Benzinga | Jul 27, 2020 08:04AM EDT

Diffusion Pharmaceuticals Receives FDA Guidance For International Phase 1b/2b COVID-19 Clinical Program With TSC; Says Guidance Being Incorporated Into Global Study Protocol, Enrollment Of First Patient Now Expected In August

Guidance being incorporated into global study protocol

Enrollment of first patient now expected in August

CHARLOTTESVILLE, Va., July 27, 2020 (GLOBE NEWSWIRE) -- Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN) ("Diffusion" or "Company"), a biotechnology company developing novel therapeutics for the treatment of unmet medical needs, today announced receipt of guidance from the U.S. Food and Drug Administration (FDA) on the Company's recently-filed Investigational New Drug (IND) application for trans sodium crocetinate (TSC) in COVID-19 patients. This guidance suggests certain study design changes with regard to endpoints and statistical considerations that Diffusion believes will enhance the prospect of regulatory approvals upon program completion, should the clinical results be favorable.

Because these changes will be harmonized throughout the overall TSC global development program, they are being submitted for clearance by the Romanian National Agency for Medicines and Medical Devices (NAMMD). NAMMD has regulatory oversight over the Company's first planned clinical trial, an open-label Phase 1b lead-in trial in 24 hospitalized COVID-19 patients at the Romanian National Institute of Infectious Diseases (NIID).

The Company previously announced expectations that the first patient would be enrolled in the Phase 1b study by the end of July. Considering the FDA's suggested protocol modifications and an additional NAMMD review cycle, the Company now expects the first patient will be enrolled by the end of August, with first data available early in the fourth quarter of 2020.

"Getting the clinical trial protocol right is imperative as it will support regulatory reviews and determinations," said David Kalergis, chief executive officer of Diffusion. "We are grateful for the FDA's guidance. Incorporating their views into the Romanian arm of the program will delay the program start by just a few weeks, yet should have no material impact on overall program timelines."