Alkermes narcolepsy drug shows positive results in phase 2 trial

DUBLIN - Alkermes plc (NASDAQ:ALKS), a pharmaceutical company with a market capitalization of $4.8 billion and an impressive 84% gross profit margin, announced Monday that its experimental narcolepsy treatment alixorexton demonstrated statistically significant improvements in wakefulness compared to placebo in patients with narcolepsy type 1.According to InvestingPro data, Alkermes maintains strong financial health with more cash than debt on its balance sheet, positioning it well for continued drug development. InvestingPro offers 8 additional key insights about Alkermes’s financial position.

The drug, an oral orexin 2 receptor agonist, met the primary endpoint in the phase 2 Vibrance-1 study across all three doses tested (4mg, 6mg, and 8mg), showing dose-dependent improvements in the Maintenance of Wakefulness Test after six weeks of once-daily treatment.

Alixorexton also showed statistically significant improvements in excessive daytime sleepiness as measured by the Epworth Sleepiness Scale. The 6mg dose significantly reduced weekly cataplexy rates compared to placebo.

The company reported that the drug demonstrated clinically meaningful improvements in patient-reported outcomes related to disease severity, fatigue, and cognitive function at all doses tested.

"These compelling results demonstrated that once-daily alixorexton normalized wakefulness and excessive daytime sleepiness scores in highly symptomatic patients with narcolepsy type 1 with a generally well tolerated profile across all doses tested," said Giuseppe Plazzi, Director of the Narcolepsy Center at the IRCCS of the Neurological Sciences of Bologna.

No treatment-emergent serious adverse events were reported, and most side effects were mild to moderate. More than 95% of participants continued into the seven-week open-label extension portion of the study.

Based on these results, Alkermes plans to advance alixorexton to a global phase 3 program. The company will present detailed data from the Vibrance-1 study at the World Sleep Congress in September.

The company is also conducting phase 2 studies of alixorexton in narcolepsy type 2 and idiopathic hypersomnia.

The announcement was based on a press release statement from Alkermes.

In other recent news, Alkermes has drawn attention with its orexin receptor 2 agonist portfolio, specifically the drug candidate ALKS 2680, which is being developed for the treatment of narcolepsy and idiopathic hypersomnia. Goldman Sachs initiated coverage on Alkermes with a Buy rating, highlighting the potential growth from this emerging drug portfolio and setting a price target of $43.00. UBS also upgraded Alkermes from Neutral to Buy, raising the price target to $42.00, citing increased confidence in ALKS 2680’s market positioning. Stifel maintained its Buy rating with a $42.00 target, expressing optimism about the upcoming clinical trial results for ALKS 2680, particularly for narcolepsy type 1 and type 2. Despite these positive outlooks, RBC Capital maintained a Sector Perform rating due to safety concerns related to orexin receptor agonists, pointing out potential risks such as stimulant-like effects and cardiac dysfunction. Analysts from various firms are closely monitoring the results of Alkermes’ clinical trials, which could significantly impact the company’s standing in the sleep disorder treatment market. The anticipated data from these trials are expected to shed light on the efficacy and safety of ALKS 2680, potentially influencing Alkermes’ future growth trajectory. As these developments unfold, investors are keenly watching for any new insights that might emerge from the company’s ongoing research efforts.

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