WAKEFIELD, MA / June 23, 2022 / ACCESSWIRE Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today reported that Brilacidin, the Company’s defensin-mimetic drug candidate exhibiting broad-spectrum antiviral activity, inhibited the Omicron (B.1.1.529) and Delta (B.1.617.2) variants of SARS-CoV-2 based on in vitro testing conducted in collaboration with National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID) scientists. Researchers at Rutgers University have also shown Brilacidin inhibited in vitro the Gamma (P.1) and Alpha (B.1.1.7) variants of SARS-CoV-2.
Brilacidin has now been tested in vitro in seven SARS-CoV-2 strains (Omicron, Delta, Gamma, Alpha, Italian, Washington, Wuhan) and three human coronavirus (H-CoV) strains (OC43, 229E, and NL63), in addition to MERS-CoV and SARS-CoV-1. Brilacidin has consistently inhibited all coronaviruses tested, independent of cell type, at generally attainable systemic concentrations (based on established human pharmacokinetics of IV-administered Brilacidin).
Identifying COVID-19 countermeasures with novel mechanisms of action is vital. SARS-CoV-2 continues to evolve at an accelerated pace, raising questions as to what the dominant variant (or sub-variant) may be this fall and winter, when infections often spike -- and if today’s COVID-19 vaccines and therapeutics can maintain their effectiveness.
Emerging SARS-CoV-2 variants, and increasingly their sub-variants, contain immunity-evading mutations. These mutations alter key parts of the SARS-CoV-2 spike protein that attach to human cells, making the virus more transmissible and potentially more virulent. Unlike other antivirals, such as monoclonal antibodies, and most vaccines, Brilacidin has been shown not to target the Spike S1 and Spike RBD regions of SARS-CoV-2, acting instead through dual-acting neutralizing and blocking antiviral properties, able to target virus and host. These antiviral traits support Brilacidin’s ability to maintain its anti-coronavirus activity and suggest Brilacidin would be less subject to resistance.
Related, results from new NIH/NIAID in vitro testing of Brilacidin in over 20 acutely infectious viruses, and from the Brilacidin Phase 2 COVID-19 clinical trial, are being prepared for publication. Findings from the Rutgers’ Brilacidin research can be accessed at the link below1 and build on earlier published Brilacidin research conducted by scientists at George Mason University and at University of Arizona and University of California-San Francisco.
In 2021, the Company completed a Phase 2 clinical trial of Brilacidin (NCT04784897) for treatment of moderate-to-severe COVID-19 patients. While the trial did not meet its primary endpoint in reducing time to sustained recovery through day 29, certain patient subgroups did show treatment benefits of Brilacidin for that primary endpoint. For example, patients treated early from onset of symptoms achieved sustained recovery more quickly (Brilacidin 5-dose group vs pooled placebo, p=0.03). To date, only a modicum of success has been demonstrated by any company conducting clinical trials in moderate-to-severe hospitalized cases of COVID-19. A possible reason for this may be owing to frequent changes in the standard of care with patients receiving a cocktail of fluctuating concomitant medications, which complicates the interpretation of the clinical trial data and that of the new drug candidate being evaluated. Clinical observations of COVID-19 patients treated with Brilacidin further lead us to believe that higher and more frequent dosing of Brilacidin may be more appropriate to tackle this complex disease in the hospital setting.
Taken together, the results from NIH/NIAID testing of Brilacidin are supportive of previously completed research and give the Company confidence in the compound’s antiviral potential. The Company remains active in pursuing additional government-based funding opportunities, as well as licensing partnerships, to advance Brilacidin in the highly attractive area of developing novel broad-spectrum medicines for treating viral diseases.
1Theresa L Chang, et al. “Brilacidin, a Non-Peptide Defensin-Mimetic Molecule, Inhibits SARS-CoV-2 Infection by Blocking Viral Entry.” EC Microbiol. 2022 Apr; 18(4):1-12.