- The stock price of Neurobo Pharmaceuticals Inc (NASDAQ: NRBO) increased by over 6% yesterday. This is why it happened.
The stock price of 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 – increased by over 6% yesterday. Investors are responding positively to announcing 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. And 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. And 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. And secondary objectives will evaluate clinical improvement and the need and duration for rescue therapy.
“The DMC’s recommendation to continue enrollment of the Phase 2/3 clinical trial, without modification, is an important milestone for our lead drug candidate, ANA001, as a potential treatment for COVID-19. We look forward to continuing the development of this potentially life-saving therapy to address the ongoing need for safe and effective COVID-19 treatments, particularly as this pandemic is evolving into an endemic. We expect to complete the Phase 2 portion of the trial in the fourth quarter of this year and to achieve a number of value-creating milestones with this program in the coming months, including initiation of the Phase 3 of trial.”
— Richard J. Kang, Ph.D., President and Chief Executive Officer of NeuroBo
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