RedHill Biopharma To Report Top-line Results From RHB-105 Phase III In June

(RTTNews) - RedHill Biopharma Ltd. (RDHL) issued an update on its development pipeline and anticipated key milestones. The company expects top-line results from the first Phase III clinical study with RHB-105 in the third week of June 2015. RHB-105 was designated by the FDA as a Qualified Infectious Disease Product.

RedHill expects top-line results from the Phase III study with BEKINDA for acute gastroenteritis and gastritis, currently ongoing in the U.S., either in the fourth quarter of 2015 or the first quarter of 2016. A meeting with the FDA is planned during the third quarter of 2015 to discuss the regulatory path of BEKINDA for the indications of acute gastroenteritis and gastritis, as well as a potential filing of a New Drug Application for chemotherapy-induced nausea and vomiting.

The company expects interim analysis of the Phase III study with RHB-104 for Crohn's disease in the second half of 2016. RedHill recently received a Notice of Allowance from the USPTO for two new patents covering RHB-104. The company said last patient has been screened in the ongoing Phase IIa Proof of Concept study with RHB-104 for the treatment of multiple sclerosis, with interim results expected either in the fourth quarter of 2015 or the first quarter of 2016.

The company expects a Phase Ib/II study of ABC294640 for refractory/relapsed diffuse large B cell lymphoma, primarily funded by the National Cancer Institute/STTR, to commence either in the second or third quarter of 2015.