- Diffusion Pharmaceuticals Inc 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.
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