Initiating ReMEDy2 – Pivotal Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study
DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical Company focused on developing novel treatments for neurological disorders and kidney diseases, announced today that the U.S. Food & Drug Administration (FDA) has accepted the Company’s Investigational New Drug (IND) application. The Company plans to proceed with a pivotal Phase 2/3 study of DM199 (recombinant human tissue kallikrein-1or KLK1) for the treatment of patients with Acute Ischemic Stroke (AIS).
The upcoming ReMEDy2 Trial follows the Phase 2 study in AIS patients that demonstrated an improvement in stroke outcomes and reduction in stroke recurrence, along with an excellent safety profile. The findings are consistent with a significant body of clinical evidence from the use of the approved urinary-sourced KLK1 (Kailikang®) in China. The upcoming pivotal ReMEDy2 trial will evaluate whether DM199, a recombinant investigational agent, can improve three-month outcomes in AIS patients without other treatment options.
https://finance.yahoo.com/news/diamedica-therapeutics-announces-fda-clearance-125400319.html
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.