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.
"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," stated Richard J. Kang, Ph.D., President and Chief Executive Officer of NeuroBo. "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."
For more information on this clinical trial, please visit: www.clinicaltrials.gov, NCT04603924
About Niclosamide and ANA001
ANA001 is a proprietary oral niclosamide formulation in development as a treatment for patients with COVID-19. Niclosamide has antiviral and anti-inflammatory properties, and a well-understood safety profile in humans. ANA001 is currently being studied in a 60-subject Phase 2 clinical trial conducted in the U.S. Niclosamide has demonstrated both antiviral and immunomodulatory activity with possible downstream effects on coagulation abnormalities observed in COVID-19. In preclinical research by an independent academic group published in Antimicrobial Agents and Chemotherapy, niclosamide inhibited viral replication in vitro and was more potent than remdesivir in the same assay.
Additional in vitro studies have shown that niclosamide prevents replication of SARS-CoV-2 at very low concentrations and that the compound appears to exhibit three distinct mechanisms of action: 1) acting as a potent antiviral against a variety of other viruses including influenza; 2) reducing inflammation without suppressing the immune system; and 3) providing bronchodilation, which is a useful pulmonary mechanism for at-risk patients with underlying pulmonary and/or cardiovascular conditions.
As a result, the company believes ANA001 has the potential to reduce viral load and inflammation associated with cytokine dysregulation, acute respiratory distress syndrome (ARDS), and coagulation abnormalities and thus improve time to clinical improvement defined as hospital discharge recorded using the WHO Ordinal Scale for Clinical Improvement.
The company believes ANA001 has distinct competitive advantages in this market, including (1) offering an effective treatment for COVID-19; (2) having 3+ year marketing exclusivity in the U.S. upon U.S. Food and Drug Administration (FDA) approval; (3) providing ease of administration via a capsule formulation and potential to dramatically lower overall t...
(All Rights Reserved)