NeuroBo Pharmaceuticals Inc. (NASDAQ: NRBO) has announced the review of safety data by an independent Data Monitoring Committee for 36 patients that were treated in the company’s Phase 2/3 clinical study evaluating its lead candidate ANA001.
ANA001 trials to continue without modification
ANA001 is a novel oral niclosamide drug the company is developing as a possible COVID-19 treatment. Based on reviewed data, the DMC has recommended the trial continue without any modification.
A two-part Phase 2/3 multisite, double-blind, placebo-controlled trial is ongoing to examine ANA001’s tolerability, safety, and efficacy in the US. Patients with moderate to severe COVID-19 who do not require ventilators are given a seven-day dose of ANA001 (niclosamide capsules) plus standard-of-care treatment in both study phases. The trial’s Phase 2 portion is scheduled to enroll 60 patients, with the primary goal of determining tolerability and safety. The study’s secondary objectives include pharmacokinetics and efficacy measurements (median time to hospital discharge).
The trial’s Phase 3 phase is intended to enroll hundreds of patients, with a median time to hospital discharge, tolerability, and safety being the primary objectives. Secondary goals will assess clinical improvement as well as the requirement for and duration of rescue therapy.
NeuroBo to continue enrolment in Phase 2/3
CEO and President Richard Kang said, “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.”
