- Study delivers data required for Phase II trial, on track to initiate next quarter
- Confirms linear, dose-proportional pharmacokinetics
- Complements strong safety data already reported
Antibe Therapeutics Inc. (TSX: ATE, OTCQX: ATBPF), a clinical-stage biotechnology company leveraging its hydrogen sulfide platform to develop next-generation therapies targeting pain and inflammation, is pleased to announce 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 upcoming 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 modeling, the study confirmed the new formulation’s linear, dose-proportional PK, with substantially lower doses needed to achieve target plasma levels compared to 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 CEO. “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 sulfide 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 nonsteroidal 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. Learn more at antibethera.com.
Forward Looking Information
This news release includes certain forward-looking statements under applicable securities laws, which may include, but are not limited to, the anticipated scope, timing, duration and completion of certain of the Company’s pre-clinical and clinical trial programs and studies including the Phase II trial and the anticipated timing for seeking market approval for certain of the Company’s drugs and therapies for certain additional indications. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “will”, “anticipate”, “believe”, “plan”, “estimate”, “expect”, “intend”, “propose” and similar wording. Forward-looking statements involve known and unknown risks and uncertainties that could cause actual results, performance, or achievements to differ materially from those expressed or implied in this news release. Factors that could cause actual results to differ materially from those anticipated in this news release include, but are not limited to, the Company’s inability to timely execute on its business strategy and timely and successfully complete its clinical trials and studies, the Company’s inability to obtain the necessary regulatory approvals related to its activities, risks associated with drug development generally and those risk factors set forth in the Company’s public filings made in Canada and available on sedar.com. The Company assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those reflected in the forward-looking statements except as required by applicable law.
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