- NRx Pharmaceuticals Inc NRXP has announced positive data from its Zyesami (Aviptadil) Expanded Access Protocol (EAP) in patients with critical COVID-19 and respiratory failure.
- Overall, patients receiving at least one dose of Zyesami in addition to intensive care were alive at 28 days.
- This EAP includes sick patients for whom no other options were available and could not enroll in a study due to additional risk factors.
- Among patients receiving maximal intensive (i.e., non-palliative) care, 76% of those treated with high nasal flow cannula (HFNC) were discharged from the hospital or were alive and in the hospital at day 28, compared to 54% of those treated with mechanical ventilation.
- Treatment-related adverse events from this EAP are congruent with those seen in the randomized controlled phase 2b/3 clinical trial of Zyesami. Treatment-related adverse events included diarrhea (5%) and hypotension (5%). Other adverse events included tachycardia and flushing.
- The EAP data are being provided to FDA as "real-world data" in support of the findings from the Zyesami randomized controlled phase 2b/3 clinical trial.
- Price Action: NRXP shares are up 12.5% at $20.25 during the premarket session on the last check Tuesday.
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