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Thursday, April 22, 2021 4:59:50 AM
Apr. 22, 2021 2:18 AM ETRelief Therapeutics Holding AG (RLFTF)By: Mamta Mayani, SA News Editor
Relief Therapeutics (OTCQB:RLFTF) and AdVita Lifescience announce that the first patient is expected to be enrolled next week in a Phase 2 trial evaluating the inhaled formulation of RLF-100 for the prevention of COVID-19-related acute respiratory distress syndrome (ARDS).
The trial is expected to enroll 80 patients, who will receive either RLF-100 together with standard of care or placebo plus standard of care.
The primary endpoint is the time (in days) from hospitalization to clinical improvement, up to day 28. Clinical improvement shall be defined as either alive hospital discharge or a decrease of two or more points on the WHO-recommended nine-point ordinal scale of clinical status. Study is expected to take approx. 6-12 months to complete.
In addition, the company is currently preparing a European Phase 2b/3 study with IV RLF-100 in COVID-19 patients.
Clinical development of IV RLF-100 in non-COVID-19-induced ARDS is also under consideration.
Relief also plans to initiate a Phase 2 dose-finding study with inhaled RLF-100 in pulmonary sarcoidosis in Europe in H2.
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