{"id":451892,"date":"2021-03-05T11:34:31","date_gmt":"2021-03-05T16:34:31","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=451892"},"modified":"2021-03-05T11:34:31","modified_gmt":"2021-03-05T16:34:31","slug":"recruitment-and-enrollment-underway-at-eight-sites-for-innovation-pharmas-phase-2-clinical-trial-of-brilacidin-for-covid-19","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/recruitment-and-enrollment-underway-at-eight-sites-for-innovation-pharmas-phase-2-clinical-trial-of-brilacidin-for-covid-19\/","title":{"rendered":"Recruitment and Enrollment Underway at Eight Sites for Innovation Pharma\u2019s Phase 2 Clinical Trial of Brilacidin for COVID-19"},"content":{"rendered":"
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WAKEFIELD, Mass., March 05, 2021 (GLOBE NEWSWIRE) — Innovation Pharmaceuticals (OTCQB:IPIX) (\u201cthe Company\u201d), a clinical stage biopharmaceutical company, today reports that eight sites are now participating in the Company\u2019s international Phase 2 clinical trial assessing Brilacidin as a novel therapeutic in hospitalized patients with COVID-19.<\/p>\n

The trial is now posted on clinicaltrials.gov (https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04784897<\/a>), which shows seven sites as recruiting and enrolling patients. An eighth site is also now enrolling in addition, and the Company has informed\u00a0clinicaltrials.gov\u00a0of the change in status. Fifteen patients have already been dosed in the trial. More sites are coming online, which is expected to further accelerate enrollment and treatment.\u00a0<\/p>\n

The trial doesn\u2019t exclude any variants of SARS-CoV-2, the virus responsible for COVID-19. Virulent coronavirus strains have scoured different countries around the world recently, including highly contagious versions, such as P1 and B.1.1.7. Brazil this week reported that COVID -19 daily deaths reached a new high due to P1<\/a>. According to Russian news agency Tass<\/a>, nearly 1,500 coronavirus mutations have been discovered in Russia, a country where seven sites are currently enrolling patients in the Company\u2019s COVID-19 clinical trial. The Company is interested to see what information, if any, might be gleaned from the trial regarding variants considering laboratory studies have indicated Brilacidin to have strong pan-coronavirus treatment potential, remaining unaffected by viral mutations.<\/p>\n

\u201cWe are pleased to see patient recruitment and enrollment in our Brilacidin for COVID-19 clinical trial ramping up,\u201d said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. \u201cCOVID-19 is making a resurgence worldwide, with cases up 9 percent last week in Europe and cases no longer decreasing in the United States. Emerging variants are likely partially to blame for this rise. With its unique three-in-one therapeutic profile\u2014antiviral, anti-inflammatory and antibacterial\u2014we believe Brilacidin can play an important role in treating COVID-19. A broad-spectrum therapeutic that can be shown to inhibit coronaviruses would be a valuable countermeasure in fighting coronavirus disease and other viral outbreaks, now and in the future.\u201d<\/p>\n

\n Brilacidin COVID-19 Clinical Trial<\/strong>\n <\/p>\n

The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled, international, multi-center study with planned enrollment of ~120 subjects with moderate-to-severe COVID-19. Two treatment arms are enrolling patients\u2014active and placebo, with ~60 patients per arm. The trial\u2019s primary endpoint is time to sustained recovery through Day 29, using a clinical status ordinal scale based on that used in the series of National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trials (ACTTs). Additional endpoints include: in-hospital outcomes, all-cause mortality, measurement of disease biomarkers and inflammation-related biomarkers, changes to SARS-CoV-2 viral load, and other key measures.<\/p>\n

\n Brilacidin and COVID-19 <\/strong>
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Brilacidin, which has received FDA Fast Track designation for the potential treatment of COVID-19, is one of the few drugs targeting COVID-19 that has been tested in human trials (a total of 8) for other clinical indications, providing established safety and efficacy data on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis. Pre-clinical testing at independent laboratories supports Brilacidin\u2019s antiviral ability to safely and potently inhibit SARS-CoV-2, and multiple strains of human coronaviruses (H-CoVs). In a human lung cell line against SARS-CoV-2, Brilacidin achieved a Selectivity Index of 426. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. Brilacidin antiviral research to date has been limited to laboratory-based experiments. Additional pre-clinical and clinical data support Brilacidin\u2019s inhibition of IL-6, IL-1\u03b2, TNF-\u03b1 and other pro-inflammatory cytokines and chemokines, which have been identified as central drivers in the worsening prognoses of hospitalized COVID-19 patients. Brilacidin\u2019s robust antimicrobial properties might also help to fight secondary bacterial infections, which can co-present in up to 20 percent of COVID-19 patients. Collectively, these data support Brilacidin as a unique 3-in-1 combination\u2014antiviral, immuno\/anti-inflammatory, and antimicrobial\u2014COVID-19 therapeutic candidate, with pan-coronavirus treatment potential. The Company has initiated a randomized, placebo-controlled Phase 2 clinical trial of Brilacidin for treatment of COVID-19 in moderate-to-severe hospitalized patients. A peer-reviewed article in Viruses<\/em> supporting Brilacidin\u2019s COVID-19 treatment potential can be accessed at the link below.<\/p>\n