Ulcers aren’t caused by stress, but by a bacteria called Helicobacter pylori (H. pylori) – and Israeli biotech firm RedHill Biopharma on Monday announced that the latest study of its RHB-105 treatment showed that it was some 20 percent more effective in killing H. pylori than current treatment methods.
Israeli biotech firm RedHill Biopharma announced Monday that the latest study of its anti-ulcer treatment showed it to be some 20 percent more effective than current methods
As a result, RedHill’s stock soared more than 40% on the Tel Aviv Stock Exchange Monday, and was up a similar amount in pre-market trading on the NASDAQ, where it is dual-listed.
The company announced the results of its Phase III trial for its RHB-105 treatment, a proprietary small molecule orally-administered drug that attacks and kills Helicobacter pylori. H. pylori is a bacterium proven to be a major cause of ulcers and a major contributor to gastroenteritis, gastric cancer, and other stomach-related maladies.
RHB-105 “demonstrated 89.4% efficacy in eradicating H. pylori infection,” compared with standard antibiotic treatments “with historical standard of care efficacy levels of 70%,” the company said. “No serious adverse events, new or unexpected safety issues were noted in the study,” it added.
For years, scientists believed that stress was the main cause of ulcers – until discovering in 1982 that it was a the H. pylori bug that was responsible. H. pylori is very common; as many as two-thirds of the world’s population carry it in their bodies. The germ settles in the stomach and attacks the lining of the stomach wall, which protects that organ from the digestive acids secreted in the stomach.
Spread by unsanitary food or contaminated water, H. pylori is responsible for illnesses from stomachaches on up. If enough of the germ gets into the stomach and remains there long enough to sufficiently weaken the stomach’s walls, ulcers or other diseases can develop, although scientists are not sure how and why the germ is more lethal for some people than others.
Over 100 test subjects were given RHB-105 directly at 13 different clinical sites in the US, and the results were compared with the historic results of the usual course of treatment, including proton pump inhibitors (PPI), which reduce the stomach’s production of acid, and antibiotics. RHB-105 is administered in pill form and is a combination of two antibiotics and a PPI.
A meeting between the company and FDA officials is set for the near future, RedHill announced.
RHB-105 was designated by the FDA last November as a Qualified Infectious Disease Product (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act, which is intended to incentivize the development of new antibiotic drugs for the treatment of serious or life-threatening infections. The designation provides for a fast-track path to approval in a market that is estimated to be worth as much as $5 billion worldwide – a market the company would have to itself for as much as 13 years, under the program’s rules.
The next stage study is likely to be the last before approval, an industry source close to the company told The Times of Israel.
“That study would probably pit RHB-105 against standard treatments to confirm the Phase II results, and at that point it would be approved and ready for the market. But the company may seek to monetize the drug even before, by licensing the rights to a large pharmaceutical firm. There has been a great deal of interest by big pharma firms in what RedHill is doing, and a deal like that could be the company’s next move,” the source said.
Last year, RedHill entered into a licensing agreement with pharmaceutical firm Salix for its RHB-106 encapsulated formulation for bowel treatment, and is in the midst of a Phase IIa study for RHB-104, a treatment for multiple sclerosis and Crohn’s Disease.
The study was submitted to an independent review board, led by Prof. David Graham, M.D., M.A.C.G., of the Baylor College of Medicine, a top authority in the field of gastric cancer and H. pylori infection.
“The outstanding results of the RHB-105 Phase III study, which demonstrated a 89.4% cure rate of H. pylori, are consistent with the hypothesis that this may represent a promise for a new and improved treatment for H. pylori infection, and could significantly contribute to the prevention of gastric cancer, MALT lymphoma and other gastrointestinal diseases and conditions,” said Graham. “Given the current high levels of antibiotic resistance and treatment failures with current standard of care therapies, RHB-105 could become, if approved, a best-in-class treatment, improving and potentially saving patients’ lives.”
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