Closed Loop Medicine announces positive outcome of a key clinical drug study required for regulatory submission of its ‘drug plus digital’ insomnia product CLM-IN01

London, UK, 04 August 2021: Closed Loop Medicine Ltd, a healthcare company focused on developing drug + digital combination products, the next generation of patient centric pharmaceutical products, reports positive regulatory clinical data for its insomnia drug, ahead of regulatory submission of its combination product CLM-IN01 for insomnia. 

 The study, a single-dose, open-label, randomized trial in healthy subjects met its primary and secondary endpoints for a new 2mg prolonged-release capsule formulation. This formulation was developed together in collaboration with Closed Loop Medicine’s partner Orient Pharma. Orient Pharma are a Taiwan based multinational pharmaceutical, healthcare and consumer products company having formed a strategic partnership with Closed Loop Medicine in 2017.

The global sleep economy is expected to grow to $585 billion by 2024, yet very few solutions for insomnia are helping people sleep better. Insomnia is a condition that afflicts 10-15% of the adult population and is often a further complication in certain neurodegenerative conditions such as Alzheimer’s and Parkinson’s disease, as well as in cancer, anxiety, depression and during menopause. 

The combination products being developed by Closed Loop Medicine will transform a patient’s care by integrating drug therapy and digital care solutions. The software component of the combination therapy recently received UKCA  (UK Conformity Assessed) and CE designation for Europe. The UKCA marking applies to products previously subject to  CE marking.

The results from this study and the recent UKCA and CE marking means that the company is on track to submit what will be a first in class novel combination product linking a known drug with SaMD under a single prescription for the treatment of Chronic Insomnia Disorder to regulators for review and consideration for market authorisation.

Through this product the company aims to better support patients with insomnia by providing greater access to an integrated care package of both drug and non-drug therapy which delivers precision personalised therapy through a patient centric product.

Dr Mike Taylor, Vice President, Clinical Development commented: “I am delighted that we were able to achieve this positive result and important company milestone, on time and to budget, despite all of the constraints during the Covid-19 pandemic”

Dr Hakim Yadi OBE, Chief Executive Officer commented: “This has been a team effort, working under extraordinary conditions to allow us to validate the drug component of our lead combination drug + SaMD product, the results from this study put us on track for regulatory submission of a first in class combination therapy for insomnia. We aim to support patients find a path back to normal sleep, this result helps us get there“. 

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