Ifenprodil: The Specialized Drug Treating Coronavirus
Algernon Pharmaceuticals Inc (CNSX:AGN) (OTCMKTS:AGNPF) (FRA:AGW) CEO Christopher J. Moreau joined Midas Letter to discuss scaling up manufacturing of NP-120 (Ifenprodil) to prepare for Coronavirus and Acute Lung Injury clinical trials. Ifenprodil has been proven to increase survivability of H5N1 (Asian Avian Influenza or Bird Flu) by 40% and Algernon expects to see similar response in COVID-19 (Corona virus) patients. The company have received positive feedback from the U.S. Food and Drug Administration (FDA) regarding its plans to conduct a phase 2 COVID-19 clinical trial using its repurposed drug NP-120 (Ifenprodil). Algernon Pharmaceuticals is a clinical stage pharmaceutical development company focused on identifying generic drugs with the potential to treat other diseases. If a drug is found to have properties to treat other illnesses, the drug can then be move into clinical trials more efficiently as pre-clinical testing has already been completed. Watch the full interview to learn about the drug Ifenprodil and its applications in treating Corona virus patients.
James West: Christopher J Moreau is my guest now he’s the CEO of Algernon Pharmaceuticals. Chris welcome thank you.
Christopher J Moreau: Thanks for having me.
James West: Chris, what exactly is the business of Algernon Pharmaceuticals?
Christopher J Moreau: Algernon is a drug repurposing company, so our business model is to identify generic drugs that have never been introduced into the US or European market. Investigate them to see if they can treat other diseases. We start out by doing animal studies. If we find that the drug may have potential to treat another disease we file new intellectual property and then we can quickly move the drug into human trials without having to redo all of the preclinical and phase one work. So, it’s a very capital efficient model to identify new drugs to treat diseases.
James West: So, recently you’ve received quite a bit of attention as a result of a drug called Ifenprodil. I’m sure I screwed up that pronunciation.
Christopher J Moreau: Ifenprodil. But you were close!
James West: What is Ifenprodil demonstrating for you?
Christopher J Moreau: Well, we’ve been investigating Ifenprodil for idiopathic pulmonary fibrosis. That is a disease of the lung where fibrosis occurs, and it creates scarring. People have a terrible time breathing and it’s a very tough disease to have. You have about a three-year life once you’re diagnosed and we found that our drug is quite active in the lung. This is a bit technical, but it’s affecting the NMDA receptor and this is a receptor that’s not only present in the brain but also in lung tissue and our Chief Science Officer did the analysis and said I wonder if this drug might also have some impact on lung function and that was the motivation for us to do our animal studies for IPF. We’ve since investigated it for cough, chronic cough. People don’t tend to necessarily think about chronic cough as a big issue but that’s persistent cough over eight weeks. Right now, Merck has a Phase three drug called Gefapixant that they are advancing. Another Canadian company called Bellus has a phase two drug. It’s about a billion-dollar market. There is no drug for cough, it’s being treated by lozenges and cough syrup and so on, but it’s quite a problem. If you’re coughing past post eight weeks and you can’t stop it, it’s a life disrupter, so we were moving our drug along into a phase two trial in Australia when last week my CSO called me quite early in the morning. He said are you up? I said well I’ve answered and I’m known to be a guy at my desk early. He said I think Ifenprodil may be able to treat coronavirus and I said how did you make that connection? He said that he had just come across an independent study that was done in China, where a group was testing H5N1 infected mice. H5N1 is the avian bird flu. There have only been 500 cases recorded and it has a fatality rate of about 53-60%. So, it’s lethal and in mice Ifenprodil improved survivability by 40%. It reduced acute lung injury, which is the result of the infection and it also reduced inflammation in the lung tissue so he said to me if it works this well in an animal model for H5N1, we might see similar response in the corona virus in patients. So we made an announcement last week, by news release, that in fact we had discovered this paper. We let the market know that we were thinking through what’s our best next steps to actually see how we could in fact get this into a human trial quickly. That’s a benefit of a repurposed drug, it’s already safe.
James West: Sure, we already know all of its side effects…
Christopher J Moreau: That’s right. This drug has been developed in the 1970’s by Sanofi and it’s treating neurological conditions in Japan. Vertigo, depression, it’s been investigated for alcohol addiction and there are two very successful repurposing stories and one of them is a drug called Tecfidera. This was a post World War two drug in Germany developed for psoriasis. People that were taking the drug that had MS were telling their physicians that their symptoms were being alleviated enough of the patients reported that they investigated it and now it is a billion-dollar drug for Biogen, Tecfidera. The second example is the Thalidomide, this was a drug developed in the early 1960’s for women who had pre nausea morning sickness and it caused terrible birth defects. But of late, last few years, it’s been investigated as an anti-tumor drug for cancer and it’s a billion-dollar drug for Celgene. So we’re following that same path – finding older safe drugs and seeing if we can find new uses for them and now we can move them quite quickly into human trials
James West: Okay, so if the drug is effective in the upper lungs for remediation of these conditions caused by the coronavirus, COVID-19, is there an expectation that it might have an antiviral element to it as well?
Christopher J Moreau: It would be really fantastic if it did. Right now, we’re considering this as a cytoprotective drug. So, it’s obviously protecting the lung cells. Does it have an antiviral effect? We don’t know yet. It’s something that we’re thinking about just because of the urgency. Having access to a coronavirus assay. They’ve isolated the virus and we could very quickly, by exposing the virus to our drug Ifenprodil, we could find out if it has an antiviral effect and that would be very helpful as well.
James West: Was there any mention of an antiviral effect into the tests of the H5N1 application?
Christopher J Moreau: No and they were specifically just looking at the results. But what’s sort of interesting, and I want to mention this, is how the Chinese came to identify Ifenprodil. The analogy I’d like to use is that our Chief Scientist identified the drug by research. He read papers about the drug – its target mechanism of action, how it worked. The Chinese took lung cells and they did what’s known as a gene knockout. So, they knocked out of the cells about 19,000 genes. They exposed the cells to H5N1. They took the lung cells that survived and they looked at the genes that were effected, what genes were protecting the cells, they then screened 60 drugs to find out what drugs affected the genes that protected the cells and Ifenprodil was number one. Then they ran their animal study for H5N1. So, to give the analogy: my CSO picked out somebody from a crowd from their description, they picked that person out with DNA. That’s the process, so that’s what emboldened us when we saw that data to really start moving forward and as you know, this morning, we announced that we had submitted a package to the FDA to talk about moving forward very quickly into human trials.
James West: Fascinating. So, how soon until we see data that would give us an indication of its antiviral activity if any? Or B) its efficacy for COVID-19 related lung damage?
Christopher J Moreau: the challenge on the viral part is we have to have access to coronavirus and so we would need to be working through laboratories that have isolated it. So, I can’t give you an answer on that. We’re thinking it through. Knowing its antiviral will be helpful, but more
importantly right now is that we’re working on getting it into patients because if its antiviral it will help be more efficacious, but that won’t make the decision should we test them in patients. We think we have enough data. It’s a safe drug. We have strong data for IPF chronic cough H5N1 and, by the way, you can’t test people for H5N1. It’s unethical. Too deadly. So, you can go from an animal trial into an approval. So, we have very powerful data its H5N1 and now that to us and the safety of the drug, we think that should convince regulators and physicians to work with us to try to test it in people.
James West: You bet. Okay, let’s assume best case scenario Ifenprodil is found to be very effective and suddenly everybody in the world who’s effected – currently a hundred and thirty eight thousand cases, everybody would like to get some. How difficult is it to produce? How expensive is it to produce? How much is it going to cost the end users access?
Christopher J Moreau: so our business model was to start synthesis of the drug into our own formulation. So, we have begun that process and we’re formulating for IV, intravenous, because some people who are ill may not be able to take a pill and we’re also formulating for once a day. The current generic supply in Japan is three times a day, so it’s a twenty milligram pill. Our manufacturers are saying that they can have API, that’s the active pharmaceutical ingredient, within three months and depending on what the feedback is from the FDA and how much additional toxicity work they’d like to see, we think we could scale up if needed based on the data in a reasonable time period. We’re talking probably six months, where we can start having what’s known as finished product, the API, and is this either an IV or is it a finished pill, so that people could start to access it, but it would be in comparative speaking to how a drug usually has to go through preclinical phase one and so on, if this would be dramatically faster.
James West: So, theoretically and forward-looking statements and safe harbor language all in front of this question: it’s conceivable that this could be the leading treatment for COVID-19 all things resulting positively from the tests and the FDA processes.
Christopher J Moreau: I’m going to qualify my statement by saying right now we only have animal data that it worked in H5N1. We have our own data and that was an independent study, we have our own data that it worked in IPF and chronic cough. So, we don’t have any human data that we have been able to access that it would work. We’re hopeful it will. What’s interesting about the drug is that it could be an additional therapy. We haven’t seen any contraindications with the drug so it could be added to other drugs, other therapies and that’s what’s interesting about it. This drug seems to be very well tolerated and so it could be one of. I certainly hope it’s therapeutic, it could be protective of the lung as well which would open up different implications, where it could stop somebody from advancing into a more serious lung injury. If we’ve seen its antifibrotic performance, and just to be specific, when we did our IPF animal study we went up against the two leading IPF drugs in the world: Nintedanib and Pirfenidone, Roche and Boehringer, and our drug Ifenprodil outperformed both by 40% and 20%. So, we had a greater reduction in scarring in our animal model and scarring is the result of a viral infection in the lung. So, you could survive a serious case of Corona but now you’ve got some serious lung conditions you’re dealing with the rest of your life. Our drug could be helpful in reducing that scarring so there’s many exciting and we’re quite hopeful and we think it’s because of its safety that we should have an opportunity to work with regulators and physicians to get it tested.
James West: Fascinating, we will be following closely, thanks very much for joining me today.
Christopher J Moreau: Thank you for having me.
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