BioCentury
ARTICLE | Clinical News

Davunetide: Phase II/III data

December 24, 2012 8:00 AM UTC

Allon said it will not allocate any additional capital to R&D for davunetide after top-line data from a double-blind, international Phase II/III trial in 313 patients with PSP showed that twice-daily 30 mg davunetide administered as a nasal spray missed the co-primary endpoints of improving PSPRS and SEADL scores from baseline to week 52 vs. placebo. Davunetide also missed several secondary and exploratory endpoints, but Allon could not be reached for details. Davunetide was well tolerated. The company has an SPA from FDA for the trial. Allon said it plans to conduct further analysis of the trial to determine if there is any evidence of an effect or explanation for absence of an effect of davunetide. Additionally, the company said it will evaluate its strategic options going forward and will take immediate action to reduce its operating expenses, including a reduction in headcount. ...