Relief Therapeutics' COVID-19 Treatment Candidate Cuts Hospital Stay Versus Placebo, Recovery From Respiratory Failure Yet To Be Determined - Relief Therapeutics (OTC:RLFTF)

Privately-held NeuroRx and Relief Therapeutics Holdings SA RLFTF have reported preliminary results from Phase 2b/3 trial evaluating aviptadil dubbed as Zyesami (previously RLF-100) in patients with respiratory failure due to critical COVID-19.
In the study, patients treated with Zyesami plus maximal standard of care were discharged earlier from hospital care than those treated with placebo plus maximal standard of care.
Among the secondary efficacy endpoints evaluated in patients treated with High Flow Nasal Cannula (HFNC) therapy and Mechanical Ventilation, there were six of eight comparisons favoring Zyesami, resulting in at least a three-day median difference in the hospital stay. The most significant difference was observed in those treated with HFNC who experienced 13 fewer days in the ICU (12 vs. 25) and eight fewer days in the hospital (15 vs. 23).
With the improvement in survival since the start of the pandemic, differences in survival were not seen at day 28, and patients are being followed through day 60. The study has not yet determined results for the stated primary endpoint of recovery from respiratory failure. Investigators are in the process of confirming the timing of each case of recovery from medical records, following which the study's investigators' committee will review each case before unblinded data analysis of this endpoint.
The company has launched a Phase 2/3 trial to explore inhaled use of Zyesami in patients who are not yet in respiratory failure. Further study of ZYESAMI's role in critical COVID-19 will be conducted under the BARDA and DOD Medical Countermeasures-funded I-SPY trial.
The most common side effects of Zyesami in the clinical trial were mild to moderate diarrhea (seen in 30% of Zyesami-treated vs. 1.5% of placebo-treated patients) and systemic hypotension (low blood pressure) seen in 31 Zyesami-treated patients vs. 25 placebo patients. Two deaths were reported, one in each group.
Price Action: RLFTF shares gained 18% at $0.63 in premarket trading on the last check Tuesday.

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