Innovation Pharmaceuticals Analyzes Comprehensive Data Set for Its Brilacidin COVID-19 Clinical Trial; Company assesses new pipeline opportunities for 2022
WAKEFIELD, MA / ACCESSWIRE / December 7, 2021 / Innovation Pharmaceuticals (OTCQB: IPIX) (“the Company”), a clinical-stage biopharmaceutical company, today offers shareholders perspectives on the Company’s strategy for the future up to 2022.
The Company is pleased to announce that as of last week it received all unblinded data / data outputs from the recently completed Phase 2 clinical trial of Brilacidin for the treatment of moderate to severe COVID-19 in hospitalized patients. The Innovation team is working with biostatistics partners to explore the data by performing a more in-depth analysis of different subgroups based on patient demographics and baseline characteristics, national COVID-19 standards of care versus l abroad, and more, to potentially identify meaningful patterns and positive trends. Analysis of the compassionate use of brilacidin in the United States in critically ill COVID-19 patients who had exhausted all other treatment options is also planned. Biomarker changes and positive clinical changes were observed, with some compassionate use patients receiving brilacidin more frequently and for a longer period of time than patients in the phase 2 Brilacidin COVID-19 trial. Collectively, these actions will help inform brilacidin’s next steps against COVID-19 over the coming year, as the broad-spectrum antiviral properties of brilacidin continue to be researched through the NIH and other scientific collaborations.
As discussed previously, the Company remains focused on the development of brilacidin as a novel therapy for inflammatory bowel disease (IBD), in particular ulcerative colitis, and also intends to initiate phase 3 testing of the brilacidin as a mouth rinse treatment for oral mucositis (OM) in the head and patients with neck cancer. Drug product development is underway with specialist contract development and manufacturing organizations (CDMOs) tasked with refining the respective formulation of brilacidin. The IBD and OM clinical indications represent broad areas of unmet need, with significant addressable commercial markets.
Elsewhere, the Innovation department is engaged in discussions to potentially 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 needed. There is no warranty, implied or otherwise, that such matters will result in the performance of any definitive agreements.
âWe were surprised when we learned the first results of our phase 2 Brilacidin COVID-19 clinical study. Many factors contributed to our expectations for a successful trial, including a convincing trial. in vitro results against SARS-CoV-2, although we remained pragmatic. Just about every other pharmacy, large and small, has struggled to show clinical benefit in treating COVID-19 hospital patients, âcommented Leo Ehrlich, CEO of Innovation Pharmaceuticals. âAmong critically ill patients who received brilacidin for compassionate use in an open-label manner, we were told that noticeable improvements were seen in key inflammatory biomarkers shortly after receiving treatment with Brilacidin. Subsequent positive changes in the patient’s clinical condition were also observed. We plan to further examine this data, along with performing a subgroup analysis for our Phase 2 COVID-19 trial, as this will help inform our efforts against COVID-19. “
Ehrlich added: âThe company is moving forward with a strategic focus. Efforts are underway to advance the clinical development of Brilacidin on several fronts, as well as to explore potential new additions to the pipeline that could be transformational for our company in 2022. “
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About Pharmaceutical Innovation
Innovation Pharmaceuticals Inc. (IPIX) is a clinical-stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical needs including inflammatory diseases, cancer, infectious diseases and dermatological diseases .
Forward-looking statements: This press release contains forward-looking statements made in accordance with the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding future drug development plans, statements regarding Antiviral capabilities and therapeutic potential of brilacidin and its potential impact. on SARS-CoV-2 (COVID-19) and other viruses. Other statements regarding future product developments, including with respect to specific indications, and all other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause the actual results and experience of the Company to differ materially from the anticipated results and expectations expressed in these forward-looking statements. The Company has, in certain instances, identified forward-looking statements by using words such as âexpectsâ, âbelievesâ, âhopesâ, âbelievesâ, âlookâ, âexpectsâ, âplansâ, â intention “,” objective “,” “potential”, “may”, “suggest” and similar expressions. Other factors that could cause actual results to differ materially from those expressed in forward-looking statements. has the risks of conducting preclinical studies and clinical trials and seeking regulatory and license approvals for Brilacidin and Kevetrin in the United States and other jurisdictions, including without limitation that the compounds of the Company may not successfully complete preclinical or clinical testing, or obtain regulatory approval to be sold and marketed in the United States or elsewhere; results of previous testing may not be reproduced in future studies and trials ; the Company’s need and the availability of substantial capital in the future to fund its operations and research and development, including the amount and timing of the sale of common shares under security purchase contracts; and the Company’s licensee (s) may not pass preclinical or clinical testing and the Company will not receive milestone payments. A more complete description of these and other risk factors is included in the documents filed by the Company with the Securities and Exchange Commission. Many of these risks, uncertainties and assumptions are beyond the Company’s ability to control or predict. You should not place undue reliance on forward-looking statements. Forward-looking statements relate only to information currently available to the Company on the date on which they are made, and the Company does not undertake to publicly disclose the results of any revision of these forward-looking statements that may be made to reflect events or circumstances subsequent to the date of this press release or to reflect the occurrence of unforeseen events, except as required by applicable law or regulation.
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