Alkermes has shown more of the data that persuaded it to throw money at its narcolepsy program. The phase 1b readout suggests Alkermes’ ALKS 2680 can hold its own against Takeda’s rival prospect despite being administered less frequently.
Both drug developers have latched on to the potential to treat narcolepsy type 1 (NT1) by addressing the neuropeptide orexin deficiency at the root of the condition. Alkermes’ ALKS 2680 is trailing Takeda’s rival asset TAK-861 in the race to market. But CEO Richard Pops is pulling out all the stops to catch up, telling investors on a May earnings call that Alkermes is “leaning into that one as aggressively as we can.”
Alkermes is using the SLEEP 2024 congress to show why, in Pops words, ALKS 2680 “gets what it needs” in terms of funding. The company arrived at the event armed with data on 10 patients who received one of three doses of ALKS 2680 or placebo in a phase 1b crossover trial.
At baseline, participants took around six minutes to fall asleep in a quiet, dark room, a measure known as sleep latency on the Maintenance of Wakefulness Test. Alkermes saw dose-dependent increases in sleep latency ranging from 18.4 minutes on 1mg to 34.0 minutes on 8mg. Sleep latency fell 1.4 minutes on placebo. Mizuho analysts took a positive view of the data, with a caveat.
“Phase 1b ALKS 2680 data from the full NT1 cohort demonstrate ALKS-2680's impressive efficacy and look competitive with Takeda's phase 2 TAK-861 data in NT1. However, we caution that the comparison is not apples-to-apples as Alkermes' data are not as mature as Takeda's TAK-861,” the analysts wrote in a note to investors.
Takeda shared phase 2 results at SLEEP 2024, linking (PDF) its prospect to improvements in sleep latency of around 30 minutes at the most effective dose. While ALKS-2680 performed better numerically, Alkermes’ MWT data were from the eight hours after administration and Takeda measured sleep latency after four and eight weeks. Takeda enrolled more than ten times as many participants.
Alkermes is now racing to deliver its own phase 2 data. The company started a midphase study in April and is aiming to take around one year to complete enrollment. The next step for Takeda is to start a phase 3 program, something it expects to happen in the next four months.
Takeda is pushing into phase 3 after avoiding the safety problems that rocked Jazz Pharmaceuticals’ rival candidate. Jazz pumped the brakes because of reports of “visual disturbances” and cardiovascular effects but Takeda’s phase 2 results were free from red flags. Mizuho analysts said the absence of visual disturbances and liver toxicity in Takeda’s trial is “highly encouraging for ALKS-2680.”