspecies paratuberculosis-positive (MAP-positive)-related Crohn's disease.

Patent protected until at least 2041, and with an expected pediatric orphan designation (subject to the U.S. Food and Drug Administration (FDA) approval to transfer from RHB-104), RHB-204 is a next-generation formulation of RHB-104 with an optimized formulation for the treatment of CD. It contains the same three antimicrobial agents with potent intracellular, anti-mycobacterial and anti-inflammatory properties, and with an optimized dosing profile, RHB-204 provides the potential for enhanced tolerability, safety and compliance with a 40% pill burden reduction. RHB-204 is supported by a strong foundation of clinical data from the positive safety and efficacy results achieved in the Phase 3 study of RHB-104 in CD, with its potential further demonstrated using mucosal healing imaging, considered to be the gold standard for efficacy evaluation in CD.

Originally developed for the treatment of pulmonary non-tuberculous mycobacteria (NTM) disease caused by Mycobacterium avium complex (MAC), RHB-204 was granted FDA Fast Track and Orphan Drug Designation, in addition to QIDP Designation under the Generating Antibiotic Incentives Now Act (GAIN Act), extending U.S. post-approval U.S. market exclusivity to a potential total of 12 years. RHB-204 has additionally been granted EU Orphan Designation, providing eligibility for 10 years EU post-approval market exclusivity. Where applicable, the Company intends to explore the potential for additional regulatory process designations, such as breakthrough therapy designation and fast track designations that may provide additional exclusivity or potential for priority review vouchers.

About Crohn's Disease

Crohn's disease (CD) is a form of Inflammatory Bowel Disease (IBD) causing inflammation of digestive tract tissue that can lead to abdominal pain, severe diarrhea, fatigue, weight loss and malnutrition. CD can be highly debilitating and remains a serious burden for both patients and healthcare systems: destroying quality of life and even leading to life-threatening complications. There is no known cure for Crohn's disease. It is estimated that 1 million Americans⁹ and approximately 6-8 million people globally have Crohn's disease¹⁰.

Commonly used FDA-approved therapies in the treatment of CD include: Abbvie's Humira® (adalimumab), Janssen's Remicade® (infliximab) and Stelara® (Ustekinumab), BMS's Zeposia® (ozanimod) and Pfizer's Xeljanz® (tofacitinib).

About RedHill Biopharma

RedHill Biopharma Ltd. (NASDAQ: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA-approved gastrointestinal drug Talicia, for the treatment of Helicobacter pylori (H. pylori) infection in adults¹¹, with a U.S. co-commercialization agreement with Cumberland Pharmaceuticals (NASDAQ: CPIX). RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anti-inflammatory, antiviral, metabolic and anticancer activity, targeting multiple indications with U.S. government and academic collaborations for development for medical countermeasures including radiation and chemical exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and an ongoing Phase 2 study in prostate cancer in combination with darolutamide; (ii) RHB-102 (Bekinda), with a planned Phase 2 proof-of-concept study for GLP-1/GIP receptor agonist-associated GI intolerance, positive results from a U.S. Phase 3 study for acute gastroenteritis and gastritis, positive results from a U.S. Phase 2 study for IBS-D and potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting. RHB-102 is partnered with Hyloris Pharmaceuticals (EBR: HYL) for worldwide development and commercialization outside North America; (iii) RHB-204, a next-generation optimized formulation of RHB-104, with a planned Phase 2 study for Crohn's disease (based on RHB-104's positive Phase 3 Crohn's disease study results); and (iv) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, including COVID-19 and also targeting multiple cancer and inflammatory gastrointestinal diseases.

Visit www.redhillbio.com / X.com/RedHillBio for more information about the Company

Forward Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words, and include, among others, statements regarding the potential transferal of pediatric orphan drug designation to RHB-204, the potential for breakthrough therapy designations, fast track designations, additional regulatory exclusivity and priority review vouchers, the potential for partnerships and funding sources for the development of RHB-204, and the potential success of any transactions, commercial programs or development activities. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: the risk that development of RHB-204 for Crohn's disease may not be completed, or if completed may not be approved or may not achieve commercial success; the risk that opaganib is not effective against the indications for which we develop our products; the risk that RHB-102 (Bekinda) does not effectively reduce GLP-1/GIP-related nausea, vomiting and diarrhea; the risk regarding the Company's ability to regain and maintain compliance with Nasdaq's listing requirements, including the minimum bid price requirement; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that the Company will not receive future milestone payments under its existing agreements or that they will be less than anticipated; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that the Company's development programs and studies may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional studies may be required; the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of any necessary commercial companion diagnostics; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia; (v) the Company's ability to successfully commercialize and promote Talicia; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) the Company's ability to collect on its judgement against Kukbo; (xiii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiv) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xv) competition from other companies and technologies within the Company's industry; and (xvi) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 27, 2026. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

Company contact:

Adi Frish
Chief Corporate and Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com 

Category: R&D

¹ RHB-204 is an investigational new drug, not available for commercial distribution in the United States.
² RHB-104 is an investigational new drug, not available for commercial distribution in the United States.
³ Graham DY, et al. Randomized, Double-Blind, Placebo-Controlled Study of Anti-Mycobacterial Therapy (RHB-104) in Active Crohn's Disease. Antibiotics (Basel). 2024 Jul 25;13(8):694. doi: 10.3390/antibiotics13080694. PMID: 39199994; PMCID: PMC11350828.
⁴ Data on file
⁵ Non-tuberculous mycobacteria (NTM) lung disease caused by Mycobacterium avium complex (MAC)
⁶ DataMonitor - Disease Analysis: Crohn's Disease, September 2024
⁷ Singh S, George J, Boland BS, Vande Casteele N, Sandborn WJ. Primary Non-Response to Tumor Necrosis Factor Antagonists is Associated with Inferior Response to Second-line Biologics in Patients with Inflammatory Bowel Diseases: A Systematic Review and Meta-analysis. J Crohns Colitis. 2018 May 25;12(6):635-643. doi: 10.1093/ecco-jcc/jjy004. PMID: 29370397; PMCID: PMC7189966.
⁸ Bull T.J., McMinn E.J., Sidi-Boumedine K., Skull A., Durkin D., Neild P., Rhodes G., Pickup R., Hermon-Taylor J. Detection and verification of Mycobacterium avium subsp. paratuberculosis in fresh ileocolonic mucosal biopsy specimens from individuals with and without Crohn's disease. J. Clin. Microbiol. 2003;41:2915–2923. doi: 10.1128/JCM.41.7.2915-2923.2003
⁹ Lewis JD, Parlett LE, Jonsson Funk ML, et al. Incidence, prevalence, and racial and ethnic distribution of inflammatory bowel disease in the United States. Gastroenterology. 2023;165:1197–1205. doi:10.1053/j.gastro.2023.07.003
¹⁰ Heydari K, Rahnavard M, Ghahramani S, Hoseini A, Alizadeh-Navaei R, Rafati S, Raei M, Vahidipour M, Salehi F, Motafeghi F, Neshat S, Moosazadeh M, Yousefi M, Pourali A, Rasouli K, Shokrirad S, Lotfi P, Beladi SA, Hadizadeh Neisanghalb M, Sheydaee F, Moghadam S. Global prevalence and incidence of inflammatory bowel disease: a systematic review and meta-analysis of population-based studies. Gastroenterol Hepatol Bed Bench. 2025;18(2):132-146. doi: 10.22037/ghfbb.v18i2.3105. PMID: 40936779; PMCID: PMC12421925.
¹¹ Talicia^® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com.

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SOURCE RedHill Biopharma Ltd.

FAQ

What did RedHill (CPIX) announce about RHB-204's MAP-killing results on April 30, 2026?

RHB-204 showed comparable MAP killing to RHB-104 in spot and phage assays, with lower doses of two actives. According to RedHill, these are in vitro results supporting further clinical development, not clinical proof of efficacy in patients.

How does RHB-204 compare to RHB-104 in prior clinical results for Crohn's disease (CPIX)?

RHB-204 matched RHB-104 in vitro MAP killing while using reduced doses of two components. According to RedHill, RHB-104 previously achieved a 36.7% remission vs 22.4% placebo in Phase 3 (64% relative improvement).

What is RedHill's (CPIX) planned clinical path for RHB-204 in MAP-positive Crohn's disease?

RedHill plans a Phase 2 study in a defined MAP-positive CD population and is seeking non-dilutive funding. According to RedHill, the design follows FDA guidance and partners provide MAP diagnostics to support enrollment.

What regulatory and patent protections does RHB-204 have that could affect CPIX investors?

RHB-204 holds Fast Track, Orphan and QIDP designations and is patent protected through 2041. According to RedHill, these confer potential exclusivities and could accelerate review, but specific approvals remain pending.

How might RHB-204 affect the Crohn's disease market relevant to CPIX shareholders?

RHB-204 targets MAP-positive patients with an oral regimen, addressing tolerability and administration concerns. According to RedHill, the CD market may grow from $13.6B in 2024 to $19.1B by 2033, representing an opportunity if clinical approval is achieved.