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Antibe Therapeutics Inc(Pre-Merger) T.ATE


Primary Symbol: 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, 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.


GREY:ATBPF - Post by User

Comment by drippingsnoton Sep 09, 2020 6:07pm
141 Views
Post# 31530811

RE:RE:RE:RE:RE:Dr. John Wallace

RE:RE:RE:RE:RE:Dr. John WallaceThat's a good point Marky but I don't think it would have solved anything.
If you left out 150 mg, FDA would likely ask ... How low can you go before it fails?
We would probably be in the same position, doing a Phase2/3.

Back to my original question from a few weeks ago ...
In Phase 2/3, we obviously get to look at the PART 1 data to determine the dose.
It's like a window into our Phase 3 trial.
Who wouldn't want to design a trial in a two-step fashion so you can have an early peak to see how things are going?  I think Stauffer said (at BioPUB) he would always design it this way going forward.  I can see why.

That's just how I'm seeing this design as a small PART 1 (Dose Determination and an unsuspecting window into the continuation) and then a large PART 2 (Continuation).
Can anyone clarify if I've got it right or wrong?
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