DiaMedica Therapeutics Inc. has received a written response from the U.S. Food and Drug Administration (FDA) regarding the need for additional nonclinical reproductive toxicity data to support continued development of DM199 (rinvecalinase alfa) for the treatment of preeclampsia. The company believes that, based on the FDA's feedback, the previously completed rat reproductive toxicity study may be acceptable to support a U.S. investigational new drug (IND) application. This acceptance is contingent upon DiaMedica demonstrating sufficient evidence of DM199 exposure and enzymatic activity throughout the previous study, as well as adequate pharmacologic effect in rats to support their use as an appropriate toxicology species.

To address the FDA's request, DiaMedica is initiating a pharmacokinetic (PK) and pharmacologic activity study of DM199 in rats. The company is also summarizing recently completed study data intended to support the pharmacodynamic activity of DM199 in this species. Upon completion of the rat PK study, DiaMedica plans to submit the requested information to the FDA for review.

Development Plans

Dr. Julie Krop, Chief Medical Officer of DiaMedica, stated that the company appreciates the FDA's feedback and looks forward to completing these non-clinical studies. The goal is to support the filing of a U.S. IND application. Concurrently, DiaMedica plans to initiate its preeclampsia study in Canada and the United Kingdom later this year.

About DM199

DM199 (rinvecalinase alfa) is a recombinant form of human tissue kallikrein-1 (rhKLK1) in clinical development for preeclampsia, fetal growth restriction, and acute ischemic stroke. KLK1 is a serine protease enzyme that plays a role in the regulation of diverse physiological processes via a molecular mechanism that increases production of nitric oxide, prostacyclin, and endothelium-derived hyperpolarizing factor.