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Thursday, September 23, 2021 10:17:12 AM
WAKEFIELD, MA / September 23, 2021 / ACCESSWIRE Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today provided an update on the status of its randomized, double-blind, placebo-controlled Phase 2 clinical trial of Brilacidin for the treatment of moderate-to-severe COVID-19 in hospitalized patients (see NCT04784897), as well as related news.
Based on information received from the data management and biostatistics vendors, study unblinding, analysis of the unblinded data and release of topline study results for the Brilacidin COVID-19 trial is anticipated to occur in mid-to-late October. The Company looks forward to the data to learn if Brilacidin’s multiple properties translate into meaningful clinical results, given the unmet need for COVID-19 therapeutics and ongoing pandemic.
In related news, the Company has received individual patient Expanded Access (compassionate use) requests for Brilacidin to treat critically ill COVID-19 patients who are not responding to prior therapy. Expanded Access was implemented by the FDA and Congress to address physician applications for access to potentially lifesaving drugs, prior to FDA approval, for patients in their care when available treatment options have failed. Following receipt of such requests, the Company has supplied Brilacidin to relevant hospitals for individual patient use, with the FDA granting the treating physician permission for the emergency administration of Brilacidin. In addition to Brilacidin’s antiviral profile, Brilacidin’s immunomodulatory and anti-inflammatory properties may be particularly beneficial in treating COVID-19 in hospitalized patients.
For more details on the Company's Expanded Access policy, please visit:
https://www.ipharminc.com/expanded-access-and-compassionate-use
Brilacidin in vitro antiviral research remains ongoing at multiple universities. New preliminary data from one academic laboratory show Brilacidin is active against adenoviruses—a non-enveloped virus—complementing earlier data showing potent Brilacidin inhibition of different strains of coronaviruses, alphaviruses and bunyaviruses (enveloped viruses). A paper from this lab on Brilacidin’s broad-spectrum antiviral effect in multiple virus families is being prepared. Separate scientific papers also are underway from two other academic research groups supporting Brilacidin’s antiviral properties and providing insight into Brilacidin’s mechanisms of action.
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