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Bullboard - Stock Discussion Forum Antibe Therapeutics Inc(Pre-Merger) ATBPF

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,... see more

GREY:ATBPF - Post Discussion

Antibe Therapeutics Inc(Pre-Merger) > Improvement to formulation
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Post by StockingUp21 on Aug 29, 2021 7:25pm

Improvement to formulation

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 And it is ironic (unfortunately so) that if otenaproxesul is withdrawn, it would be because of toxicity typical of Tylenol rather than that of traditional NSAIDs.

Comment by Danorrn on Aug 30, 2021 7:49am
I like this actually..."And it is ironic (unfortunately so) that if otenaproxesul is withdrawn, it would be because of toxicity typical of Tylenol rather than that of traditional NSAIDs." Toxicity typical of tylenol. Why would they withdraw if it is typical of a drug already in use? Surely you know how much tylenol is used internationally and how much cash that represents?
Comment by MrMugsy on Aug 30, 2021 9:27am
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 ...more  
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