According to a statement from US President Donald Trump, the US Food and Drug Administration (FDA) will fast-track treatments for novel coronavirus (COVID-19). Though there are still months of research ahead, there are several new developments from drug developers and producers that are giving the market hope, including Gilead Sciences, Inc. (NASDAQ:GILD), Mylan N.V (NASDAQ:MYL), Eli Lilly and Company (NYSE:LLY), Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Algernon Pharmaceuticals Inc. (CSE:AGN).
RE-PURPOSING DRUGS FOR OTHER DISEASES
Among the potential covid-19 candidates, heightened mainstream attention has been given to two drugs: hydroxychloroquine (oral), and remdesivir (intravenous).
Though both are already approved and on the market, there are others in the works. One such potential option is the re-purposed drug NP-120 (Ifenprodil) from Algernon Pharmaceuticals Inc. (CSE:AGN) (OTC:AGNPF). The company recently announced it will support an investigator initiated Phase 2 clinical trial of the drug for COVID-19 with leading Asia-Pacific clinical research organization (CRO), Novotech.
The company recently released an overview of its Ifenprodil program pertaining to COVID-19. Algernon has built itself as a company that repurposes drugs, by investigating safe, already approved drugs for new disease applications, and moves them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets.
Specifically, Algernon has targeted compounds that have never been approved in the US or Europe to avoid label prescription writing.
In the case of Ifenprodil, it’s already approved in South Korea and Japan for certain neurological conditions with a known safety history. After receiving input from investigators, Algernon is now in the process of refining the protocol for the phase 2 coronavirus study. The study approval process may be expedited, much like what the FDA is doing, due to the current global health crisis.
Since taking it on, Algernon has shown some promising results for the drug.
For idiopathic pulmonary fibrosis (IPF or lung scarring), Ifenprodil outperformed the world’s two leading IPF treaments, Nintendanib and Pirfenidone, in a pre-clinical in vivo animal study, reducing fibrosis by 56% with statistical significance.
It also outperformed Merck’s Phase III drug Gefapixant in a recent acute cough animal study by 110%. An independent study found that it also significantly reduced acute lung injury and improved survivability in an animal study with Avian H5N1 infected mice by 40%. This data helped convince the company that Ifenprodil may be effective as a possible therapeutic treatment for COVID-19.
Lastly, Ifenprodil was also shown in a separate independently published in vivo study to prolong survival under low oxygen (anoxic) conditions, as might occur in patients with severely impaired lung function.
So, with pre-approved drugs in other parts of the world and for other diseases, there is hope.
With the case of hydroxychloroquine or chloroquine, the early data is promising. It’s an older established drug, used to treat malaria.
In the response to the heightened demand for patients to try it the fight against COVID-19, one of the makers of the drug, Mylan N.V (NASDAQ:MYL), has announced it will ramp up US manufacturing of the tablets.
But perhaps the drug that’s gotten the most attention from the US government so far, is remdesivir from Gilead Sciences, Inc. (NASDAQ:GILD). President Trump even touted the drug during a press conference, as under the US government’s “compassionate use” program, the administration is hoping to expand so even more people can access the experimental therapy.
Unlike hydroxychloroquine and ifenprodil, which are approved and marketed for other uses in other markets, remsdesivir had its research halted after initial development after it wasn’t proven to be as effective as intended for treating Ebola as other treatments. And as of yesterday, the drug’s access was suspended yet again, this time for COVID-19, so its efficacy on the issue is in limbo.
NEW TREATMENTS FOR THE NOVEL VIRUS
In the case of Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN), the multi-billion-dollar developer crafts human antibodies out of genetically engineered mice. This time, the company is attempting to use that technology in hopes of treating coronavirus, with an antibody cocktail that the CEO believes could be available “quickly”. Regeneron believes its existing arthritis drug, Kevzara, might prove useful in treating lung inflammation in COVID-19 patients.
Eli Lilly and Company (NYSE:LLY) is currently partnered with Canadian firm AbCellera to develop antibody treatments for coronavirus infection. Armed with a blood sample from a coronavirus survivor, AbCellera has identified 500+ antibodies that could potentially protect against the virus. Through the partnership with Eli Lilly, the duo will work to identify which are the most potent, with the aim of having a treatment for human trials within the next four months.
Algernon Pharmaceuticals Inc. (CSE:AGN) has been quite active with the development of its repurposed drug NP-120 (Ifenprodil) for the treatment of acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) associated with COVID-19 infection.
“Since NP-120 Ifenprodil has a known safety history, it can move into a clinical trial on an immediate basis”, said Christopher J. Moreau CEO of Algernon. “This is one of the benefits of investigating an older drug that has a known safety history, for new diseases.”
In the US, Algernon has requested direction from the FDA regarding the use of Algernon’s planned new proprietary injectable and slow release formulation as well as the use of the company’s currently available Ifenprodil drug supply, for a US clinical trial on an emergency use basis.
This filing also includes clarification of the expanded access pathway, also known as the “compassionate use” pathway.
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