Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN) Incorporates Guidance from the FDA into the Global Phase 1b/2b COVID-19 Clinical Study with TSC

A majority of patients with COVID-19 respiratory tract infections suffer from impaired oxygen levels. However, according to Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN) and its affiliated researchers, the oxygen levels can be enhanced through a mechanism of action from trans sodium crocetinate (TSC). This is the company’s newest candidate for hospitalized COVID-19 patients and those displaying critical respiratory symptoms.

Diffusion has since filed an Investigational New Drug (IND) application for TSC and has received massive guidance from the FDA, which will guide the anticipated study. The exclusive guidance will help the company incorporate necessary changes concerning endpoints and statistical considerations. However, the changes must be cleared and endorsed by the Romanian National Agency for Medicines and Medical Devices (NAMMD).

Getting the Clinical Trial Procedure Right Is Important

Diffusion is aware that hundreds of people suffer from life-threatening medical conditions, including failure of multiple organs due to respiratory distress. In a majority of the severe diseases, the primary obstacles are usually lack of enough oxygen.

The company was anticipating to enroll the first patient for the Phase 1b study in July. This was not the case, though, because it had to incorporate the FDA’s suggested modifications as well as an additional review cycle from NAMMD. Getting the clinical trial procedures is imperative, according to the CEO of Diffusion David Kalergis, but after all the incorporations, they are ready to enroll the first patient by the end of August.

The Development of TSC Was a Combined Effort

Evolutions in research have escalated Diffusion’s drive into offering tangible solutions with new treatments. The success of TSC may not have succeeded if the company had chosen to take the journey independently.

They engaged the U.S. Office of Naval Research, which was also interested in treatments for multiple organ failure.

Partnership and collaborations have proven to be powerful platforms of steering companies to success. Diffusion has also taken on a partnership with other US-bases institutions to expedite research programs in the development of TSC.

Meanwhile, the company has put its Phase 3 INTACT program on hold to focus and direct more of its resources on the COVID-19 pandemic.