Algernon Pharmaceuticals Inc (CSE:AGN) (OTCQB:AGNPF), the drug repurposing company, outlined its key plans for the year ahead, noting that if data is positive from its Ifenprodil coronavirus (COVID-19) trial, it will look to get emergency use authorization (EUA) from the US FDA.
The final set of data from the Phase 2b part of its Phase 2b/3 clinical trial assessing the drug to treat the coronavirus will be available at the end of February, the company said in a statement.
READ: Algernon rapidly advances Ifenprodil as a potential COVID-19 treatment and for battling respiratory diseases
Algernon also told investors it would mull conducting a Phase 3 trial, which will be required regardless of whether or not it receives an EUA.
"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,” CEO Christopher Moreau told investors in a statement.
Also on the cards for next year are plans to increase the enrollment rate of the firm's trial of Ifenprodil on Idiopathic Pulmonary Fibrosis (IPF) and chronic cough, which was slowed due to the pandemic, the company noted.
Once that trial is closed and the final data has been reviewed and is positive, Algernon will evaluate next steps, which may include filing a pre-IND application with the US FDA for IPF or chronic cough or for both, it added.
Algernon also said it planned to establish a minimum of one and possibly two new clinical research programs in the first calendar quarter, with plans to start a Phase 1 or a Phase 2 clinical trial before the end of the year, for a new disease indication or indications.
The focus will be on off-patent compounds that are already approved in limited markets, but have not been approved in the US or Europe.
The drugs group added that it may also advance potential 'Orphan' drug status compounds and may also rely on the five-year period of exclusivity granted to new drug applications for products containing chemical entities never previously approved by the US FDA either alone or in combination.
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