WAKEFIELD, MA / December 7, 2021 / ACCESSWIRE Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, today provides shareholders with perspectives on the Company’s go-forward strategy heading into 2022.
The Company is pleased to report that as of last week it had received all unblinded data/data outputs from the recently completed Phase 2 clinical trial of Brilacidin for treatment of moderate-to-severe COVID-19 in hospitalized patients. The Innovation team is working with biostatistics partners to explore the data—conducting deeper analysis of different subgroups by patient demographics and baseline characteristics, domestic versus overseas COVID-19 standards of care, and more—to potentially identify meaningful patterns and positive trends. Analysis of the compassionate use of Brilacidin in the U.S. in critically-ill COVID-19 patients who had exhausted all other therapeutic options also is planned. Changes to biomarkers and positive clinical changes were observed, with some compassionate use patients administered Brilacidin more frequently and over a longer duration than patients in the Phase 2 Brilacidin COVID-19 trial. Collectively, these actions will help inform next steps for Brilacidin against COVID-19 in the coming year, while Brilacidin’s broad-spectrum antiviral properties continue to be researched through NIH and other scientific collaborations.
As discussed previously, the Company remains focused on developing Brilacidin as a novel therapy for Inflammatory Bowel Disease (IBD), specifically Ulcerative Colitis, and also has plans to initiate Phase 3 testing of Brilacidin as an oral rinse treatment for Oral Mucositis (OM) in head and neck cancer patients. Drug product development is ongoing with specialized Contract Development and Manufacturing Organizations (CDMOs) responsible for refining the respective Brilacidin formulation. The IBD and OM clinical indications represent large areas of unmet need, with significant addressable commercial markets.
Elsewhere, Innovation management is engaged in discussions potentially to acquire rights to new pipeline assets, as well as to enter into new licensing agreements. The Company plans to provide updates on these matters as warranted. There is no guarantee, implied or otherwise, that such matters will result in the execution of definitive agreements.
“We were surprised when we learned the topline results of our Phase 2 Brilacidin COVID-19 clinical study. Many factors contributed to our expectations for a successful trial, including compelling in vitro results against SARS-CoV-2, even while we remained pragmatic. Just about all other Pharmas, both large and small, have struggled to show clinical benefit in treating hospitalized COVID-19 patients,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “Among critically-ill patients who received Brilacidin under compassionate use in an open label manner, we were told noticeable improvements were seen in key inflammatory biomarkers shortly after receiving Brilacidin treatment. Subsequent positive changes to patient clinical status were also observed. We plan to review these data further, alongside performing subgroup analysis for our Phase 2 COVID-19 trial, as it will help inform our efforts against COVID-19.”
Ehrlich added, “The Company is moving ahead with a strategic focus. Efforts are underway to advance Brilacidin’s clinical development on multiple fronts, as well as to explore potential new pipeline additions that could be transformational for our company in 2022.”