Centessa’s New Drug Shows Promising Results In Tackling Sleep Deprivation

Nxera Pharma Co., Ltd., previously known as Sosei Group or Sosei Heptares, has acknowledged Centessa Pharmaceuticals' announcement made on 10 September 2024. The announcement revealed promising interim results from a Phase 1 clinical trial of ORX750, conducted on acutely sleep-deprived healthy participants.

ORX750, an investigational oral drug, is a highly potent and selective orexin receptor 2 (OX2R) agonist. Developed using Nxera's proprietary technology, it specifically targets the loss of orexin neurons, a key factor in narcolepsy type 1 (NT1). The drug shows potential for treating other conditions like narcolepsy type 2 (NT2), idiopathic hypersomnia, and additional sleep-wake disorders where orexin levels remain normal.

Centessa announced that ORX750 demonstrated both clinically significant and statistically notable improvements in average sleep latency at the initial two doses tested (1.0 mg and 2.5 mg) during the Maintenance of Wakefulness Test (MWT), outperforming the placebo. Notably, the 2.5 mg dose successfully restored normal wakefulness, achieving an average sleep latency of 32 minutes, as measured by the MWT.

Additionally, ORX750 exhibited a strong safety and tolerability profile, with no frequent on-target adverse events commonly seen with other OX2R agonists. There were no reports of hepatotoxicity or visual impairments across all three dosage levels (1.0 mg, 2.0 mg, and 2.5 mg) up until the data cutoff.

Centessa, drawing from the interim results, intends to move ORX750 swiftly into Phase 2 trials, focusing on patients with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH). These trials are scheduled to commence in the fourth quarter of 2024. Nxera will provide updates if any milestone events trigger a significant payment from Centessa to Nxera.