Oxidien Pharmaceuticals Announces Favorable Response from FDA on Proposed Development Plan
UF Innovate | The Hub resident client Oxidien Pharmaceuticals, a clinical-stage biopharmaceutical company developing a best-in-class enzyme therapeutic for secondary hyperoxaluria, announced that it has received encouraging responses from the 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 results from a prospective, randomized, double-blind, placebo-controlled healthy volunteer study evaluating both safety and efficacy. The official record of the meeting detailed the FDA’s requirements around the development plan (nonclinical and Phase 1/2) and confirmed that the proposed clinical end-points, as well as the general trial design, were reasonable.
“We are very pleased with the outcome of this interaction and appreciate the guidance from the agency,” said Helena Cowley, CEO of Oxidien Pharmaceuticals.
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