DiaMedica believes, based on the FDA's feedback, that the previously completed rat reproductive toxicity study may be acceptable to support a U.S. investigational new drug (IND) application, provided that DiaMedica can demonstrate sufficient evidence of DM199 exposure and enzymatic activity throughout the previous completed rat 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) (drug exposure) and pharmacologic activity study of DM199 in rats and is summarizing the 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 FDA for review.

"We appreciate the FDA's feedback and we look forward to completing these non-clinical studies to ultimately support filing of a U.S. IND filing, while we initiate our PE study in Canada and the United Kingdom later this year," said Dr. Julie Krop, DiaMedica's Chief Medical Officer.