Antibe Therapeutics has received approval from Health Canada to begin the first part of its Phase llb clinical trial of ATB-346.
ATB-346, a hydrogen sulfide-releasing derivative of naproxen, is Antibe’s lead drug designed to reduce chronic pain and inflammation.
The first part of the Phase llb trial is a metabolism protocol that will include 24 healthy subjects over a seven day treatment period.
The protocol’s primary goal is to determine the principle metabolites of ATB-346 in humans, as well as identify their activity and pharmacokinetic profile.
Antibe intends to begin the metabolism trial immediately and plans to complete it by December this year. US-based Veristat will conduct the trial in Toronto, Canada.
The second part of the Phase llb trial is expected to be completed in the second quarter of next year.
Antibe Therapeutics CEO Daniel Legault said: “We are pleased with the approval and excited to begin the first part of this Phase 2B dose-ranging, efficacy study for ATB-346.
“The results will directly inform the dosing cohorts to be used in the subsequent, larger efficacy protocol.
“Moreover, this study will further elucidate ATB-346’s unique metabolic profile and will strengthen our data package as we engage regulatory bodies for Phase lll development and advance strategic partnering activities.”
Antibe is primarily involved in the development of medicines for pain and inflammation by linking a hydrogen sulfide-releasing molecule to an existing drug.
The company’s second drug in pipeline, ATB-352, is designed to bridge the gap of a safer, non-addictive analgesic for treating severe acute pain, while Antibe’s ATB-340 is a GI-safe derivative of aspirin.