- A proprietary oral formulation of niclosamide that is a potential oral antiviral and anti-inflammatory agent with a long history of use and a well-understood safety profile in humans
- In Phase 2/3 development as a treatment for patients with moderate to severe COVID-19 (patients not requiring ventilators)
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.
Acts as a potent antiviral to a broad homology of other viruses including influenza
Reduces inflammation without suppressing the immune system
Provides bronchodilation, a useful pulmonary mechanism for at-risk patients with underlying CV and/or pulmonary conditions
Niclosamide has demonstrated both antiviral and anti-inflammatory 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.
ANA001 has the potential to reduce the 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.
ANA001 may have distinct competitive advantages in this market, including (1) offering an effective treatment for moderate to severe COVID-19 (patients not requiring ventilators); (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 treatment cost; and (4) possessing a proven safety profile (generic niclosamide has been used safely for 50 years as a treatment for tapeworm infections).