RedHill Biopharma Ltd., a specialty biopharmaceutical company, today announced that following a positive pre-MAA meeting it plans to submit a Marketing Authorization Application (MAA) to the UK Medicines & Healthcare products Regulatory Agency (MHRA) seeking approval for RHB-102 (Bekinda) for oncology support (management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, also referred to as CINV and RINV) in adults and children over the age of 12.

"This green light for submission from the UK's MHRA is a major milestone towards potential approval and commercialization of RHB-102 in the UK for treating chemotherapy and radiotherapy induced nausea and vomiting. The MHRA pre-MAA scientific advice meeting evaluated the available RHB-102 clinical and pharmacokinetic data generated to date," said Gilead Raday, RedHill's Chief Operating Officer, and Head of R&D. "Following the positive input from the MHRA pre-MAA review team we aim to complete our submission of for marketing authorization application of RHB-102 to the UK regulatory authorities in the second half of this year."

RHB-102 is a proprietary 24-hr bimodal release, once-daily oral tablet formulation of ondansetron, a 5-HT3 antagonist considered the gold standard in the treatment and prevention of CINV/RINV. Between 70-80% of patients undergoing chemotherapy or radiotherapy will experience nausea and/or vomiting. The global CINV/RINV market is estimated to be worth over $10 billion by 2031, with the UK market expected to grow at 6.4% CAGR, accounting for around 20% of the European market.

Data to support the submission was generated from several clinical studies including the successful U.S. Phase III GUARD study with RHB-102 24 mg for acute gastroenteritis and gastritis[iii].

About RHB-102 (BEKINDA®):

RHB-102 is a proprietary, bimodal release, once-daily oral pill formulation of the antiemetic drug ondansetron, targeting several gastrointestinal indications. RHB-102 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 MHRA, RHB-102 24 mg could become the first oral 24hr extended-release 5-HT3 antiemetic drug in the UK indicated for the treatment of CINV/RINV.

The RHB-102 Phase III GUARD gastroenteritis study results were published in JAMA Network Open3. The RHB-102 Phase II IBS-D study results were published in The American Journal of Gastroenterology.

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[v], and Aemcolo® for the treatment of travelers' diarrhea in adults[vi]. RedHill's key clinical late-stage development programs include:RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease;  opaganib (ABC294640), a first-in-class oral broad-acting, host-directed, SK2 selective inhibitor targeting multiple indications, including for pandemic preparedness, with a Phase 2/3 program for hospitalized COVID-19 and a Phase 2 program in oncology and a radiation protection program ongoing; RHB-107 (upamostat), an oral broad-acting, host-directed serine protease inhibitor with potential for pandemic preparedness, is in late-stage development for treatment of non-hospitalized symptomatic COVID-19, and is targeting multiple other cancer and inflammatory gastrointestinal diseases; RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and  RHB-102 (Bekinda), with expected UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D. More information about the Company is available at www.redhillbio.com/ twitter.com/RedHillBio.