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By Meg Flippin, Benzinga
A potential, previously unexplored pathway for fighting diabetes and obesity-related disorders may have been unveiled by RedHill Biopharma (NASDAQ: RDHL), a specialty biopharmaceutical company, and its partner Apogee Biotechnology Corp., who are busy developing what may be an interesting new approach in the obesity and diabetes market.
The company is testing opaganib in a range of metabolic disease models designed to show its potential to prevent and treat type 2 diabetes and other obesity-related diseases and recently received positive in vivo results. The positive results of early trials are good news for RedHill Biopharma given the global obesity-diabetes drug market opportunity is huge, projected to reach $100 billion by 2030. It’s being driven largely by Glucagon-like peptide-1 (GLP-1) inhibitors like Novo Nordisk’s (NYSE: NVO) Ozempic and Wegovy (semaglutide), Eli Lilly’s (NYSE: LLY) Trulicity (dulaglutide) and Mounjaro (tirzepatide) and sodium glucose cotransporter-2 (SGLT2) inhibitors such as Boehringer Ingelheim’s Jardiance (Empagliflozin), reports RedHill. If RedHill is right about opaganib, it could join those ranks.
“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 Corp., Redhill’s partner who led the testing of opaganib for the treatment and prevention 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 evaluation of opaganib in obesity-related disorders.”
Opaganib Slows Weight Gain
Earlier this week RedHill announced that in vivo studies conducted by RedHill’s partner, Apogee, yielded positive results. The studies looked at the impact opaganib had on weight gain and glucose tolerance in a high-fat diet (HFD) model. They demonstrated opaganib suppressed HFD-induced body weight gain, loss of glucose tolerance and fat deposition. Additionally, opaganib reduced weight gain and restored glucose tolerance in an already obese HFD model, suggesting its potential for treating, not just preventing, obesity-related disorders, reports RedHill Biopharma.
“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.”
With multiple U.S. government collaborations ongoing, opaganib, RedHill Biopharma’s first-in-class new chemical entity with anti-inflammatory, anti-cancer and antiviral activity, is a host-directed, potentially broad-acting, orally administered small molecule drug with demonstrated safety & efficacy profiles. It is in development for multiple oncology, viral, inflammatory and diabetes and obesity-related indications, including COVID-19, Ebola, acute respiratory distress syndrome (ARDS) and radio/chemical protection.
More Than Fighting Diabetes
But it’s not just in fighting diabetes and obesity-related disorders where RedHill is making progress. Adding to its commercialization by RedHill in the U.S., the company just launched Talicia (omeprazole magnesium, amoxicillin and rifabutin) in the United Arab Emirates (UAE) – making it available by prescription to treat adults with Helicobacter pylori (H. pylori) infection.
Talicia is the first approved low-dose rifabutin-containing all-in-one combination product in the UAE specifically designed to treat H. pylori. The commercial launch of Talicia in the UAE triggers RedHill’s eligibility for additional potential milestone payments, minimum sales payments and tiered royalties up to mid-teens on net sales.
Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia was approved by the U.S. FDA for the treatment of H. pylori infection in adults. In a pivotal Phase 3 study, Talicia demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001).
“As one of the strongest risk factors for gastric cancer, H. pylori is a major public health concern,” said Rick Scruggs, President & Chief Commercial Officer at RedHill. “With 41% of the UAE population infected by H. pylori and the alarming failure rates of clarithromycin-based therapies, there is a significant medical need for a highly effective first-line H. pylori therapy. Our efforts to make Talicia available to patients in more countries continue as we work to explore additional opportunities with existing and potential partners.”
From preventing diabetes and obesity-related diseases to fighting H. pylori, RedHill Biopharma seems to be making strides with its key drug compounds. Early testing shows promise, potentially making this a company worth watching. To learn more about RedHill Biopharma’s pipeline, click here.
Featured photo by Diana Polekhina on Unsplash.
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