On July 1, 2021, Kowa industries announced that it would do clinical trials for Ivermectin to treat COVID-19. As Pharma Japan reported, “Kowa directly received a request from Nobel laureate Satoshi Omura about conducting such a trial. Dr. Omura won the 2015 Nobel Prize in physiology or medicine for developing Ivermectin.
Kowa is conducting the clinical study in collaboration with Drs. Omura and Hideaki Hanaki, professor at the same university, Hiroshige Mikamo, professor at Aichi Medical University, and the Tokyo Medical Association.
Hiroshige Mikamo has many published papers about antibiotics listed in Research Gate. He belongs to the top 0.23% as an expert in Staphylococcus according to Expertscape.
Hideaki Hanaki, Ph.D., is Managing Director of the Laboratory of Infection Control & Research Center for Infections and Antimicrobials at Kitasato University. He has 237 publications and 6,424 citations.
In October 2021, Pharma Japan issued an update,
According to Kowa, ivermectin’s mechanism of action (MOA) as an antiparasitic agent differs from its MOA against COVID-19. As an antiparasitic, it works by binding to glutamatergic chloride channels in neuromuscular cells of invertebrates. This increases the permeability of cell membranes, leading to the paralysis and death of parasites.
In contrast, ivermectin is expected to work against COVID-19 by inhibiting the binding of coronavirus spike proteins to ACE2 receptors. Coronavirus invades cells by binding its spike proteins to ACE2 receptors on the cell surface, but ivermectin prevents such binding by adhering to the spikes of the virus. In addition, ivermectin is believed to inhibit cytokine production as well.
At that time, Kowa is carrying out a placebo-controlled Phase III trials of ivermectin (Development code of K-237), in Japan enrolling a total of 1,000 adult patients with mild illness who have tested positive for COVID-19 infection by using samples collected within the last 72 hours (500 each in the active-drug group and the placebo group).
In the trial, ivermectin is administered at 0.3-0.4 mg/kg of body weight once daily over three consecutive days. For example, a 60 kg subject would receive a maximum daily dose of 24 mg.
As an antiparasitic agent, ivermectin is administered twice at 0.2 mg/kg at a two-week interval, so the dose of ivermectin used to treat COVID-19 will be higher than the dose used to kill parasites.
In October 2021, Kowa had concluded clinical trial agreements with ten medical institutions and was in talks with around 100 more. “We hope to complete the Phase III trial in November,” Mr. Hayakawa said.
Fast forward to January 31, 2022. Kowa announced that Ivermectin has antiviral properties against the Omicron and the Alpha, Beta, Gamma, and Delta variants. Results are from cultured cells infected with the variants.
Kowa’s press release said,
Kowa confirmed the clinical effect of ivermectin on SARS-CoV-2 and was one of the first to the public. By providing it to everyone, we will contribute to the treatment of new coronavirus infectious diseases as much as possible.
Although the Phase III trial was supposed to finish in November 2021, the timeline was pushed back due to a sudden drop in COVID-19 cases in the country towards the end of last year.
Maybe it’s because Haruo Ozaki, chairman of the Tokyo Metropolitan Medical Association, in a press conference in August 2021, said that doctors could use Ivermectin with the patient’s informed consent.
https://www.youtube.com/watch?v=z51OqoaRd6M
The official press release by Kowa is in Japanese and available at this LINK. I tried to translate with Google, Yandex, and Translatiz but the translations does not make sense so I had to go to Pharma Japan.
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Sources: Pharma Japan July 2, 2021, October 11, 2021, and January 31, 2022
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