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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 Pragmatiston Dec 04, 2020 7:39pm
233 Views
Post# 32042698

RE:RE:RE:RE:Updates from Dan

RE:RE:RE:RE:Updates from Dan
MrMugsy wrote:
Pragmatist wrote:
I suspect the CEO was a tad imprecise  in his email.  From the latest MD&A regarding current studies:
 
 
"They are being conducted in tranches to enable a timely start
to Phase III clinical trials. Short range studies are expected to conclude in calendar Q2 2021, enabling the commencement
of the 12-week Phase III efficacy trials. Long range studies are expected to conclude in calendar Q4 2021, enabling the
commencement of 24-week Phase III GI safety trials."


I do recall Dan saying the studies will finish at different times, going out to the end of 2021.  I assumed the only study requred for enabling (FDA meeting and the go-head from them) was the one due in Q4 2020 - toxicity study.  Any chance that's correct?  With the others to follow and to be provided to FDA as they are completed?


I don't recall him mentioning any specific study.  I was under the impression (perhaps wrongly) that the upcoming FDA meeting was more of a consultatory meeting prior to submitting an IND, almost a repeat of the pre-IND meeting but with all Phase 2B results in hand. The company, after all, is moving from trials conducted under Canadian Health authorities to those under the FDA.
 
Having toxicity study results in hand, and any other study results  that might be of interest to the FDA would be a prudent move.

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