Innovation Pharmaceuticals Inc (IPIX)

[Orion Nebula]

I have been poking around and found three very interesting articles. The first is included here with the others to follow in subsequent posts.

The first article indicates to me Leo is trying hard to meet very difficult hurdles in order to be included in a subset of antivirals the FDA will consider for end of the year decision-making and funding. The FDA is prioritizing drugs that can be ready by year end. It appears not many will make it. The approach favors existing approved drugs that are repurposed like Remdesivir. Leo's emphasis on drug manufacturing is paramount as explained in the article. Also noteworthy is the idea that antivirals anywhere in the life cycle of a virus (I know viruses are not alive) are being considered, i.e., prophylactics etc.

Woodcock said the key criteria for inclusion in the program was whether a company could deliver a drug before the end of the year, a difficult hurdle. “This means repurposed drugs or drugs that have undergone rapid clinical development,” Woodcock told reporters.

The first goal was drugs that reduced viral load. That meant antivirals such as remdesivir and passive immunity — a broad term that encompasses both monoclonal antibodies that have been rushed through labs at Regeneron, Eli Lilly, Vir and other companies and convalescent sera, where someone who survives the virus donates their antibody-enriched plasma.

So far, Woodcock said, about 40,000 people have received sera through BARDA and the Mayo Clinic. There are no randomized controlled data yet, but Woodcock said there’s a “strong possibility” it helps. More than 50 different monoclonal antibody programs are now in development, she said, but the administration will focus on those that can reach market before 2021. Eli Lilly has said they could have 100,000 antibodies by the fall, and the BARDA-Regeneron deal covers the delivery of between 70,000 and 300,000 doses around the same time.

Both companies have started their own trials for their drugs, but Woodcock said this summer the NIH will start trials that follow a master protocol to quickly test antibodies and antivirals. She did not indicate which antivirals, but J&J received a $152 million BARDA contract in February to screen for new small molecules. And Merck’s EIDD-2801, now in Phase II trials for Covid-19, has received government funding in the past. According to whistleblower testimony from ousted BARDA chief Rick Bright, it is also a favorite among some officials within HHS.

The goal is to know by the fall which drugs can both treat and prevent Covid-19. But unlike with vaccines, where the FDA has set a 50% benchmark for authorization, Woodcock said there would be no pre-set bar for success. Between prevention, early-stage and late-stage treatment, she said, it would be impossible to set one.

“Unlike a vaccine, we’re talking about maybe a dozen different scenarios. We have small molecules antivirals, we have monoclonal antibodies and prophylaxis and early patient and outpatient and inpatient and so forth,” Woodcock said. “It’s pretty complicated.”

Here is the link to the full article:
https://endpts.com/more-warp-speed-contracts-coming-vaccine-production-to-begin-in-4-6-weeks-officials/

By the way, I find it both amazing and distressing that Ridgeback Therapeutics (now in with Merck) and their drug EIDD 2801 always makes the cut. Not to cause JFM a rise in blood pressure as he has really looked into this with a bit of passion, but it is beyond anything I have ever seen that a drug goes from the petri dish to clinical trials in about 2 or 3 months. Especially a drug that is mutagenic. Something doesn't seem right.