Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.
Last week, Athersys, Inc. (ATHX) announced the completion of the enrolment process of a phase II study on its MultiStem cell therapy. Athersys is developing MultiStem for ulcerative colitis in collaboration with Pfizer Inc. (PFE). The randomized, double-blind, placebo-controlled, multi-center phase II study will evaluate the safety and efficacy of MultiStem therapy in patients suffering from moderate-to-severe ulcerative colitis.
The primary objective of the study is to evaluate the incidence and severity of adverse events over 16 weeks. Moreover, it will also evaluate the change in endoscopic score (measured by modified Baron score) at the end of 8 weeks along with changes in the Mayo rectal bleeding sub-score at weeks four and eight. Athersys will also evaluate disease indicators and markers over the study duration.
Athersys intends to announce the results from the phase II study in two parts with the initial results expected around April or May next year. The next part results are expected to be available towards the end of the second quarter of 2014.
We note that Athersys is also developing MultiStem for treating inflammatory bowel disease, ischemic stroke, damage caused by myocardial infarction, and for the prevention of graft-versus-host disease (GvHD). Earlier in the month, MultiStem was granted orphan drug designation in Europe for the GvHD indication. The candidate already has an orphan drug designation in the U.S. for this indication.
We are encouraged by the pipeline progress at Athersys. We expect investor focus to stay on the company’s pipeline going forward.
Athersys carries a Zacks Rank #3 (Hold). However, some better-ranked stocks include Vanda Pharmaceuticals, Inc. (VNDA) and Jazz Pharmaceuticals (JAZZ). Both stocks carry a Zacks Rank #1 (Strong Buy).