Sleep-Disorder Focused Centessa Pharmaceuticals Unveils Interim Data From Lead Program In Acutely Sleep-Deprived Healthy Volunteers

Centessa Pharmaceuticals plc CNTA released interim data from an ongoing Phase 1 trial of ORX750 in acutely sleep-deprived healthy volunteers.

ORX750 showed clinically meaningful and statistically significant improvements in mean sleep latency at the first two doses evaluated (1.0 mg and 2.5 mg) in the Maintenance of Wakefulness Test (MWT) compared to placebo.

MWT is a daytime sleep study that measures the ability to stay awake for a set period. It can help doctors evaluate how well the person responds to excessive sleepiness treatment.

The interim Phase 1 clinical data for ORX750 demonstrated:

• Significantly increased wakefulness in acutely sleep-deprived healthy volunteers compared to placebo at both doses tested.
• Treatment with ORX750 resulted in statistically significant (p<0.05) and clinically meaningful increased sleep latency on the MWT (time to sleep onset over the four sessions performed at ~2, 4, 6, and 8 hours after dosing at 11 p.m., maximum 40 minutes per session) compared to placebo across all doses.
• Mean sleep latencies, as measured by the MWT, for 1.0 mg dose of ORX750 and placebo were 18 minutes and 10 minutes, respectively (p-value = 0.04).
• Mean sleep latencies for the 2.5 mg dose of ORX750 and placebo were 32 minutes and 17 minutes, respectively (p-value = 0.01).
• The 2.5 mg dose was shown to restore normative wakefulness with a mean sleep latency of 32 minutes as measured by the MWT.
• Acutely sleep-deprived healthy volunteers who received a 2.5 mg dose of ORX750 showed a significant 1.6-point improvement versus placebo in mean KSS score compared to baseline (p-value = 0.03).

ORX750 was also shown to have a favorable safety and tolerability profile with no observations of frequently reported on-target adverse events (AEs) associated with other OX2R agonists, and no cases of hepatotoxicity or visual disturbances across all three dose levels tested (1.0 mg, 2.0 mg, and 2.5 mg).

Based on the interim data, the company plans to advance ORX750 into Phase 2 studies in patients with narcolepsy type 1 and type 2, and idiopathic hypersomnia beginning in the fourth quarter of 2024.

Price Action: CNTA stock is up 7.90% at $16.11 at the last check on Tuesday.

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