Committee Advises Continuation of Trial Without Modification
NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on developing and commercializing multimodal disease-modifying therapies for viral, neuropathic and neurodegenerative diseases, today announced that an independent Data Monitoring Committee (DMC) reviewed safety data from 36 patients treated in the Phase 2/3 clinical trial of NeuroBo's lead drug candidate, ANA001, a proprietary oral niclosamide formulation being developed as a potential treatment for COVID-19. Based on those findings, the DMC recommended the continuation of the trial without modification.
The two-part Phase 2/3 multi-center, double blind, placebo-controlled study to assess safety, tolerability, and efficacy of ANA001 is being conducted in the U.S. In both phases of the study, hospitalized patients with moderate to severe COVID-19 (patients not requiring ventilators) receive a seven-day course of ANA001 (niclosamide capsules) in addition to standard-of-care treatment. The Phase 2 part of the trial is expected to enroll 60 patients and the primary objective is to assess safety and tolerability. Secondary objectives include measurements of efficacy (median time to hospital discharge) and pharmacokinetics (PK).
The Phase 3 part of the trial is expected to enroll several hundred patients, with the primary endpoints being median time to hospital discharge, safety and tolerability. Secondary objectives will evaluate clinical improvement and the need and duration for rescue therapy.
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