- Algernon Pharmaceuticals (CSE:AGN) has filed its pre-Investigational New Drug meeting request with the US FDA
- The pre-IND will initiate formal communications with the FDA regarding the development of NP-120 (Ifenprodil)
- NP-120 may potentially be able to treat a range of lung and respiratory conditions associated with COVID-19
- Algernon Pharmaceuticals (AGN) is currently down 8.33 per cent to C$0.22 per share
Algernon Pharmaceuticals (CSE:AGN) has filed its pre-Investigational New Drug meeting request with the US FDA.
Receipt of the pre-IND will open a formal line of communication with the regulatory authority regarding Algernon’s NP-120 (Ifenprodil) drug.
Sanofi originally developed NP-120 in the 1970’s, for the treatment of circulatory disorders. Algernon has now repurposed it as a potential remedy for acute lung and respiratory distress associated with COVID-19.
Christopher J. Moreau, CEO of Algernon Pharmaceuticals, acknowledged the significant progress.
“This is a very important step for the company as we move forward on our strong belief, based on data, that NP-120 may be an effective treatment for coronavirus.
“I would like to thank the entire Algernon team for all the hard work and dedication this past week that went into preparing our pre-IND application,” he said.
The company decided to file with the FDA after a recent independent study discovered that NP-120 significantly reduced acute lung injury (ALI).
It also found that it reduced the mortality of Asian H5N1 in mice by 40 per cent. Asian H5N1 is the most severe known form of influenza, with a mortality rate of 50 per cent.
In a separate study, NP-120 also prolonged survival in low oxygen conditions, which is common in patients with severely impaired lung function.
Algernon’s filing to the FDA outlined a proprietary slow-release injectable, as well as an associated clinical trial for emergency use.
“We will update the market shortly on the direction we receive from the US FDA. Based on circumstances, we are hoping for an expedited response,” added Moreau.
Algernon Pharmaceuticals (AGN) is currently down 8.33 per cent to C$0.22 per share at 2:51pm EST.