Early results from a small study have convinced Centessa Pharmaceuticals to “rapidly advance” an experimental drug it believes could be a useful treatment for diseases hallmarked by excessive sleepiness.
The study enrolled healthy volunteers who hadn’t gotten enough sleep for a short period of time. It then assessed three doses of Centessa’s drug, one of which was only evaluated for safety. According to Centessa, the two tested doses significantly increased the amount of time it took for participants to go from fully awake to asleep, compared to placebo.
The London-based biotechnology company now intends to start, before the end of the year, mid-stage studies that will evaluate its drug against the two main types of narcolepsy as well as an uncommon sleep disorder known as idiopathic hypersomnia.
The smaller study “set a high bar” for the drug, and the data generated thus far has “exceeded our expectations, giving us the confidence to accelerate the program into the next stage of clinical development earlier than anticipated,” said Saurabh Saha, Centessa’s CEO, in a statement.
Centessa’s share price was up 8% at market’s open Tuesday. It rose higher, to a gain of more than 15%, before sliding back down in late morning trading.
David Risinger, an analyst at the investment firm Leerink Partners, called the data “highly compelling” and the best so far from a new class of drugs aimed at sleepiness. The class targets “orexin” proteins, which regulate sleep and wakefulness, and has gotten buy-in from a growing list of developers that includes Takeda Pharmaceutical, Johnson & Johnson, Jazz Pharmaceutical and Alkermes.
Early this year, Takeda said it would quickly begin late-stage testing of its orexin drug after scoring positive results from a clinical trial focused on “Type 1” narcolepsy — a condition that, in addition to sleep problems, also involves a sudden loss of muscle control.
To Risinger, the data released Tuesday suggest that Centessa’s drug could ultimately be given as a 1 milligram, once-daily treatment, which would “compare favorably” to Takeda’s candidate. That drug has been evaluated at once- and twice-daily doses, up to 7 milligrams a day. Centessa’s results also imply that its drug is absorbed by the body faster than Takeda’s, according to Risinger.
Centessa derived its data from “Maintenance of Wakefulness Tests,” a long-running tool used in sleep studies. The tests have participants sit in a dark, quiet room, on a bed with their back and neck supported by pillows. Sensors are attached to the head and face of the participant, who is then asked to look straight ahead and try not to fall asleep. One round of the test lasts no longer than 40 minutes, and is repeated approximately every two hours for several sessions.
In Centessa’s study, dosing occurred at 11 p.m. and four total sessions were conducted. In the lowest, 1 mg arm, the average time it took to fall asleep was 18 minutes for drug-treated participants and 10 minutes for those on placebo. In the highest, 2.5 mg arm, the times were 32 minutes and 17 minutes, respectively — which, Centessa said, shows that the dose restored “normative wakefulness.”
The company also classified the safety and tolerability of its drug as “favorable.” All adverse events related to treatment were “mild and transient,” and none led to any participant dropping out of the study. Researchers also haven’t observed adverse events associated with other orexin drugs that work like Centessa’s, such as frequent urination or needing to urinate, insomnia, blood pressure increases or increased saliva production.
