In a news release, Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGW:FSE) presented a summation of its plans for clinical studies during 2021.
Algernon Pharmaceuticals reported that has plans to establish at least one and possibly a second new clinical research program in Q1/20 with the objective of beginning either Phase 1 or Phase 2 clinical trial(s) prior to year-end for new disease indication(s). The firm advised that potential target compounds include drugs that it has already investigated in preclinical animal models or other compounds the company has been reviewing that demonstrate potential for preclinical and perhaps clinical efficacy for a new disease indication.
Algernon stated that "the focus will be on off patent compounds that are already approved in limited markets, but have not been approved in the U.S. or Europe and may include natural occurring compounds that have shown potential as new therapeutic treatments for serious global diseases."
The company noted that it may choose to advance certain compounds for rare orphan diseases. The firm pointed out that the U.S. Food and Drug Administration (FDA) and the European Union respectively provide 7 and 10 years of market exclusivity to medicines addressing some designated orphan disease indications. The company added that it may also wish to pursue new drug applications (NDAs) for products containing chemical entities never previously approved by the FDA either alone or in combination as these would garner a 5-year period of exclusivity.
The firm commented that it is presently working to increase enrollment in its idiopathic pulmonary fibrosis (IPF) and chronic cough clinical research program for NP-120 (ifenprodil). The company stated that the study had experienced delays in patient enrollment rates due to COVID-19, but it is now endeavoring to expand access to the clinical trials for additional patients in Australia and New Zealand. Algernon said that if the final study data is positive, it will then make a determination as to the best path forward whether to be filing a Pre-Investigational New Drug application with the FDA for IPF, chronic cough or both.
The company provided an update on the status of its Phase 2b/3 clinical research study of Ifenprodil for use in treatment of COVID-19. The firm advised that it expects that the final data set from the Phase 2b part of the trial will be available by the end of February 2021. Algernon stated that if the resulting data proves to be positive it intends to consult with the FDA on obtaining Emergency Use Authorization (EUA). The company said that it will be reviewing and interpreting the Phase 2b data in order to best structure the required Phase 3 program even if the FDA does not grant an EUA.
Algernon Pharmaceuticals' CEO Christopher J. Moreau commented, "The Company is in a unique position to leverage its capabilities in identifying compounds for repurposing and managing clinical trials, and to advance additional compounds into clinical studies in a timely and cost-effective manner...Our Chief Science Officer Dr. Mark Williams and I have stated many times that one of our key corporate goals was to have multiple compounds in clinical trials at the same time in order to improve our chances of a success, and that is what we intend to achieve."
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