Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN) has reported results for the three months and nine months ended September 30, 2020, and also offered updates on the development of trans sodium crocetinate(TSC), its lead product candidate.
The company is developing TSC to enhance oxygen diffusion to tissues experiencing hypoxia or low oxygen levels. Hypoxia is a severe complication common in most difficult-to-treat and intractable conditions.
In the third quarter, the company enhanced its management team following the appointment of Robert Cobuzzi as the CEO and president, Jane Hollingsworth, as a director, and Chris Galloway as the company’s Chief Medical Officer.
Diffusion dosed first patients in TSC study
During the quarter, the company also dosed the first two patients in the Phase 1b clinical study evaluating TSC in COVID-19 patients. The study’s primary endpoint is safety and tolerability of TSC in hospitalized patients administered after every six hours for 15 days. The company has used this dosing regimen more frequently in its past clinical studies. Enrolment in the study is ongoing, and so far, there are no dose-limiting toxicities reported.
The company expects to accomplish optimal clinical dose and TSC dosing frequency before modifying the program in the near-term. Diffusion will evaluate TSC in clinical models to ascertain proof of concept for improving oxygenation after TSC administration. The company will evaluate the possibility of expanding the trial with more doses on the same regimen. More details regarding the expanded 100-303 COVID Studies design will be available in January 2021, with commencement expected in Q1 2021.
Diffusion has adequate cash to fund TSC studies
The company’s CEO Robert Cobuzzi said that the company had experienced significant changes in recent months as it continues to refine its vision. He said they are delighted with the progress in Q3 2020, and Diffusion is planning to implement its plans in the coming months. He said that they expect the near-term strategy to boost the chances of TSC development success.
Diffusion ended the quarter with $21 million in cash and cash equivalents, which is enough to fund the current TSC studies.