RedHill Biopharma Ltd – ADR (NASDAQ:RDHL) released positive top-line results from the Phase III GUARD study with BEKINDA® (RHB-102) 24 mg for acute gastroenteritis and gastritis. The study successfully met its primary endpoint of efficacy, sending shares of the drug maker rising nearly 10% to $10.22.
Robert A. Silverman, MD, MS, Emergency Medicine specialist at Northwell Health and Lead Investigator of the BEKINDA® Phase III GUARD study, said: “The positive results of the Phase III GUARD study demonstrate that BEKINDA® 24 mg is beneficial in the treatment of acute gastroenteritis and gastritis and can provide patients with 24 hours of relief. Gastroenteritis is a very common illness in the U.S., with approximately 179 million cases annually. If approved by FDA, BEKINDA® may become the new standard of care helping us treat patients quickly and effectively in both the emergency and outpatient settings.”
Terry F. Plasse, MD, RedHill`s Medical Director, added: “We are excited about the positive outcome of the Phase III GUARD study, which met its efficacy primary endpoint and demonstrated the safety and tolerability of BEKINDA® 24 mg. Notably, when looking at results by initial severity of nausea, we see a treatment effect even in patients with very severe nausea at baseline, suggesting that the drug works regardless of the initial severity of gastroenteritis. We continue to analyze the data, with the final clinical study report expected in the third quarter of 2017. We look forward to presenting the data to the FDA and discussing the potential path for marketing approval of BEKINDA® 24 mg in the U.S. and whether additional clinical studies are required prior to NDA filing. We are also expecting top-line Phase II results from the clinical study of BEKINDA® 12 mg in diarrhea-predominant irritable bowel syndrome (IBS-D) in September 2017. I would like to thank the patients, investigators, clinical staff and service providers who participated in the GUARD study and commend the RedHill team for achieving this important milestone.”
BEKINDA® is a proprietary, bimodal extended-release, once-daily oral pill formulation of the antiemetic drug ondansetron, targeting several gastrointestinal indications. BEKINDA® 24 mg is intended to provide patients with relief from nausea and vomiting symptoms for a full 24-hour period with a single oral tablet. If approved for marketing by the FDA, BEKINDA® 24 mg could become the first 5-HT3 antiemetic drug in the U.S. indicated for the treatment of acute gastroenteritis and gastritis.
RedHill will continue to analyze the GUARD Phase III study top-line data, including secondary endpoints, and plans to meet with the FDA to present the data and discuss the clinical and regulatory path towards potential marketing approval of BEKINDA® 24 mg in the U.S. Additional clinical studies may be required prior to potential submission of a New Drug Application (NDA).
The top-line results from the GUARD Phase III study were provided to RedHill by an independent third party following an independent analysis and remain subject to completion of the independent review and analysis of the underlying data, including all safety, secondary and other outcome measures, and completion of the Clinical Study Report (CSR), expected in the third quarter of 2017.
On the ratings front, RedHill stock has been the subject of a number of recent research reports. In a report issued on May 4, Roth Capital analyst Scott Henry reiterated a Buy rating on RDHL, with a price target of $26, which represents a potential upside of 175% from where the stock is currently trading. On the same day, H.C. Wainwright’s Swayampakula Ramakanth reiterated a Buy rating on the stock and has a price target of $33.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Scott Henry and Swayampakula Ramakanth have a yearly average loss of 2.0% and 15.1% respectively. Henry has a success rate of 42% and is ranked #3974 out of 4578 analysts, while Ramakanth has a success rate of 29% and is ranked #4516.
RedHill Biopharma Ltd. is a biopharmaceutical company. Primarily, it is focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for the treatment of gastrointestinal and inflammatory diseases and cancer. Its current pipeline of proprietary products includes: (i) RHB-105-an oral combination therapy for the treatment of Helicobacter pylori infection with successful results from a first Phase III study; (ii) RHB-104-an oral combination therapy for the treatment of Crohn’s disease with an ongoing first Phase III study and an ongoing proof-of-concept Phase IIa study for multiple sclerosis; (iii) BEKINDA (RHB-102)-a once-daily oral pill formulation of ondansetron with an ongoing Phase III study in the U.S. for acute gastroenteritis and gastritis and an ongoing Phase II study for IBS-D; (iv) RHB-106-an encapsulated bowel preparation licensed to Salix Pharmaceuticals Ltd.; (v) YELIVA (ABC294640)-a Phase II-stage, orally-administered, first-in-class SK2 selective inhibitor targeting multiple oncology, inflammatory and gastrointestinal indications; (vi) MESUPRON-a Phase II-stage first-in-class uPA inhibitor, administered by oral capsule, targeting gastrointestinal and other solid tumors; (vii) RP101 is a Phase II-stage first-in-class Hsp27 inhibitor, administered by oral tablet, targeting pancreatic and other gastrointestinal cancers; (viii) RIZAPORT (RHB-103)-an oral thin film formulation of rizatriptan for acute migraines and with a U.S. NDA currently under discussion with the FDA and marketing authorization received in Germany in October 2015.