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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, 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 Thejew on Jun 02, 2020 10:00am
265 Views
Post# 31100923

RE:RE:Phase 2b Review - Medical Only

RE:RE:Phase 2b Review - Medical OnlyFrom IR:

To your question about WOMAC scores … in this trial, we used a WOMAC multi-part 500-point scale rather than a 20-point, simpler scale (the FDA prefers a 500 point scale for larger trials such as this one) … these WOMAC numbers are extremely hard to interpret if you’re not a stats or pain expert… as noted above, it’s all about the statistical significance (p-values). The p-values are the key result and the central numerical facts in discussions with commercial partners and regulators, and they demonstrate strong efficacy, comparable to efficacy shown by other NSAIDs at the 4-6 week mark, which tends to be the point where max efficacy is reached with NSAIDs (note that our data is at the 14-day mark). These results are similar to and consistent with the earlier (albeit much smaller) Phase 2A trial. To your question regarding follow up, the statisticians at Veristat are in the process of summarizing the WOMAC data that underlies the p-values we reported, and we expect to provide a summary of that data on our website later this month – we will alert you when it’s available.
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