- Diffusion Pharmaceuticals (NASDAQ:DFFN) jumps 18% premarket in reaction to the announcement of completion and reporting topline data from Phase 1b clinical trial of its novel, trans sodium crocetinate (TSC), in hospitalized COVID-19 patients with confirmed hypoxemia.
- The primary objective was to evaluate the safety and tolerability of TSC administered on a more frequent dosing regimen not previously tested in a clinical trial setting.
- No dose-limiting toxicities or serious adverse events were observed in the final, 1.5 mg/kg dose, which is consistent with the safety data from other dose cohorts.
- Evaluation of secondary endpoint data is ongoing and will be available early in Q2.
- Also, the company plans two additional studies to evaluate the efficacy of TSC on both ends of oxygen’s complete journey through the body, from improving uptake in the lungs to enhancing delivery from the microcirculation into tissue.
- The first study (“TCOM Study”) will measure the effects of TSC on peripheral tissue oxygen delivery using a device called a transcutaneous oximeter, or TCOM. Study initiation is expected by the end of Q1 and completion in Q2, with topline data within one to two months following completion.
- The second study (“DLCO Study”) will measure the effects of TSC on the ability of the lungs to transfer gas from inspired air to the bloodstream, using carbon monoxide as a surrogate for oxygen.
- Diffusion plans to commence the DLCO Study in Q2 and complete it in Q3; topline results should be available within one to two months of study completion and will inform the company’s ongoing TSC development plan.