Antibe Therapeutics Inc(Pre-Merger) ATBPF

Healthcare

Antibe Therapeutics Inc. is a clinical-stage biotechnology company. The Company is leveraging its hydrogen sulfide (H2S) platform to develop therapies to target inflammation arising from a range of medical conditions. The Company’s pipeline includes assets that seek to overcome the gastrointestinal ulcers and bleeding associated with nonsteroidal anti-inflammatory drugs (NSAIDs). Its lead drug, otenaproxesul, is in clinical development as an alternative to opioids and NSAIDs for acute pain. Its second pipeline drug, ATB-352, is being developed for a specialized pain indication. The Company also focuses on inflammatory bowel disease (IBD). Otenaproxesul combines a moiety that releases hydrogen sulfide with naproxen, a non-steroidal, anti-inflammatory drug. ATB-352 is an H2S-releasing derivative of ketoprofen, a potent NSAID commonly prescribed for acute pain. Its IBD candidates are being designed to maintain the efficacy, safety, and pharmacokinetic properties of ATB-429.

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Antibe Therapeutics Inc(Pre-Merger) > Improvement to formulation

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Comment by MrMugsyon Aug 30, 2021 9:27am

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Post# 33780956

RE:Improvement to formulation

The ATE team was under the impression they were getting close to the limits of OTENA, somewhere around 75-100mg. That's why they were playing in that range for the AME. They were trying to pinpoint the pass/fail which would help build thier adaptive P2/3 trial. They were likely wrong as OTENA seems to be more potent than expected.

If the data review shows they can likely go lower, then it makes sense to look at dosing in the 75-50-25-10-5-1mg ranges. Might as well go through them all and find that lower limit.

Certainly doesn't become a red flag for the future if they can get the dosing down. This likely just shows how new H2S is as a field of medicine and how much we still need to learn. As Dan eluded to ... liver marinating in the naproxen - a protective nature w.r.t. the H2S and the liver.

Also, there are higher-dose options (should the lower dosing fail). I think we are a world away from any kind of withdrawl ... but ... let's wait for an update on what they find. That will set the stage, one way or another.

IMO

StockingUp21 wrote:
Will this be needed

https://www.acsh.org/news/2021/08/05/bad-day-antibe-and-pain-patients-15716
Quote::

Unanswered questions

1. This trial was designed to evaluate drug safety, not efficacy. (The company calls it an "absorption, metabolism, and excretion (AME) study.") Given that safety was the endpoint, I'm a little surprised that the doses chosen were 75 mg and 100 mg – rather similar. More commonly, a safety trial would evaluate three different doses that are significantly different from each other, for example, 25, 50, and 100 mg. A larger range of doses would (presumably) make it possible to look for a dose-response relationship, which can help determine whether a given effect is real or artifactual.

2. Three of 35 enrollees who completed the 28-day dosing protocol had a spike in liver enzymes, but this spike was seen in only the high dose group. And this spike, which is anything but subtle, was not seen in earlier trials. This is not easily explained.

3. Despite the significant elevation in liver transaminases in three enrollees, there were no other markers that might suggest liver toxicity.

Best Guess

I don't know how Antibe makes this problem go away, especially since otenaproxesul would (presumably) be used chronically for pain and inflammation. Even if the drug is given at a lower dose, there will always be a red flag attached to it. And it is ironic (unfortunately so) that if otenaproxesul is withdrawn, it would be because of toxicity typical of Tylenol rather than that of traditional NSAIDs.