WAKEFIELD, MA / November 18, 2021 / ACCESSWIRE Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today provided an update on clinical development plans for Brilacidin, the Company’s defensin-mimetic drug candidate being evaluated in clinical testing for multiple indications.
The Company remains optimistic about Brilacidin even though the Brilacidin Phase 2 COVID-19 clinical trial did not meet its primary endpoint. There is much still to learn from the trial, with full analysis of the data ongoing. Should deeper analysis yield promising data, the plan is to submit Brilacidin for inclusion in government-sponsored COVID-19 clinical trial platforms.
The Company is further encouraged by compassionate use of Brilacidin, which involved the treatment of extremely critically-ill patients who had exhausted all other therapeutic options. Compassionate use cases comprised Brilacidin being administered over a longer duration (up to 10 days) than in the Phase 2 COVID-19 trial (3 and 5 day dosing), with some patients also receiving higher and more frequent dosing (two doses every 24 hours). Patient data is planned to be compiled and evaluated, which may shed additional light on Brilacidin’s treatment potential in COVID-19.
More broadly, evaluation of Brilacidin’s broad-spectrum antiviral properties continues through collaborations with NIH scientists and academic researchers, and may introduce opportunities to study Brilacidin in neglected tropical diseases. The Company plans to announce new findings as they are reported to us.
The Company also has not lost sight of the fact that, while Brilacidin for COVID-19 moved to the forefront due to the global pandemic, the focus pre-COVID was on developing Brilacidin for Ulcerative Colitis and Oral Mucositis, both areas of large unmet need with substantial commercial opportunities.
New Inflammatory Bowel Disease (IBD) treatments are sought after given IBD’s complex pathogenesis and variability in patient response to any one drug. Oral delivery of Brilacidin to the gut is focused on developing an immediate release, multi-particulate capsule formulation in preparation for clinical testing of Brilacidin in Ulcerative Colitis. Research on Brilacidin stability in the GI tract and its interaction with the gut’s microbiome also is underway. Oral Mucositis (OM), a painful side-effect of chemoradiation, similarly represents a tremendous unmet need, as there are no approved drugs for prevention of severe OM. The OM competitive landscape has changed significantly, the result of recent later-stage clinical trial failures by Oragenics, Soligenix and Galera. Development of an optimized Brilacidin oral rinse formulation is in progress, with potential to progress to Phase 3 OM testing in 2022.
The Company believes strongly in Brilacidin’s treatment potential and its commercial prospects as a novel drug candidate proven to have antibiotic, anti-inflammatory and antiviral properties. We remain committed to the advancement of our pipeline on multiple fronts and will provide additional updates on pre-clinical and clinical developments as they occur.