Alkermes Excels in Narcolepsy Competition with Takeda

Alkermes is in a high-stakes race to deliver phase 2 data for its narcolepsy treatment, ALKS 2680. The company's recent phase 1b findings suggest that ALKS 2680 can compete with Takeda’s TAK-861 despite requiring less frequent administration.

Both Alkermes and Takeda are focusing on treating narcolepsy type 1 (NT1) by addressing the root cause: a deficiency in the neuropeptide orexin. Currently, Alkermes’ ALKS 2680 is behind Takeda’s TAK-861 in the race to market. However, Alkermes' CEO Richard Pops is determined to catch up. During a May earnings call, Pops emphasized the aggressive efforts to advance ALKS 2680, highlighting the company’s commitment to the program.

Alkermes presented their data at the SLEEP 2024 congress, showcasing why ALKS 2680 deserves significant funding. The data came from a phase 1b crossover trial involving 10 patients who received one of three doses of ALKS 2680 or a placebo. Initially, participants took about six minutes to fall asleep in a quiet, dark room, measured by the sleep latency on the Maintenance of Wakefulness Test. The results showed dose-dependent increases in sleep latency, with minutes ranging from 18.4 on 1mg to 34.0 on 8mg. In contrast, the placebo group saw a reduction of 1.4 minutes in sleep latency. Analysts from Mizuho viewed the data positively but noted that it is not yet as mature as Takeda's TAK-861 data.

Takeda disclosed phase 2 results at the same congress, showing improvements in sleep latency of around 30 minutes at the most effective dose. Although ALKS 2680 had better numerical performance, there are significant differences in the trial designs. Alkermes’ sleep latency data were collected during the eight hours following administration, whereas Takeda’s were measured after four and eight weeks. Moreover, Takeda's trial had a significantly larger sample size.

Alkermes is now pushing to deliver its phase 2 data swiftly. The company initiated a midphase study in April and plans to complete enrollment within a year. Meanwhile, Takeda is preparing to advance to phase 3, expecting to start the program within the next four months.

One advantage Takeda holds is the absence of safety concerns that affected Jazz Pharmaceuticals’ rival candidate. Jazz had to delay progress due to reports of visual disturbances and cardiovascular issues, while Takeda’s phase 2 results showed no such red flags. Mizuho analysts find the lack of visual disturbances and liver toxicity in Takeda’s trial "highly encouraging" for ALKS 2680.

Both companies are now on a tight timeline, with Alkermes aiming to catch up to Takeda by delivering promising phase 2 results. The outcome of this race will significantly impact their standings in the narcolepsy treatment market and potentially offer new therapeutic options for patients with NT1.

Alkermes and Takeda are both committed to addressing the neuropeptide orexin deficiency that causes NT1, and the competitive nature of their developments promises advancements in narcolepsy treatment. The forthcoming data from both companies will be pivotal in determining the future landscape of NT1 therapies.