Algernon Pharmaceuticals Inc. (AGN:CSE; AGNPF:OTCQB; AGW:FSE), a firm that specializes in finding new uses for approved drugs, has received clearances to begin a Phase2b/3 trial for Ifenprodil for Covid-19 by the U.S. Food and Drug Administration (FDA) and Canada Health, and also plans to run the trial in Australia, Romania and the Philippines.
If the data for the Phase 2b trial look positive, the company can seamlessly move into Phase 3 with a larger number of patients.
"For a company like ours, when you start a Phase 2 study under normal circumstances, that's really one of the most important periods of time where you can get the greatest delta in value creation. Not that you don't get value creation with positive Phase 3 data or on marketing approval, but the greatest change can occur during the Phase 2 period," Algernon CEO Christopher J. Moreau told Streetwise Reports.
Ifenprodil, an NMDA receptor antagonist, is approved in Japan and South Korea for treating vertigo and dizziness. Algernon has been investigating its potential treatment for idiopathic pulmonary fibrosis and chronic cough.
"Then we came across an independent research study that Ifenprodil had done very well in an animal study of the world's most lethal flu, avian flu H5N1. In an animal study with a mice, Ifenprodil significantly improved survivability, by 40%, and reduced inflammation in the lungs," Moreau said.
"Our Chief Science Officer looked at the H5N1 data along with the additional fibrosis data we acquired and hypothesized that we might see similar results in humans with Covid-19. We began work three and a half months ago to get a Covid-19 trial going to test our drug. This was really a Herculean task because we're a tiny company, but in that short time, we ended up getting clearance from both Health Canada and the FDA to run a Phase 2b/3 trial for Ifenprodil for Covid-19 and we are supporting an investigator-led Phase 2 study in South Korea," Moreau explained.
The Phase 2b trial will involve three groups of 50 patients: one 50-patient arm will receive existing standard of care plus a daily dose of 60 mg Ifenprodil, a second arm of 50 patients will receive existing standard of care plus a daily dose of 120 mg Ifenprodil, while the third 50-patient arm will receive existing standard of care.
Algernon decided to add the higher-dose arm after more closely working with the U.S. FDA. "Ifenprodil is a very old drug; it was approved in the early 1970s," Moreau explained. "The literature—toxicology data, animal data and also off label studies for other disease indications—showed that higher doses are very well tolerated by humans. We decided that we'd hate to do a trial and wonder if we would have seen a signal with a higher dose. So we rewrote our protocol, but we think will be quite beneficial in the long run to have a high dose and a low dose."
Moreau highlighted an advantage of the drug's known safety profile. "Some 50% of clinical trials at the Phase 2 level fail; of the 50% that fail, 35% fail due to safety. We don't have a safety issue. So 35% of 50% is another 15% that one might muse we could add to our side of the equation. We think we have a 60% to 65% chance of success in our trial."
With no effective therapy for Covid-19, Moreau points out the approval bar has been lowered. "In a typical study, you'll usually get one of three results: your drug really worked well, your drug didn't work at all, or your drug kind of worked. In a normal world, "kind of worked" is almost as bad as it didn't work at all. But in these Covid times, the FDA recently approved a drug called remdesivir, and if you look at the data, it kind of didn't work, it shortened hospital stays from 15 to 11 days, but because it's all they have at the moment, it was approved as an emergency treatment."
The company anticipates it will take a few months to enroll all the patients. The treatment lasts two weeks, and another two weeks are needed for follow up, and then time for data collection, so within three to four months Algernon expects to have data about the drug's efficacy as a treatment for Covid-19.
If the Phase 2 data look good for the 150 patients, Algernon could automatically turn it into a Phase 3 trial, the trial that is needed to be conducted before receiving regulatory approval. "We don't know yet how many patients we will need for the Phase 3; that will be determined by the data from Phase 2. What's nice is we would seamlessly move into a Phase 3 trial, which would be quite a positive situation to be in," Moreau said.
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