Antibe Reports Q3 2024 Interim Financial and Operating Results

Antibe Therapeutics Inc. (TSX: ATE, OTCQX: ATBPF), a clinical-stage biotechnology company leveraging its hydrogen sulfide platform to target pain and inflammation, has filed its financial and operating results for the fiscal quarter ended December 31, 2023.

“The results of November’s successful PK/PD study have empowered us to make considerable enhancements to the Phase II trial,” commented Dan Legault, Antibe’s CEO. “These upgrades may enable it to qualify as pivotal, potentially unlocking value by simplifying and shortening otenaproxesul’s remaining path to approval. Even with these enhancements, the trial remains on track to initiate next month – we’re looking forward to an exciting year.”

Business Highlights and Operational Update

The following covers fiscal Q3 2024 and subsequent events:

Progress for otenaproxesul on formulation, IP and commercial potential

• On track to launch upgraded Phase II abdominoplasty trial in March 2024; tablets manufactured and preparation of clinical sites in process
• Phase II trial enhancements include the use of a placebo arm, an increased sample size (300 patient exposures), and the use of adaptive design methodology – these enhancements may enable it to qualify as a pivotal trial for the U.S. FDA
• Completed first-in-human pharmacokinetic/pharmacodynamic (“PK/PD”) study of faster-absorbing formulation:
  • Strong safety results validated DILIsym liver safety modeling results showing acute pain treatment regimens of the new formulation to be liver-safe (DILIsym is a sophisticated software model widely used to predict liver safety in drug development)
  • Confirmed the new formulation’s linear, dose-proportional kinetics, with substantially lower doses needed to achieve target plasma levels compared to the original formulation
  • More rapid elimination also observed, expanding the drug’s safety envelope
  • Taken together, these results provide the basis for upgrading the Phase II trial
• Filed and supplemented patent applications, strengthening IP protection for new formulation to 2043
• DILIsym program underway to explore potential chronic treatment regimens

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