Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN) has announced that the FDA has granted it accelerated response regarding its pre-investigational New Drug meeting request.
FDA gives Diffusion accelerated response on TSC trial
The company had filed PIND request with the FDA on April 27, seeking guidance on a clinical development program that will use trans sodium crocetinate in coronavirus patients experiencing low oxygen levels and severe respiratory signs. The company’s first TSC coronavirus study employ a randomized, controlled, double-blind clinical study design to address the broad unpredictability in the standard of care because of the fast-changing coronavirus experience.
Also, the FDA that, if possible, remdesivir should be incorporated in the TSC study considering it has been approved for emergency use. It should be employed as a standard of care component in hospitalized patients with severe symptoms of the disease. The agency agreed with the oxygenation marker and safety endpoints proposed by Diffusion Pharmaceuticals for early TSC trials in patients with COVID-19. Similarly, it suggested various possible fictional outcomes that might be employed as primary endpoints in the late-stage study to support the product’s approval.
Diffusion to carry TSC study in Romani With NIID
Recently the company and Romanian National Institute of Infectious Diseases signed an agreement to initiate a clinical study program to test TSC as a treatment for hospitalized coronavirus patients exhibiting hypoxemia, low blood oxygen levels. NIID’s general manager and infectious disease expert, Prof Adrian Streinu-Cercel, will be the Principal Investigator in the study.
German-based research organization ARENSIA Exploratory Medicine GmbH will facilitate the carrying of the study in Romania. ARENSIA has ultramodern research facilities across Eastern Europe, which includes NIID. The NIID trial will be carried in two phases, and a third phase is likely to follow. Diffusion Pharmaceuticals will fund the first phase of the trial-testing pharmacokinetics of TSC in hospitalized patients, and endpoints will be safe and tolerable. The trial endpoints will also include pulse oximetry measurement and arterial blood gas analysis. The study will be completed in Q3 2020.