A machine learning model that screened 1,482 compounds potentially effective for treating coronavirus disease 2019 (COVID-19) has ranked Innovation Pharma’s COVID-19 candidate brilacidin in the top 3% of compounds predicted to be most effective against the novel coronavirus.
Findings from this machine learning study suggest brilacidin, Innovation’s antibiotic drug candidate, demonstrates a promising ability to bind coronavirus proteins and inhibit replication of the severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2). In the announcement of the findings, Innovation explained that the predictive framework used in the machine learning model was constructed through the assessment of main protein structures in approximately 100 different viral organisms. This increased the generalizability of the model to multiple viruses.
Similar to the findings from this machine learning study, another independent peer-reviewed study that screened 11,552 compounds from investigational agents and drugs approved by the U.S. Food and Drug Administration also found that brilacidin held promising potential as an effective inhibitor of SARS-CoV-2.
Overall, Innovation believes these two studies support emerging and growing antiviral data to support the use of brilacidin as a treatment for COVID-19. The company has launched a randomized, placebo-controlled Phase II trial to study how well brilacidin works when given to hospitalized patients with moderate-to-severe COVID-19. In late February, Innovation said patients in the trial are currently being treated, while recruitment and enrollment remain ongoing.
The new multicenter trial plans to enroll up to 120 patients, all of whom will be randomly assigned in equal numbers to either brilacidin or placebo. Researchers will compare the two groups in terms of the time to sustained recovery through day 29. Other endpoints assessed throughout the trial include in-hospital outcomes, all-cause mortality, disease biomarkers and inflammation-related biomarkers, and SARS-CoV-2 viral load changes, among other measures.
“It is a rewarding moment for me, as one of the discoverers of brilacidin, to see brilacidin continue to receive validation as a promising antiviral treatment—based both on in silico molecular modeling studies and lab research,” said William F. DeGrado, Ph.D., Professor in the Department of Pharmaceutical Chemistry at University of California San Francisco (UCSF) and Innovation Pharma’s Scientific Advisor, in a statement. “COVID-19 is, in all likelihood, here to stay. Bringing to market effective coronavirus therapeutics with novel mechanisms less prone to drug resistance developing due to mutations, a characteristic brilacidin is exhibiting, will be important as the world combats this infectious and deadly virus.”
DeGrado added he looks forward to viewing how well brilacidin performs in the Phase II “trial in hospitalized COVID-19 patients and am hopeful brilacidin will emerge as an effective antiviral, with added beneficial immunomodulatory properties.”
Back in April 2020, Innovation announced it was discussing options with healthcare provider networks and hospitals in the U.S. and Europe concerning rapid advancement of brilacidin testing in human COVID-19 trials.
Since then, brilacidin received FDA Fast Track designation as a potential COVID-19 therapy. The agent represents one of only a few drugs targeting COVID-19 that has been studied in human trials for indications other than COVID-19. In addition, brilacidin has corresponding safety and efficacy data in more than 460 patients, which the company suggests could enable rapid approval for the treatment of COVID-19.
“Receiving Fast Track designation is an important acknowledgment of the results of our COVID-19 laboratory research,” said Innovation’s Chief Executive Officer, Leo Ehrlich, in a statement. “Fast Track designation is well-timed, as we anticipate starting our Phase 2 clinical trial in hospitalized COVID-19 patients this month and should help bring brilacidin to patients faster in these dire times.”
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