Mr. Dan Legault reports
ANTIBE REPORTS PK RESULTS OF FIRST CLINICAL STUDY OF OTENAPROXESUL'S NEW FORMULATION
Antibe Therapeutics Inc. has released the PK results of the pharmacokinetic/pharmacodynamic (PK/PD) study of otenaproxesul's faster-absorbing formulation. The study was designed to confirm the drug's safety and inform the selection of treatment regimens for the coming phase II trial, on track to launch in calendar Q1 2024.
The PK/PD study involved 36 healthy volunteers, randomized across three treatment arms: a single high dose and two five-day regimens of otenaproxesul. Subjects remained in-clinic for the duration of their treatment. As previously reported, all subjects completed the study with no clinically significant, drug-related adverse events and no increase in liver enzymes.
In line with preclinical data and DILIsym liver safety modelling, the study confirmed the new formulation's linear, dose-proportional PK, with substantially lower doses needed to achieve target plasma levels compared with the original formulation. More rapid elimination was also observed, expanding the drug's safety envelope. These data provide the basis for selecting treatment regimens to achieve the pain relief expectations of patients, doctors and regulators. They also advance Antibe's exploration of potential treatment regimens for chronic pain.
"Two years of intensive research and reformulation effort are beginning to unlock value for our shareholders," commented Dan Legault, Antibe's chief executive officer. "We appreciate their support as we pursue otenaproxesul's potential as a novel non-opioid and prepare for an exciting year ahead."
About Antibe Therapeutics Inc.
Antibe is a clinical-stage biotechnology company leveraging its proprietary hydrogen sulphide platform to develop next-generation therapies to target inflammation arising from a wide range of medical conditions. The company's current pipeline includes assets that seek to overcome the gastrointestinal ulcers and bleeding associated with non-steroidal anti-inflammatory drugs (NSAIDs). Antibe's lead drug, otenaproxesul, is in clinical development as a safer alternative to opioids and today's NSAIDs for acute pain. Antibe's second pipeline drug, ATB-352, is being developed for a specialized pain indication. The company's next target is inflammatory bowel disease (IBD), a condition long in need of safer, more effective therapies.
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