Summary: Alkermes plc introduced plans to present 3 posters at Rest 2024, showcasing the probable positive aspects of its investigational orexin 2 receptor agonist, ALKS 2680, for narcolepsy therapy. Displays will consist of information from a period 1b research, the layout of the period 2 Vibrance-1 demo, and insights from patient interviews highlighting the influence of narcolepsy on daily lifetime.
Vital Takeaways:
- Phase 1b Examine Knowledge: The phase 1b study evaluated the safety and efficacy of a solitary-dose oral administration of ALKS 2680 in individuals with narcolepsy sort 1, utilizing both equally aim and subjective measures.
- Vibrance-1 Trial Design and style: The phase 2 Vipbrance-1 trial will assess the security and efficacy of ALKS 2680 in a larger sized cohort of people with narcolepsy sort 1, in contrast to a placebo.
- Client Interviews: Qualitative interviews with people with narcolepsy kinds 1 and 2 uncovered the intensive impression of the problem on several areas of their life, which includes work, school, psychological overall health, day-to-day things to do, and associations.
Alkermes plc introduced plans to present 3 posters relevant to ALKS 2680—the company’s novel, investigational, oral orexin 2 receptor (OX2R) agonist in advancement as a after-day by day treatment for narcolepsy—at Sleep 2024 in Houston.
The organization will current two posters all through a late-breaking summary session:
- Data from the complete cohort of individuals (n=10) with narcolepsy form 1 from the period 1b, a evidence-of-principle examine analyzing single-dose oral administration of ALKS 2680. Basic safety effects and pharmacodynamic efficacy assessments analyzing goal (Maintenance of Wakefulness Test) and subjective affected individual-documented (Karolinska Sleepiness Scale) measures of sleepiness will be presented.
- Review layout and methods for the Vibrance-1 analyze, a lately initiated period 2 medical demo analyzing the safety and efficacy of ALKS 2680 when compared to placebo in sufferers with narcolepsy variety 1.
In addition, conclusions from in-depth, qualitative interviews with individuals with narcolepsy variety 1 (n=12) and narcolepsy variety 2 (n=10) will be presented. During the 60-minute interviews, individuals explained the influence and burden of sickness on many sides of their life, including function and faculty routines, psychological overall health, things to do of day by day residing, and associations.
“We have designed important progress in the ALKS 2680 plan in the last year, such as making proof-of-concept details that validated our structure speculation and enabled us to initiate our Vibrance-1 period 2 review in clients with narcolepsy variety 1,” states Craig Hopkinson, MD, main medical officer and govt vice president of investigate and development at Alkermes, in a launch. “We are energized to present data from the full narcolepsy variety 1 cohort from our phase 1b examine and qualitative findings that carry to light new insights from people that show the breadth of impacts narcolepsy can have on patients’ life. We seem forward to partaking with the snooze group at this significant scientific conference.”
Research Information
Information of Alkermes’ displays at Slumber 2024 are as follows:
“Safety and pharmacodynamic effects of the orexin 2 receptor agonist ALKS 2680 in sufferers with narcolepsy form 1: a initially-in-human stage 1 study”
- Abstract ID: 1323
- Poster board variety: 423
- Presenter: Ron Grunstein, MD, PhD, head of sleep and circadian exploration at the Woolcock Institute of Health care Research
- Presentation day: The poster will be offered on Tuesday, June 4, from 10–10:45 am CT, through session P-31.
“Vibrance-1: Study layout and strategies for a phase 2, randomized, placebo-managed, parallel team examine analyzing the protection and efficacy of ALKS 2680 in clients with narcolepsy sort 1”
- Abstract ID: 1363
- Poster board quantity: 462
- Presenter: David T. Plante, MD, PhD, Associate Professor of Psychiatry at the College of Wisconsin-Madison
- Presentation date: The poster will be presented on Tuesday, June 4, from 11–11:45 am CT, all through session P-31.
“The stress of dwelling with narcolepsy: affected individual perspectives from in-depth qualitative interviews”
- Summary ID: 673
- Poster board selection: 302
- Presenter: Michael J. Doane, PhD, Alkermes
- Presentation day: The poster will be offered on Wednesday, June 5, from 11–11:45 am CT, through session P-42.
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