Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) shares pushed higher to start the week after the company announced a critical update from the U.S. Food and Drug Administration (FDA).
In terms of the specifics, Diffusion Pharma announced that it has received an accelerated response from the FDA in regards to its Pre-Investigational New Drug (PIND) meeting request. The PIND was filed on April 27, seeking FDA guidance on the company’s proposed clinical development program for the use of trans sodium crocetinate (TSC) in COVID-19 patients displaying severe respiratory symptoms and low oxygen levels.
The accelerated response to the PIND meeting request recommended that the first U.S. TSC COVID-19 study employ a double-blinded, controlled, randomized clinical trial design. The FDA also recommended incorporating the drug remdesivir, which has been newly approved for emergency use, into TSC clinical trials as a component of standard of care for patients hospitalized with severe disease.
The FDA agreed with the safety and oxygenation marker endpoints proposed by the company for early trials of TSC in COVID-19 patients and suggested a range of potential functional outcomes that might be used as primary endpoints in possible later-stage trials supporting product approval.
David Kalergis, CEO of Diffusion Pharma, commented:
We are gratified that in their accelerated response to our PIND for studies of TSC in COVID-19 patients the FDA has suggested this randomized, blinded clinical trial design allowing oxygenation endpoints in our initial U.S. trial, rather than the smaller unblinded safety trial we had expected. This more robust first U.S. study is fully funded by existing Company resources, and, with FDA guidance now in hand, we intend to move forward quickly under current expedited FDA and hospital-specific policies. Meanwhile, we expect a June 2020 first patient enrollment for the European arm of our TSC COVID-19 program being conducted at the Romanian National Institute of Infectious Diseases. We further expect the European trial to provide first human data regarding TSC’s oxygenation-enhancing potential in this disease by the end of the summer.
Diffusion Pharmaceuticals stock traded up about 10% Tuesday morning to $1.37, in a 52-week range of $0.21 to $3.79. The consensus price target is $3.50.
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