Innovation Pharmaceuticals
Candidate: Brilacidin
Category: ,
Types: Vaccine and antiviral small molecule drug formulations against COVID-19 containing Defensin mimetic. The drug is in Phase II development in oral muscositis in head and neck cancer
Status: Innovation on April 27 said testing of Brilacidin in COVID-19 was set to begin the week of May 4, based on results from initial tests at an undisclosed U.S. Regional Biocontainment Laboratory (RBL) showing that Brilacidin had antiviral activity against SARS-CoV-2 in Vero cells. The company said it was prioritizing Brilacidin’s clinical development by moving to rapidly advance Brilacidin testing in human trials, including preparations for engaging with regulators.
Further research studies to be conducted at the RBL, Innovation said, include testing Brilacidin’s direct virucidal activity on SARS-CoV-2 in human lung epithelial cells; obtaining the in vitro concentration of Brilacidin that gives half-maximal response (EC50 value) in lung epithelial cells; determining impact of multiple dose exposure of Brilacidin on SARS-CoV-2; evaluating time-to-treatment windows as a post-exposure therapeutic; and exploring if Brilacidin has synergistic properties with other small molecules that have antiviral activity.
A week earlier, Innovation announced publication of a preprint study in ChemRxiv by researchers from Argentina’s Universidad Austral identifying Brilacidin as one of 12 most promising potential inhibitors of SARS-CoV-2, based on molecular screening of 11,552 compounds.
Also in April, Innovation disclosed it was in talks with health care provider networks and hospitals in the U.S. and Europe to “rapidly” advance Brilacidin testing into human trials, and announced a study published in the International Journal of Infectious Diseases supporting Brilacidin’s direct inhibition of SARS-CoV-2, based on testing on Vero cells. According to Innovation, the antiviral activity showed Brilacidin’s 3-in-1 therapeutic potential—antiviral, anti-inflammatory, antimicrobial—against COVID-19 and associated complications. In other indications, the company said, Brilacidin has shown the ability to inhibit interleukin-6 (IL-6) and other pro-inflammatory cytokines and chemokines identified as key drivers in worsening prognoses of COVID-19 patients.
Innovation said in March it was studying Brilacidin as a vaccine independent of the small molecule drug studies involving the RBL.In February, Innovation stated that it submitted a Material Transfer Agreement with a “leading U.S.-based virology laboratory” to study Brilacidin for SARS-CoV-2. If lab tests prove successful, Innovation said, it will expedite research and clinical development of Brilacidin “via pharmaceutical partnerships, academic collaborations and government grants.” Innovation has also submitted a preliminary summary of Brilacidin’s potential for treating coronavirus to the Biomedical Advanced Research and Development Authority (BARDA).
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types:
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