Drugs

Centessa Promising Data for Sleep Disorder Drug

Centessa Pharmaceuticals is reporting encouraging clinical data for its oral OX2R agonist ORX750 in patients with narcolepsy Types 1 and 2 (NT1, NT2) and idiopathic hypersomnia (IH). In a third-quarter financial update, the biotech firm says data from the initial dosing cohorts of its ongoing Phase 2a CRYSTAL-1 study showed statistically significant, clinically meaningful, and dose-dependent improvements in key sleep and wakefulness measures — including the Maintenance of Wakefulness Test (MWT), Epworth Sleepiness Scale (ESS), and Weekly Cataplexy Rate (WCR).

“These data signal a potentially wide therapeutic window for ORX750 and provide strong mechanistic rationale to enhance efficacy and dosing flexibility within ongoing dose-escalation cohorts,” a company release says. “Based on the strength of these results, we expect to initiate the registrational program for ORX750 in the first quarter of 2026.”

The company says the study in NT1 patients showed significant improvements compared with placebo. For example, mean sleep latency on the MWT increased by more than 20 minutes in the 1.5 mg group, and ESS total scores improved to a mean of 5.1 with treatment vs. 18.7 with placebo. In NT2 patients, participants in the 4.0 mg cohort saw a greater than 10-minute improvement in MWT sleep latency and a drop in ESS score to 8.1 from a baseline of 17.3. And in IH patients, the 2.0 mg ORX750 cohort improved MWT scores with a p-value of 0.0213, which the company says marks the first demonstration of statistically significant and clinically meaningful benefit for an OX2R agonist in these patients.

Centessa says ORX750 was generally well tolerated during the study, with most treatment-emergent adverse events mild to moderate. The most common side effects were increased urination (51%), insomnia (22%), dizziness (13%), and headache (11%).

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome