Centessa Pharmaceuticals plc (NASDAQ: CNTA) has announced positive interim data from an ongoing phase 1 trial of its highly potent and selective orexin receptor 2 (OX2R) agonist, ORX750, in acutely sleep-deprived healthy volunteers.
The interim data showed that the 2.5 mg dose of ORX750 restored normative wakefulness with a mean sleep latency of 32 minutes as measured by the maintenance of wakefulness test (MWT). This represents a clinically meaningful and statistically significant improvement over the placebo.
In terms of safety and tolerability, the data revealed a favorable profile for ORX750, with no observations of frequently reported on-target adverse events associated with other OX2R agonists. Additionally, there were no cases of hepatotoxicity or visual disturbances across all three dose levels tested (1.0 mg, 2.0 mg, and 2.5 mg).
The company plans to rapidly advance ORX750 into phase 2 studies in patients with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH) beginning in the fourth quarter of 2024.
The phase 1 clinical study is designed to evaluate the safety, tolerability, and pharmacokinetics of single-ascending doses and multiple-ascending doses of ORX750 in healthy adult subjects. The study has completed three single-ascending dose cohorts of healthy volunteers with doses of 1.0 mg, 2.0 mg, and 2.5 mg and has advanced through two cohorts within the cross-over assessment of acutely sleep-deprived healthy volunteers with doses of 1.0 mg and 2.5 mg, administered as a single oral dose. Dosing in the multiple-ascending dose portion of the study is also ongoing.
Today the company's shares have moved 0.1% to a price of $14.95. For the full picture, make sure to review Centessa Pharmaceuticals's 8-K report.
