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) > Corp Update

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Comment by RunningofdBullson Jul 27, 2021 9:29am

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Post# 33609379

RE:Corp Update

you forgot the best part though..."we are now interacting with pharmaceutical companies around the globe, with several conversations having reached the confidential stage"

WalkOverTheStrt wrote: Key takeaways

On Track- "associated CMC (chemistry, manufacturing and controls) activities are on schedule"

On track - IND-opening single-dose detailed pharmacokinetics/ pharmacodynamics study dosed.

On track - AME study "Following the anticipated completion of this study in the upcoming quarter, we will request a meeting with the FDA; that meeting will be the last key milestone before Phase III initiation."

Good - Building the bench and expertise - "retained a former chair of the U.S. FDA’s Advisory Committee on Anesthesia, Critical Care and Addiction Products for ongoing advice / process of selecting three physicians to constitute the Independent Data Monitoring Committee (“IDMC”) / hiring of Dr. Ana Stegic as our Director of Clinical Operations

Unclear - "more than two years of runway and fully funds the "initial" Phase III trial" what is meant by intial?

Never Too Late But Surprised this wasn't finalized months ago / potential covid delay to tour facilities or? "currently evaluating proposals from leading global contract research organizations (“CROs”) "

Not Great - IMO this is a delay as I would have expected enrollement Q4 from all their previous statements - "efficacy trial is planned for approximately 50 sites in the U.S. and Canada, with enrollment set to commence in Q1 2022"