Diffusion Pharmaceuticals expands clinical trial program of TSC for the treatment of COVID-19 Patients to include the Romanian National Institute of Infectious Diseases

CHARLOTTESVILLE, Va., May 20, 2020 (GLOBE NEWSWIRE) — Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) (“Diffusion” or “the Company”), a cutting-edge biotechnology company developing new treatments for life-threatening medical conditions by improving the body’s ability to deliver oxygen to the areas where it is needed most, today announced that it has entered into an agreement with the Romanian National Institute of Infectious Diseases (NIID) to begin a clinical trial program to test Diffusion’s lead drug trans sodium crocetinate (TSC) for the treatment of hospitalized COVID-19 patients presenting with lowered blood oxygen levels, a condition known as hypoxemia. Noted infectious disease researcher Prof. Adrian Streinu-Cercel, M.D., Ph.D., General Manager of the NIID, will serve as Principal Investigator.

Conduct of this clinical trial in Romania will be facilitated by ARENSIA Exploratory Medicine GmbH, a Germany-based contract research organization with dedicated state-of-the-art clinical research facilities located throughout Eastern Europe, including within the NIID.

Patients with COVID-19 and other severe respiratory tract infections often present with hypoxemia. Diffusion and its affiliated researchers believe the oxygen-enhancing mechanism of action of TSC could benefit COVID-19 patients by mitigating the multiple organ failure that often results from hypoxemia associated with Acute Respiratory Distress Syndrome (ARDS), a leading cause of death in COVID-19 patients.

The NIID trial is planned to be conducted in two phases, with a possible third to follow. The first trial, which is fully funded by existing Diffusion resources, is a Phase 1 open-label, pharmacokinetic/pharmacodynamic, ascending-dose safety lead-in trial in 24 hospitalized hypoxemic COVID-19 patients. In addition to collecting safety and tolerability data, study endpoints will include arterial blood gas analysis and pulse oximetry measurement. This trial is expected to be completed in the third quarter of 2020.  These data are intended to provide proof-of-concept for the use of TSC in enhancing oxygenation of hypoxemic patients with severe respiratory infections, like COVID-19. Assuming positive results, Diffusion intends to promptly commence a follow-on trial, also fully funded by existing Diffusion resources, in approximately 100 patients at an expanded number of study sites in Europe. This follow-on trial will be a placebo-controlled, double-blinded, safety and efficacy study of TSC in hypoxemic COVID-19 patients. Depending upon the results, a third phase, designed with a view to regulatory approval in Europe, may then be conducted.

Commencement of the NIID program is expected to be facilitated by a special Romanian regulatory authority initiative for COVID-19 clinical trials that reduces regulatory approval times from 60 days down to seven days from the time of program submission, which is targeted for the end of May 2020. NIID is the largest provider of treatment for COVID-19 patients in Romania. NIID sources report that about 500 patients with COVID-19 are currently hospitalized in its facility, with about 50 in intensive care.

As previously reported, Diffusion also is preparing for U.S-based clinical trials of TSC for the treatment of hypoxemia in patients with severe respiratory infections, including COVID-19, which will be conducted largely in parallel to NIID trials. This arm of the Company’s respiratory distress-related hypoxemia program is being pursued in partnership with the University of Virginia and other leading U.S.-based research centers. A pre-IND submission is currently under review by the U.S. Food and Drug Administration (FDA) with a response expected before the end of this month.

“We at the National Institute of Infectious Diseases are expediting our collaboration with Diffusion Pharmaceuticals to test TSC’s novel oxygenation-enhancing mechanism of action to treat ARDS in patients with COVID-19,” said Prof. Streinu-Cercel. “Given the shortened response times for regulatory approvals and the immediate availability of patients, we expect timely enrollment and prompt completion of the first phase of this study.”

“We welcome the addition of Prof. Streinu-Cercel and the NIID to the growing ranks of researchers seeking to investigate TSC for use in COVID-19 patients,” said David Kalergis, chief executive officer of Diffusion. “We believe that the combination of high-quality research facilities, streamlined regulatory policies and a large patient pool will expedite the assessment of TSC’s effect in treating hypoxemia related to severe respiratory infections, including COVID-19. We are also hopeful to soon get the go-ahead from the U.S. FDA to submit an IND to allow the commencement of clinical development in the United States.”

TSC is in clinical development by the Company for the treatment of other conditions related to low-oxygen levels including the treatment of acute stroke and glioblastoma multiforme (GBM) brain cancer. Preclinical data indicate TSC increases oxygen availability and provides a functional benefit in animal models of acute lung injury and hemorrhagic shock. Clinical data from 150 patients receiving TSC for other indications demonstrate that the drug has an acceptable human safety profile in both healthy and critically ill patients.