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Diffusion Pharma's Trans Sodium Crocetinate Associated With Improved Outcomes In COVID-19 Patients

05/10/2021 10:23
  • Diffusion Pharmaceuticals Inc (NASDAQ: DFFN) has announced final results from the Phase 1b study evaluating trans sodium crocetinate (TSC) in hospitalized COVID-19 patients.
  • Data from the open-label study were reviewed by an independent Safety Monitoring Committee (SMC).
  • Topline results based upon analyses of primary endpoint data from the trial were announced in February, indicating that TSC was safe and well-tolerated.
  • The Company and the SMC have concluded analyses of the trial's planned secondary and exploratory endpoints, which included time to improvement in WHO ordinal scale by day 7 and through day 29, time on oxygen supplementation, and hospital length of stay.
  • It was observed that patients receiving the 1.5 mg/kg dose had improved outcomes in these secondary and exploratory endpoints compared to those receiving lower doses.
  • In addition, no patients required dialysis or developed acute kidney injury, and there were no reports of pulmonary embolism or deep vein thrombosis. One death was reported during the study of a patient who received the lowest dose, which the SMC determined to be not drug-related.
  • Diffusion has initiated a series of three short-term Oxygenation Trials in the U.S. in 2021, funded with cash-on-hand.
  • The first of these studies, the TCOM Trial, tested TSC at doses up to 2.5 mg/kg. Trial data will be completed and announced by the end of the second quarter of 2021.
  • Diffusion anticipates initiating and completing the other two short-term Oxygenation Trials in the second half of 2021, with topline results from each study available within two months of their respective completion.
  • Price Action: DFFN shares are up 0.25% at $0.68 on the last check Monday.