Opexa Therapeutics reaches enrollment target in Phase IIb trial Opexa Therapeutics reported it has reached the targeted enrollment in its Phase IIb clinical trial in Secondary Progressive Multiple Sclerosis. As of today, 180 patients with Secondary Progressive MS have been randomized in the Phase IIb ďAbili-TĒ clinical study of Tcelna. The company will also allow patients who are currently in the screening process at the time of full enrollment and who meet the trialís entry criteria to also be enrolled in the trial. The Abili-T trial is a Phase IIb study of Tcelna in patients with Secondary Progressive MS in 35 leading clinical sites in the U.S. and Canada. Each patient is receiving two annual courses of Tcelna treatment consisting of five subcutaneous injections per year. The trialís primary efficacy outcome is the percentage of brain volume change at 24 months. Top line data is expected in mid-2016. Opexa has received Fast Track designation from the U.S. FDA for Tcelna in Secondary Progressive Multiple Sclerosis. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions, as well as fill an unmet medical need and get important new drugs to patients earlier.
Opexa Therapeutics expects to submit IND for OPX-212 in mid 2015 Expects to initiate a Phase 1/2 clinical trial of OPX-212 in NMO for 2H15. Expects to apply for orphan drug designation and fast track designation for OPX-212 in 2016 or 2017. Expects to report top-line data of Abili-T Phase 2b trial of Tcelna in SPMS in 2H16.