Dec 19, 2019: Oxidien Pharmaceuticals, announced that it has received encouraging responses from U.S. Food and Drug Administration (FDA) regarding their proposed Phase 1/2 trial in secondary hyperoxaluria patients and other development plans for its lead drug candidate.
The FDA reviewed Oxidien’s IND enabling pre-clinical data, and the results from a prospective, randomized, double-blind, placebo-controlled healthy volunteer study that evaluates both safety and efficacy.
Before this year, Oxidien Pharmaceuticals, LLC, spun out the hyperoxaluria research division from Captozyme Inc., a microbiome contract development and the manufacturing organization.
Having raised a total of $5.7 million to support the development of novel oxalate-reducing enzymes, Captozyme recognized a solid foundation of data enabling a knowledgeable clinical program.
https://fda.einnews.com/pr_news/505257241/oxidien-pharmaceuticals-announces-favorable-response-from-fda-on-proposed-development-plan
