DUBLIN - Alkermes plc (NASDAQ:ALKS) announced promising results from a phase 1b study of its investigational drug ALKS 2680, showing significant improvements in wakefulness for patients with narcolepsy type 2 and idiopathic hypersomnia. The study demonstrated that ALKS 2680, an oral orexin 2 receptor agonist, improved mean sleep latency compared to placebo at all doses tested.
The trial included small cohorts for both conditions, with nine patients for narcolepsy type 2 and eight for idiopathic hypersomnia. Each participant received different doses of ALKS 2680 and a placebo in a crossover design. The drug was well tolerated, with most treatment-emergent adverse events being mild and self-resolving. Notably, no serious adverse events or events leading to discontinuation were reported.
In the narcolepsy type 2 cohort, ALKS 2680 showed a dose-dependent increase in mean sleep latency, with the highest dose resulting in a 21-minute improvement. Similarly, patients with idiopathic hypersomnia experienced up to an 18-minute increase in wakefulness at the highest dose tested.
Ron Grunstein, M.D., Ph.D., from the Woolcock Institute of Medical Research, noted the potential of orexin 2 receptor agonists like ALKS 2680 to treat sleep disorders, even in patients without known orexin deficiency. Alkermes' Chief Medical Officer, Craig Hopkinson, M.D., expressed the company's intention to proceed with a phase 2 study in the second half of the year, based on the positive data.
The phase 1 study also included evaluations in healthy volunteers and patients with narcolepsy type 1. Alkermes plans to publish the full results in a peer-reviewed journal and present additional data at upcoming scientific meetings.
Alkermes is a global biopharmaceutical company focused on developing treatments for neurological disorders, with a portfolio that includes commercial products for alcohol dependence, opioid dependence, schizophrenia, and bipolar I disorder. The company is headquartered in Dublin, Ireland, with additional facilities in the United States.
This news is based on a press release statement from Alkermes plc.
InvestingPro Insights
As Alkermes plc (NASDAQ:ALKS) continues to make strides in the development of treatments for neurological disorders, including their latest investigational drug ALKS 2680, the company's financial health and market performance offer additional insights. According to InvestingPro data, Alkermes boasts a robust market capitalization of approximately $4.39 billion USD. This is underpinned by a strong gross profit margin of 84.79% over the last twelve months as of Q4 2023, reflecting the company's ability to efficiently manage its cost of goods sold and maintain profitability.
Investors may also find the company's valuation compelling, as the adjusted P/E ratio as of Q4 2023 stands at a relatively low 8.32, suggesting that the stock might be undervalued compared to earnings. Additionally, the revenue growth for the same period was an impressive 49.61%, indicating a significant increase in the company's ability to generate income.
Two InvestingPro Tips that may be of interest to investors include Alkermes' financial stability, with the company holding more cash than debt on its balance sheet, and the prediction by analysts that the company will be profitable this year. These factors could provide confidence in the company's financial management and future prospects.
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