Good news flowed in at RedHill Biopharma Ltd. (RDHL - Free Report) when the company received a positive feedback from the UK and Swedish pharmaceutical regulatory agencies on its candidate, RHB-104. RedHill Biopharma, an Israeli biopharmaceutical company, held scientific advice meetings with the UK Medicines and Healthcare Products Regulatory Agency and the Swedish Medical Products Agency regarding the European phase III development plan of RHB-104 for Crohn's disease.
Based on the feedback from these regulatory agencies, the company plans to initiate a double-blind, placebo-controlled, phase III MAP Europe study (n = 360) to evaluate the safety and efficacy of RHB-104 in patients suffering from moderately active Crohn's disease.
RedHill Biopharma also plans to initiate a double-blind, placebo-controlled, first phase III MAP U.S. study (n = 240) on RHB-104 for the treatment of Crohn's disease in North America and Israel. The company intends to initiate the MAP U.S. study in the coming weeks and the MAP Europe study shortly after that.
Crohn's disease represents a lucrative market, which currently includes drugs like UCB’s (UCBJF - Free Report) Cimzia.
Apart from Crohn’s disease, RedHill Biopharma is also evaluating the candidate for the treatment of multiple sclerosis (MS) and rheumatoid arthritis (RA). While, for the MS indication, a proof of concept phase IIa study in ongoing, for the RA indication the company plans to initiate a proof of concept phase IIa study.
RedHill Biopharma currently carries a Zacks Rank #2 (Buy). Companies that look more attractive at present include Actelion Ltd. and Gilead Sciences Inc. (GILD - Free Report) with a Zacks Rank #1 (Strong Buy).