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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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