Newly Published Positive Phase 3 Data Demonstrates 64% Increased Efficacy with RedHill's RHB-104 in Crohn's Disease
RedHill Biopharma (Nasdaq: RDHL) has announced positive Phase 3 data for RHB-104, a triple antimicrobial therapy targeting Mycobacterium avium subspecies paratuberculosis (MAP) in Crohn's disease. The study, published in the journal Antibiotics, showed that RHB-104 plus standard of care (SoC) was 64% more effective than SoC alone. The primary endpoint of clinical remission at week 26 was achieved in 36.7% of RHB-104 patients compared to 22.4% of placebo patients (p=0.0048). The safety profile was similar to placebo. This data supports the hypothesis of a Mycobacterial basis for Crohn's disease and opens a potential new avenue for treatment. The Crohn's disease market was valued at over $13 billion in 2023.
RedHill Biopharma (Nasdaq: RDHL) ha annunciato dati positivi di Fase 3 per RHB-104, una terapia antimicrobica tripla mirata al Mycobacterium avium subspecie paratuberculosis (MAP) nella malattia di Crohn. Lo studio, pubblicato nella rivista Antibiotics, ha mostrato che RHB-104 associato allo standard di cura (SoC) era 64% più efficace rispetto al solo SoC. L'obiettivo primario di remissione clinica alla settimana 26 è stato raggiunto nel 36,7% dei pazienti trattati con RHB-104 rispetto al 22,4% dei pazienti in placebo (p=0,0048). Il profilo di sicurezza è stato simile a quello del placebo. Questi dati supportano l'ipotesi di una base micobatterica per la malattia di Crohn e aprono una nuova potenziale opportunità di trattamento. Il mercato della malattia di Crohn è stato valutato oltre $13 miliardi nel 2023.
RedHill Biopharma (Nasdaq: RDHL) ha anunciado datos positivos de Fase 3 para RHB-104, una terapia antimicrobiana triple dirigida contra Mycobacterium avium subespecie paratuberculosis (MAP) en la enfermedad de Crohn. El estudio, publicado en la revista Antibiotics, demostró que RHB-104 más el tratamiento estándar (SoC) fue un 64% más efectivo que el SoC por sí solo. El objetivo primario de remisión clínica en la semana 26 se alcanzó en 36,7% de los pacientes con RHB-104 en comparación con el 22,4% de los pacientes con placebo (p=0,0048). El perfil de seguridad fue similar al del placebo. Estos datos apoyan la hipótesis de una base micobacteriana para la enfermedad de Crohn y abren una nueva vía potencial para el tratamiento. El mercado de la enfermedad de Crohn fue valorado en más de $13 mil millones en 2023.
레드힐 바이오파마 (Nasdaq: RDHL)는 크론병에서 마이코박테리움 아비움 아종 패라투베르큘로시스(MAP)를 겨냥한 삼중 항균 요법인 RHB-104의 긍정적인 3상 데이터를 발표했습니다. 항생제 저널에 발표된 이 연구에서는 RHB-104와 표준 치료(SoC)를 병용한 경우 64% 더 효과적이라는 결과를 보였습니다. 26주 차 임상 관해를 달성한 RHB-104 환자는 36.7%였고, 위약 환자는 22.4%였습니다(p=0.0048). 안전성 프로필은 위약과 유사했습니다. 이 데이터는 크론병의 미코박테리아 기초 가설을 지지하며, 새로운 치료 가능성을 열어줍니다. 2023년 크론병 시장 가치는 $130억 이상으로 평가되었습니다.
RedHill Biopharma (Nasdaq: RDHL) a annoncé des données positives de Phase 3 pour RHB-104, une thérapie antimicrobienne triple ciblant Mycobacterium avium sous-espèce paratuberculosis (MAP) dans la maladie de Crohn. L'étude, publiée dans la revue Antibiotics, a montré que RHB-104 associé aux soins standard (SoC) était 64% plus efficace que le SoC seul. L'objectif principal de rémission clinique à la semaine 26 a été atteint chez 36,7% des patients sous RHB-104, contre 22,4% des patients sous placebo (p=0,0048). Le profil de sécurité était similaire à celui du placebo. Ces données soutiennent l'hypothèse d'une base mycobactérienne pour la maladie de Crohn et ouvrent une nouvelle voie potentielle de traitement. Le marché de la maladie de Crohn a été évalué à plus de 13 milliards de dollars en 2023.
RedHill Biopharma (Nasdaq: RDHL) hat positive Phase-3-Daten für RHB-104 angekündigt, eine dreifache antimikrobielle Therapie, die auf Mycobacterium avium Unterart paratuberculosis (MAP) bei Morbus Crohn abzielt. Die Studie, die in der Zeitschrift Antibiotics veröffentlicht wurde, zeigte, dass RHB-104 zusammen mit der Standardbehandlung (SoC) 64% effektiver war als SoC allein. Der primäre Endpunkt der klinischen Remission in der Woche 26 wurde bei 36,7% der RHB-104-Patienten im Vergleich zu 22,4% der Placebo-Patienten erreicht (p=0,0048). Das Sicherheitsprofil war mit dem des Placebos vergleichbar. Diese Daten unterstützen die Hypothese einer mykobakteriellen Grundlage für Morbus Crohn und eröffnen einen potenziell neuen Behandlungsansatz. Der Markt für Morbus Crohn wurde 2023 auf über 13 Milliarden US-Dollar geschätzt.
- RHB-104 plus SoC showed 64% increased efficacy compared to SoC alone in Crohn's disease
- Primary endpoint of clinical remission at week 26 achieved with high statistical significance (36.7% vs 22.4%, p=0.0048)
- RHB-104 demonstrated a safety profile similar to placebo
- The study supports the hypothesis of a Mycobacterial basis for Crohn's disease
- RHB-104 proved beneficial to patients receiving anti-TNF agents, corticosteroids, or immunosuppressive agents
- None.
Insights
The publication of positive Phase 3 data for RedHill Biopharma's RHB-104 in Crohn's disease represents a significant breakthrough in the field of gastroenterology. The study's results, showing a
Key points to consider:
- The primary endpoint of clinical remission at week 26 was achieved in
36.7% of RHB-104 patients versus22.4% in the placebo group (p=0.0048). - The study included patients on various treatments, including anti-TNF agents, corticosteroids and immunosuppressants, suggesting RHB-104's potential as an add-on therapy.
- The safety profile was similar to placebo, which is important for long-term treatment options in chronic conditions like Crohn's disease.
This data supports the hypothesis of a Mycobacterial basis for Crohn's disease, potentially opening new avenues for treatment. The ability to target Mycobacterium avium subspecies paratuberculosis (MAP) could represent a paradigm shift in how we approach inflammatory bowel diseases.
The positive Phase 3 results for RHB-104 could have significant implications for RedHill Biopharma and the broader Crohn's disease market. Consider these financial aspects:
- The Crohn's disease market was valued at
$13 billion in 2023, indicating substantial revenue potential for effective treatments. - RHB-104's oral administration and efficacy as an add-on therapy could position it favorably against existing treatments like Humira®, Remicade® and Stelara®.
- The potential paradigm shift in Crohn's disease treatment could disrupt the market, possibly affecting the market share of current major players like AbbVie, Janssen and Pfizer.
However, it's important to note that further regulatory approvals and market acceptance will be important for RHB-104's commercial success. The company's ability to secure partnerships for further development and commercialization will be a key factor to watch. Investors should also consider the potential impact on RedHill's pipeline and financial position as they progress this promising candidate.
The results of this Phase 3 study for RHB-104 are indeed groundbreaking in the field of Crohn's disease treatment. Here's why this is significant from a clinical perspective:
- The study supports the long-debated hypothesis of a Mycobacterial basis for Crohn's disease, potentially revolutionizing our understanding of the disease's etiology.
- RHB-104's efficacy in patients already receiving various standard treatments suggests it could be a valuable addition to the current treatment arsenal, particularly for difficult-to-treat cases.
- The oral administration of RHB-104 could offer a more convenient option compared to injectable biologics, potentially improving patient compliance and quality of life.
However, it's important to note that while these results are promising, further studies may be needed to fully establish RHB-104's long-term efficacy and safety profile. The medical community will be keen to see how this treatment performs in real-world settings and whether it can modify the disease course over extended periods. If further validated, this approach could lead to a significant shift in Crohn's disease management strategies.
Newly published in the peer-reviewed journal Antibiotics, the 331-patient Phase 3 Crohn's disease study data shows the primary endpoint of clinical remission at week 26 was achieved, with high statistical significance, in
The advanced stage clinical data demonstrating the potential efficacy of oral RHB-104 triple antimicrobial therapy targeting Mycobacterium avium subspecies paratuberculosis (MAP,) supports the paradigm-changing hypothesis of a Mycobacterial basis to Crohn's disease, where high unmet medical need exists
"This ground-breaking data shows that RHB-104, which contains antimicrobial therapy directed against Mycobacterium paratuberculosis, or MAP, which typically infects cattle, appears to be effective for the treatment of Crohn's disease - potentially opening a new avenue of therapy directed against its possible cause," said Dr. David Y. Graham, Professor of Medicine and Molecular Virology and Microbiology at Baylor College of Medicine, the lead investigator of the study. Dr. Graham added: "It is particularly important to note that RHB-104 proved beneficial to patients receiving anti-TNF agents, corticosteroids or immunosuppressive agents, and may also have a role as an add-on therapy for patients not responding to their current treatment."
The Crohn's disease market was valued at more than
The data from the randomized, double-blind, placebo-controlled 331-patient Phase 3 study of anti-mycobacterial therapy (RHB-104) in active Crohn's disease, was published in the peer-reviewed journal, Antibiotics[2]. In the global study, conducted across more than 100 sites across the
"This study was designed based on the hypothesis that infection with MAP is the primary cause of Crohn's disease and that antimicrobial therapy designed to treat MAP would favorably influence the outcome of Crohn's disease," said study lead investigator, Dr. David Y. Graham, Professor of Medicine and Molecular Virology and Microbiology at Baylor College of Medicine and the Michael E. DeBakey Veterans Administration Hospital in
"Crohn's disease causes immense suffering to millions of patients globally and sometimes leads to death due to various complications. Recognizing this, RedHill is firmly committed to the RHB-104 potential paradigm-changing Phase 3-stage program. It has been more than 100 years since Scottish surgeon, Dalziel, first sowed the seeds of a possible link between MAP and Crohn's. Evidence has grown of MAP involvement in the etiology of Crohn's, being associated with immune signaling dysregulation and being identified in over
About Crohn's Disease:
Effecting an estimated one million Americans, Crohn's disease 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 a form of IBD causing inflammation of digestive tract tissue that can lead to abdominal pain, severe diarrhea, fatigue, weight loss and malnutrition. Different areas of the digestive tract can be affected by the inflammation caused by Crohn's disease, but it is often associated with the small intestine. However, this inflammation can often spread further and deeper into the bowel.
The Crohn's disease market was valued at more than
About RHB-104:
RHB-104 is a proprietary, orally administered antibiotic combination therapy, with intracellular, antimycobacterial and anti-inflammatory properties. The randomized, double-blind, placebo-controlled, first Phase 3 study with RHB-104 in Crohn's disease (the MAP US study) successfully met both its primary endpoint and key secondary endpoints and presented the benefit of RHB-104 as an add-on therapy to standard-of-care treatments for Crohn's disease, including anti-TNF agents. The company also reported supportive top-line results from an open-label extension Phase 3 study (MAP US2) evaluating the safety and efficacy of RHB-104 in subjects with persistent active Crohn's disease after 26 weeks of blinded study therapy in MAP US. RHB-104 was developed based on the hypothesis that Crohn's disease is caused by Mycobacterium avium subspecies paratuberculosis (MAP) infection in susceptible patients. The development of RHB-104 is consistent with the growing awareness of the possibility that a bacterially-induced dysregulated immune system may contribute to the pathogenesis of various autoimmune diseases of unknown etiology.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults[4], and Aemcolo®, for the treatment of travelers' diarrhea in adults[5]. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class oral broad-acting, host-directed SPHK2 selective inhibitor with potential for pandemic preparedness, targeting multiple indications with a
More information about the Company is available at www.redhillbio.com / X.com/RedHillBio.
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, including, but not limited to, statements regarding the intended use of net proceeds from the offering, may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include statements regarding the risk that the Company will not comply with the listing requirements of the Nasdaq Capital Market ("Nasdaq") to remain listed for trading on Nasdaq, the addition of new revenue generating products, out-licensing of the Company's development pipeline assets, timing of opaganib's development for Acute Radiation Syndrome, non-dilutive development funding from RHB-107 and its inclusion in a key platform study. 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, market and other conditions, the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that acceptance onto the RNCP Product Development Pipeline 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 opaganib for any indication, the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials; the risk that the FDA pre-study requirements will not be met and/or that the Phase 3 study of RHB-107 in COVID-19 outpatients will not be approved to commence or if approved, will not be completed or, should that be the case, that we will not be successful in obtaining alternative non-dilutive development funding for RHB-107, the risk that HB-107's late-stage development for non-hospitalized COVID-19 will not benefit from the resources redirected from the terminated RHB-204 Phase 3 study, that the Phase 2/3 COVID-19 study for RHB-107 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 COVID-19 studies for opaganib and RHB-107 are likely to be required, as well as risks and uncertainties associated with 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 a commercial companion diagnostic for the detection of MAP; (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® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the
Company contact:
Adi Frish
Chief Corporate & Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
Category: R&D
[1] RHB-104 is an investigational new drug, not available for commercial distribution in
[2] Graham DY, et al. Randomized, Double-Blind, Placebo-Controlled Study of Anti-Mycobacterial Therapy (RHB-104) in Active Crohn's Disease. Antibiotics. 2024; 13(8):694. https://doi.org/10.3390/antibiotics13080694
[3] https://www.gminsights.com/industry-analysis/crohns-disease-treatment-market#:~:text=Crohn's%20Disease%20Treatment%20Market%20size%20was%20valued%20at%20USD%2013.3,increasing%20prevalence%20of%20Chron's%20disease.
[4] 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.
[5] Aemcolo® (rifamycin) is indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli in adults. For full prescribing information see: www.Aemcolo.com.
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