New Pharmanovia Study Results Reveal Chloral Hydrate Noticeably Improves Severe Insomnia Within Two Weeks

- The RESTORE Trial (An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients With Severe Insomnia) Is a Decentralised Study Using Patient Reported Outcomes (PROs) in a Real-world Setting  - Topline Readout Presented at Sleep Europe Indicates That Chloral Hydrate Significantly Improves Severe Insomnia in Adults Affected by the Disorder After 14 Days of Treatment  - Full Data From the Study to Be Shared in 2025

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Pharmanovia, a global pharmaceutical company that commercialises novel medicines and revitalises the lifecycle of established medicines, today announced positive topline results of its open label RESTORE trial in severe insomnia, in partnership with Lindus Health. A topline readout using patient-reported outcomes (PROs) has found that short-term use of chloral hydrate shows benefit in people with severe insomnia where it is interfering with normal daily life and when other therapies (behavioural and pharmacologic) have failed.

The trial (NCT06053840) enrolled 100 adult patients who received chloral hydrate treatment over 14 days and came from primary and secondary care sites. Patients were closely monitored by a virtual team of secondary care sleep specialists, as part of the decentralised trial design, and were assessed for the safety, tolerability and identification of baseline characteristics, changes in sleep and quality of life outcomes.

The topline readout found that chloral hydrate significantly improved insomnia symptoms in adults with severe insomnia. The primary efficacy endpoint, change in Insomnia Severity Index (ISI) score from baseline after 2 weeks of treatment, decreased significantly after 14 days of treatment and no serious adverse effects were reported. Various patient-reported measures of sleep showed significant improvements in the quality-of-life measures (EQ-5D-5Land RAND-36), and some improvements persisted up to 4 weeks after treatment ended. Sleep quality improvement was seen by a change in Pittsburgh Sleep Quality Index (PSQI) score after 2 weeks of treatment.

These data could mark an important step forward for people living with this condition, as it is estimated that around one in three people live with insomnia, and one in ten have severe forms of the disorder, making this a highly prevalent condition that impacts a person’s quality of life.ⁱ Current standards of care, including behavioural and traditional pharmacologic therapies, do not meet the needs of all people with insomnia, especially those with severe insomnia.

While chloral hydrate is already an established treatment for insomniaⁱⁱ, much of the published clinical data in adult patients is dated. These results have generated fresh data on the efficacy of this treatment, in a real-world setting, using, more current, validated trial endpoints and contemporary quality-of-life measures.

This is the first decentralised trial that Pharmanovia has conducted, in partnership with its clinical trials partner, Lindus Health. The fresh data and insights generated on the safety and efficacy of chloral hydrate, demonstrate the value of real-world evidence (RWE) using patient-reported outcomes. This early analysis of the results is a viable indication of the potential use of chloral hydrate in people with severe insomnia, offering an option where other approaches have failed.

Stephen Deacon, Chief Scientific Officer, Pharmanovia, commented; “We are delighted with the topline results of the RESTORE trial. As a company dedicated to improving health through reinvigorating established medicines and generating new clinical data, we welcome these findings showing that chloral hydrate, an established product licensed for severe insomnia, is effective not just in short-term treatment, but has longer-term benefits after treatment has stopped at 2 weeks, for patients with severe insomnia which is interfering with normal daily life and where other therapies (behavioural and pharmacologic) have failed.”

Professor Adrian Williams, Chief Investigator, Queen Victoria Hospital NHS Foundation Trust commented; “We see lots of barriers to getting patients living with severe insomnia the treatment they need. Today’s study outcomes are a welcome step forward for people living with severe insomnia. The reduction in the severity of insomnia along with improvements in the quality of life demonstrate the effectiveness of chloral hydrate in the treatment of severe insomnia and provides patients with another option when other treatments have failed.”

Michael Young, Co-founder, Lindus Health commented; “The results from the RESTORE trial demonstrate the value and potential of decentralised trial design. By leveraging virtual specialist consultations and web-based patient-reported outcomes, we were able to reach a wider range of people with severe insomnia, providing a more accurate picture of the treatment's effectiveness in a real-world setting. We’re excited to see what’s to come from the full results next year as we look to provide an effective option for people living with severe insomnia."

More details on the trial are available here. Full trial results are expected to be published in 2025.

Notes to editors

About Pharmanovia

Pharmanovia is a global lifecycle management healthcare company. Our purpose is to make medicines fit for tomorrow, to improve the lives of patients globally.

We do this by rediscovering, repurposing or re-engineering established medicines to improve patient outcomes and experiences.

With a diverse and growing team in over 160 countries across the globe, we deliver high-quality solutions, ethically and sustainably, across our four core therapeutic areas – Endocrinology, Neurology, Cardiovascular and Oncology.

About Lindus Health

Lindus Health is a London-based start-up, launched in 2021, that runs clinical trials three times faster than the old-fashioned industry standard – bringing ground-breaking treatments to patients more quickly.

Clinical trials are the biggest bottleneck to advances in healthcare and by removing this constraint we aim to improve health for everyone. Lindus does this by using its pioneering industry-first platform that can manage a trial from start to finish.

Lindus Health has to date delivered more than 80 trials across the UK, US and Europe to tackle a range of conditions including diabetes, asthma, acne, social anxiety, major depressive disorder, hypertension, chronic fatigue syndrome and insomnia.

The company was named after James Lind, who pioneered the first clinical trial and treatment for scurvy, and co-founded by Michael Young, a former No 10 Special Adviser on Life Sciences, and Meri Beckwith, a former biotech investor.

The company has raised $24.5m from investors including Peter Thiel, CREANDUM, Firstminute Capital, Presight Capital, Seedcamp, Hambro Perks, Amino Collective and Calm/Storm.

For more information about Lindus Health please visit www.lindushealth.com

References

ⁱ Insomnia (1BC) NHS inform. Available at: https://www.nhsinform.scot/illnesses-and-conditions/mental-health/insomnia/#:~:text=Insomnia%20is%20difficulty%20getting%20to,particularly%20common%20in%20elderly%20people. (Accessed: 04 September 2024).

ⁱⁱ Johns, M.W. Sleep and Hypnotic Drugs. Drugs 9, 448–478 (1975).

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