Antibe Therapeutics Inc(Pre-Merger) ATBPF

Healthcare Biotechnology

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

Antibe Therapeutics Inc(Pre-Merger) > I asked Adan about the China testing of P3...Got a great

<< Previous

Bullboard Posts

Next >>

Comment by Inthepezon Feb 12, 2021 10:30am

184 Views

Post# 32551638

RE:I asked Adan about the China testing of P3...Got a great

Marky1 wrote:

Hey Jean Mark

There is a regulatory body (see definition below) called the NMPA. The ‘Chinese FDA’. The gov’t has done a lot of work recently to up the standards of the NMPA and bring them more in line with global standards (the ICH).

The application for approval of otenaproxesul in China will heavily piggyback on the US FDA file we’ll produce, and we’ll have to do an extra (and smaller) P3 trial in China. (I say ‘we’ because Antibe and Nuance will do together…Antibe has a veto over all decisions…Nuance pays the $$).

Cheers,

D