A safety issue with its lead drug has chopped a big hole in the share price for Canadian pharma company Antibe Therapeutics (Antibe Therapeutics Stock Quote, Charts, News, Analysts, Financials TSX:ATE). But portfolio manager Robert McWhirter says there’s still enough potential in the company to warrant your attention.
“The big debate becomes where to from here?” says McWhirter, president of Selective Asset Management, who spoke about Antibe on BNN Bloomberg on Friday.
“Part of the trial was suspended because in one of the arms three patients had above normal liver enzymes, so that part of the trial was halted,” McWhirter said.
Toronto-based Antibe is aiming to take a bite out of the huge pain and inflammation market by developing a next-generation non-steroidal anti-inflammatory drug (NSAID) in otenaproxesul, a proprietary hydrogen sulfide-releasing analog of naproxen. So far in clinical trials for osteoarthritis, the otenaproxesul platform has shown strong efficacy while generating limited gastrointestinal side effects, an issue which plagues current NSAIDs.
But last month, Antibe announced a halt to one study being conducted in preparation for its planned Phase III trial for otenaproxesul. In a press release on August 3, Antibe said a pre-specified safety threshold was exceeded in its absorption, metabolism and excretion (AME) study, which involved 42 patients on either 75 mg or 100 mg daily doses. The company said three subjects in the 100 mg cohort, after having completed the full 28-day drug administration period, showed higher liver transaminase levels of over five time the upper limit of normal. Antibe said other indicators of liver function for the three subjects were found to be normal, and the company plans to provide an update on its data analysis of the AME study in October.
“Although the treatment duration was longer than in previous Antibe studies, these observations were unexpected given the results of efficacy, safety and pharmacokinetic studies conducted to date,” Antibe said in a press release.
“The Company will continue to collect and analyze additional data over the next several weeks to understand the cause and implications of these events and to determine the optimal plan for the continued development of otenaproxesul. In parallel, Antibe will discuss the status of the AME study and the development path going forward with Health Canada. The Company will update its shareholders once this work is complete,” Antibe said.
The news did a number on Antibe’s stock which on August 3 went from $3.39 to $1.00, with little movement in ATE over the ensuing month.
But McWhirter said Antibe is far from down and out, as its platform could have a lucrative application in the post-operative, acute care market.
“There were a variety of dosages [in the otenaproxesul study] – 100 milligrams 75 milligrams, etc. – and the market is expecting to get the results of the 75 kilogram arm fairly soon. We’ll find out whether or not that has less liver toxicity,” McWhirter said.
“All that being said, Antibe has enough cash to keep them going for the next two and a half years. In addition, they’ve found a new metabolite in conventional naproxen which has also been part of this study as well as their own drug. Hydrogen sulfide, which is part of what they do, reduces inflammation and a whole bunch of different diseases, and there’s a potential other application even if it turns out that the product doesn’t work for creaky knees,” he said.
“There are over 50 million surgeries in the US per year, and for post operative pain currently 80 per cent of patients are prescribed with opioids. That’s a concern because of potential addiction and abuse. So, the advantage of Antibe’s product is even if it does affect the liver, you’re normally on acute treatment post surgery for only two weeks. So the expectation is, okay, you can take this as an alternative because it’s an extremely high potency drug as an alternative to opioids and not have to worry about it because you’re only going to be taking it for two weeks. That market itself is quite significant,” McWhirter said.
McWhirter said between now and the end of the calendar year, investors will get more information from Antibe on the otenaproxesul trials.
“Overall, we’re still waiting to see. [It’s] an interesting opportunity, particularly in the acute market potential,” he said.
Antibe delivered its first quarter fiscal 2022 financials in mid-August, showing a cash position of $66.8 million compared to $72 million at the end of the previous quarter. Revenue for the fiscal Q1 was $2.7 million, coming from its regenerative medicine subsidiary Citagenix. The net loss for the quarter was $6.3 million or $0.13 per share. Over the quarter, Antibe cleared an Investigational New Drug filing with the US FDA to allow human clinical trials in the US for otenaproxesul.
Year-to-date, ATE is currently down 69 per cent.