Alkermes plc ALKS announced the initiation of the phase II Vibrance-2 study, evaluating its novel, investigational, oral orexin 2 receptor agonist ALKS 2680 in adults with narcolepsy type 2 (NT2).
The double-blind, placebo-controlled study will evaluate the safety and efficacy of ALKS 2680 as compared to placebo in adults with NT2. The primary endpoint of the Vibrance-2 study will check whether treatment with ALKS 2680 leads to a greater decrease in sleepiness versus placebo, as measured by the change in mean sleep latency on the maintenance of wakefulness test (MWT).
In the study, participants will be randomized to receive one of the three doses of ALKS 2680 (10 mg, 14 mg or 18 mg) or placebo to be taken once daily for eight weeks.
Secondary endpoints of the Vibrance-2 study are change in Epworth Sleepiness Scale score and the incidence of adverse side effects.
Shares of Alkermes have increased 0.9% so far this year compared with the industry's rise of 1.6%.
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ALKS initiated the Vibrance-2 study following the success of the phase Ib proof-of-concept study, which evaluated ALKS 2680 for treating narcolepsy.
The company announced positive top-line data from the phase Ib study evaluating ALKS 2680, as a once-daily treatment for narcolepsy in April 2024. The data was from the NT2 and idiopathic hypersomnia cohorts of the early-stage proof-of-concept study, which evaluated various doses of ALKS 2680 (5 mg, 12 mg and 25 mg) for the given indication.
Data from the study showed that treatment with ALKS 2680 led to clinically meaningful and statistically significant improvements in mean sleep latency on the MWT versus placebo from baseline at all doses tested.
We note that the phase II Vibrance-1 study is investigating ALKS 2680 in adults with narcolepsy type 1 (NT1). If successfully developed and upon potential approval, ALKS 2680 can serve an area of high unmet medical need in the treatment of NT1 and NT2.
However, upon potential approval, ALKS 2680 is likely to face competition from Axsome’s AXSM Sunosi (solriamfetol), which is presently marketed in the United States for the treatment of narcolepsy.
Axsome acquired the U.S. rights to Sunosi from Jazz Pharmaceuticals JAZZ in May 2022. AXSM began selling Sunosi in the U.S. market in May 2022.
JAZZ received approval for Sunosi as a treatment for narcolepsy in 2019.
Jazz’s other sleep disorder drugs, Xyrem and Xywav, also hold a strong market share.
Zacks Rank & Stock to Consider
Alkermes currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the biotech sector is Fulcrum Therapeutics, Inc. FULC, sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.51. Year to date, shares of FULC have surged 30.2%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
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