RedHill Announces Positive Obesity and Diabetes Results with Opaganib
RedHill Biopharma (Nasdaq: RDHL) has announced positive results from multiple in vivo studies showing the impact of opaganib, a sphingosine kinase-2 (SPHK2) inhibitor, on weight gain and glucose tolerance in a high fat diet (HFD) model. The studies support the potential clinical use of opaganib for the prevention and therapy of Type 2 diabetes and other obesity-related disorders.
Opaganib's ability to modulate multiple signaling pathways through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells provides a strong rationale for its evaluation in obesity-related disorders. The studies showed that opaganib therapy suppressed HFD-induced body weight gain, loss of glucose tolerance, and fat deposition. It also reduced weight gain and restored glucose tolerance in an already obese HFD model.
The global obesity-diabetes drugs market is projected to be worth around $100 billion by 2034, driven by GLP-1 inhibitors and SGLT2 inhibitors.
RedHill Biopharma (Nasdaq: RDHL) ha annunciato risultati positivi provenienti da diversi studi in vivo che mostrano l'impatto di opaganib, un inibitore della sphingosine chinasi-2 (SPHK2), sul guadagno di peso e la tolleranza al glucosio in un modello di dieta ad alto contenuto di grassi (HFD). Gli studi supportano il potenziale utilizzo clinico di opaganib nella prevenzione e terapia del diabete di tipo 2 e di altri disturbi correlati all'obesità.
La capacità di opaganib di modulare più vie di segnalazione attraverso l'inibizione simultanea di tre enzimi che metabolizzano i sfingolipidi nelle cellule umane fornisce una base solida per la sua valutazione nei disturbi legati all'obesità. Gli studi hanno dimostrato che la terapia con opaganib ha soppressato il guadagno di peso indotto dalla dieta ad alto contenuto di grassi, la perdita di tolleranza al glucosio e il deposito di grasso. Ha anche ridotto il guadagno di peso e ripristinato la tolleranza al glucosio in un modello di obesità già esistente.
Il mercato globale dei farmaci contro l'obesità e il diabete è previsto valere circa 100 miliardi di dollari entro il 2034, sostenuto dagli inibitori GLP-1 e dagli inibitori SGLT2.
RedHill Biopharma (Nasdaq: RDHL) ha anunciado resultados positivos de múltiples estudios in vivo que muestran el impacto de opaganib, un inhibidor de la esfingosina quinasa-2 (SPHK2), sobre el aumento de peso y la tolerancia a la glucosa en un modelo de dieta alta en grasas (HFD). Los estudios respaldan el potencial uso clínico de opaganib para la prevención y terapia de la diabetes tipo 2 y otros trastornos relacionados con la obesidad.
La capacidad de opaganib para modular múltiples vías de señalización a través de la inhibición simultánea de tres enzimas que metabolizan esfingolípidos en células humanas proporciona una fuerte justificación para su evaluación en trastornos relacionados con la obesidad. Los estudios mostraron que la terapia con opaganib suprimió el aumento de peso inducido por la HFD, la pérdida de tolerancia a la glucosa y la deposición de grasa. También redujo el aumento de peso y restauró la tolerancia a la glucosa en un modelo HFD de obesidad ya existente.
Se prevé que el mercado global de medicamentos para la obesidad y la diabetes tenga un valor de alrededor de $100 mil millones para 2034, impulsado por los inhibidores GLP-1 y los inhibidores SGLT2.
레드힐 바이오파마(RedHill Biopharma)(Nasdaq: RDHL)는 여러 인 비보 연구 결과에서 긍정적인 결과를 발표했습니다. 이 연구는 스핑고신 키나제-2(SPHK2) 억제제인 오파가니브(opaganib)가 고지방 식이(HFD) 모델에서 체중 증가와 포도당 내성에 미치는 영향을 보여줍니다. 이러한 연구 결과는 제2형 당뇨병 및 기타 비만 관련 질환의 예방 및 치료를 위한 오파가니브의 잠재적 임상 사용 가능성을 지지합니다.
오파가니브는 인간 세포에서 세 가지 스핑올리피드 대사 효소를 동시에 억제함으로써 여러 신호 경로를 조절하는 능력이 있어 비만 관련 질환에서의 평가를 위한 강력한 근거를 제공합니다. 연구 결과, 오파가니브 치료는 HFD로 인한 체중 증가, 포도당 내성 손실 및 지방 침착을 억제했습니다. 또한 이미 비만인 HFD 모델에서 체중 증가를 줄이고 포도당 내성을 회복시켰습니다.
전 세계 비만-당뇨병 약물 시장은 2034년까지 약 1000억 달러에 이를 것으로 예상됩니다, GLP-1 억제제 및 SGLT2 억제제에 의해 주도됩니다.
RedHill Biopharma (Nasdaq: RDHL) a annoncé des résultats positifs issus de plusieurs études in vivo, montrant l'impact de l'opaganib, un inhibiteur de la sphingosine kinase-2 (SPHK2), sur la prise de poids et la tolérance au glucose dans un modèle de régime riche en graisses (HFD). Les études soutiennent l'utilisation clinique potentielle de l'opaganib pour la prévention et le traitement du diabète de type 2 ainsi que d'autres troubles liés à l'obésité.
La capacité de l'opaganib à moduler plusieurs voies de signalisation par l'inhibition simultanée de trois enzymes métabolisant les sphingolipides dans les cellules humaines fournit un fort soutien à son évaluation dans les troubles liés à l'obésité. Les études ont montré que la thérapie par opaganib a supprimé la prise de poids induite par le HFD, la perte de tolérance au glucose et le dépôt de graisse. Elle a également réduit la prise de poids et restauré la tolérance au glucose dans un modèle HFD déjà obèse.
Le marché mondial des médicaments contre l'obésité et le diabète devrait atteindre une valeur d'environ 100 milliards de dollars d'ici 2034, soutenu par les inhibiteurs de GLP-1 et les inhibiteurs de SGLT2.
RedHill Biopharma (Nasdaq: RDHL) hat positive Ergebnisse aus mehreren in vivo Studien bekannt gegeben, die die Auswirkungen von Opaganib, einem Inhibitor der Sphingosin-Kinase-2 (SPHK2), auf Gewichtszunahme und Glukosetoleranz in einem hochfettigen Diät (HFD)-Modell zeigen. Die Studien unterstützen den potenziellen klinischen Einsatz von Opaganib zur Prävention und Therapie von Typ-2-Diabetes und anderen adipositas-assoziierten Erkrankungen.
Die Fähigkeit von Opaganib, mehrere Signalkaskaden durch die gleichzeitige Hemmung von drei sphingolipidmetabolisierenden Enzymen in menschlichen Zellen zu modulieren, bietet eine starke Grundlage für seine Evaluierung bei fettrelevanten Erkrankungen. Die Studien zeigten, dass die Opaganib-Therapie die durch die HFD induzierte Gewichtszunahme, den Verlust der Glukosetoleranz und die Fettablagerung unterdrückte. Außerdem reduzierte es die Gewichtszunahme und stellte die Glukosetoleranz in einem bereits adipösen HFD-Modell wieder her.
Der globale Markt für Medikamente gegen Fettleibigkeit und Diabetes wird voraussichtlich bis 2034 rund 100 Milliarden Dollar wert sein, angetrieben von GLP-1-Inhibitoren und SGLT2-Inhibitoren.
- Positive results from multiple in vivo studies supporting opaganib's potential for treating diabetes and obesity-related disorders
- Opaganib demonstrated ability to suppress HFD-induced body weight gain, loss of glucose tolerance, and fat deposition
- Opaganib showed potential for treating, not just preventing, obesity-related disorders in already obese HFD model
- Opaganib is the first clinical drug to target three key enzymes in the sphingolipid metabolism pathway
- None.
Insights
The positive results from multiple in vivo studies on opaganib's impact on weight gain and glucose tolerance in high-fat diet models are highly promising for RedHill Biopharma. This data supports opaganib's potential as a novel therapy for Type 2 diabetes and obesity-related disorders, addressing a massive market projected to reach
Opaganib's unique mechanism of action, targeting three key enzymes in sphingolipid metabolism, sets it apart from current market leaders like GLP-1 inhibitors and SGLT2 inhibitors. This multi-targeted approach could potentially offer broader benefits in managing metabolic diseases. The drug's ability to both prevent and treat obesity-related disorders in animal models is particularly noteworthy, suggesting versatility in clinical applications.
However, it's important to note that these are preclinical results. The translation to human efficacy and safety remains to be demonstrated in clinical trials, which will be critical for opaganib's future in this competitive market.
RedHill Biopharma's announcement could significantly impact its market position. The obesity-diabetes market, projected at
Opaganib's potential to compete with established players like Novo Nordisk and Eli Lilly is intriguing. However, investors should consider the long road ahead in drug development. Clinical trials, regulatory approvals and market penetration will require substantial time and investment.
RedHill's current market cap doesn't reflect this potential, suggesting upside if milestones are met. Yet, the risk is high given the early stage and fierce competition. The company's ability to fund development and potentially partner with larger pharma companies will be crucial. Investors should monitor upcoming clinical trial announcements and financial reports to gauge progress and funding adequacy.
RedHill's opaganib represents an innovative approach in the obesity-diabetes space. Its mechanism of targeting sphingolipid metabolism differentiates it from current market leaders, potentially offering a new paradigm in treatment.
The drug's demonstrated ability to both prevent and reverse obesity-related symptoms in animal models is particularly compelling. If replicated in humans, this could position opaganib as a versatile option for both prevention and treatment, potentially capturing a larger market share.
However, the path from preclinical to approved drug is long and fraught with challenges. RedHill will need to demonstrate not only efficacy but also safety and superiority or differentiation from established treatments. The company's experience with opaganib in other indications may expedite development, but competition is fierce in this lucrative market.
Investors should closely monitor upcoming clinical trial designs and results, as well as RedHill's strategy for navigating the regulatory landscape and potential partnerships to support commercialization.
The global obesity-diabetes drugs market is projected to be worth around
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Positive results from multiple in vivo studies show the impact of sphingosine kinase-2 (SPHK2) inhibition in various models of metabolic disease, supporting the potential of opaganib therapy for diabetes and obesity-related disorders
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With multiple
"Sphingolipid metabolism is implicated in insulin resistance, β-cell disruption, adipocyte function, inflammation and immune regulation, vascular complications and energy metabolism – all significant components of obesity, diabetes and their associated complications," said Charles D. Smith, Ph.D. Founder and CEO of Apogee Biotechnology Corporation. "Opaganib's ability to modulate multiple signaling pathways through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells provides a strong rationale for evaluation of opaganib in obesity-related disorders."
The studies were designed to examine some of the most fundamental aspects of diabetes and obesity-related disease. The encouraging outcomes showed the benefit of opaganib therapy in suppression of HFD-induced body weight gain, loss of glucose tolerance and fat deposition. Additionally, opaganib treatment reduced weight gain and restored glucose tolerance in an already obese HFD model, suggesting its potential for treating, not just preventing, obesity-related disorders.
"Sphingolipid metabolism is a key pathway in many diseases, including obesity, but has not been adequately examined as a therapeutic target for human therapy," said Dr. Mark Levitt, Chief Scientific Officer at RedHill. "Opaganib, which acts as a sphingosine competitor, is the first clinical drug to target three key enzymes in this pathway."
The global obesity-diabetes drugs market is projected to be worth around
About Opaganib (ABC294640)
Opaganib, a proprietary investigational host-directed and potentially broad-acting drug, is a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple potential diseases, including obesity-related syndromes, prostate cancer and cholangiocarcinoma (bile duct cancer), gastrointestinal acute radiation syndrome (GI-ARS), Sulfur Mustard exposure, COVID-19, Ebola and other viruses as part of pandemic preparedness.
Opaganib's host-directed action is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS).
Opaganib has been selected for evaluation by two
Opaganib has demonstrated antiviral activity against SARS-CoV-2, multiple variants, and several other viruses, such as Influenza A and Ebola. Opaganib delivered a statistically significant increase in survival time when given at 150 mg/kg twice a day (BID) in a United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in vivo Ebola virus study, making it the first host-directed molecule to show activity in Ebola virus disease. Opaganib also recently demonstrated a distinct synergistic effect when combined individually with remdesivir (Veklury®, Gilead Sciences Inc.), significantly improving potency while maintaining cell viability, in a
Being host-targeted, and based on data accumulated to date, opaganib is expected to maintain effect against emerging viral variants. In prespecified analyses of Phase 2/3 clinical data in hospitalized patients with moderate to severe COVID-19, oral opaganib demonstrated improved viral RNA clearance, faster time to recovery and significant mortality reduction in key patient subpopulations versus placebo on top of standard of care. Opaganib has demonstrated its safety and tolerability profile in more than 470 people in multiple clinical studies and expanded access use. Data from the opaganib global Phase 2/3 study was published in medRxiv.
Opaganib has received Orphan Drug designation from the FDA for the treatment of cholangiocarcinoma and has undergone studies in advanced cholangiocarcinoma (Phase 2a) and prostate cancer. Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission.
Opaganib has also shown positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, radioprotection, viral, inflammatory, and gastrointestinal indications.
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[3], and Aemcolo®, for the treatment of travelers' diarrhea in adults[4]. 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 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 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 Company's ability to regain compliance with the Nasdaq Capital Market's minimum bid price requirements; 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 RHB-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, and 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; 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] https://www.futuremarketinsights.com/reports/obesity-diabetes-drugs-market
[2] Opaganib is an investigational new drug, not available for commercial distribution.
[3] 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.
[4] 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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SOURCE RedHill Biopharma Ltd.
FAQ
What are the key findings of RedHill Biopharma's (RDHL) opaganib studies for obesity and diabetes?
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