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Company of the Month: Closed Loop Medicine

Closed Loop Medicine is a healthcare company developing personalised digital healthcare solutions to improve outcomes for patients and clinicians. We spoke to CEO Dr Hakim Yadi OBE about the company’s innovative approach to personalised healthcare and his passion for health innovation research.

Following a pharmaceutical industrial placement during his undergraduate biology studies, Hakim completed a PhD at the Babraham Research Campus in Cambridge. He went into management consultancy, helping to commercialise new technologies and innovations for health care, and worked extensively with UK government, before running the Northern Health Science Alliance.

He co-founded Closed Loop Medicine to bring together the different care modalities at the forefront of personalised medicine: drugs, digital and devices.

Precision care

A key area of interest for Closed Loop Medicine are diseases for which drugs are not routinely dose-optimised. For these diseases, there is the potential to refine and tailor drug dosing by harnessing real-world data, collected from an individual through a digital therapeutic device.

“What we are doing at Closed Loop Medicine is bringing to market combination products that link drugs with software as a medical device and digital therapeutics (DTx). We want to close the loop on the dialogue between the patient and the clinician. At the same time, we are closing the loop on the two aspects of care we are most interested in: drug-based therapy and non-drug, behavioural and lifestyle interventions.”

One target is hypertension and a product in the Closed Loop Medicine pipeline combines a software product with a personalised dosing regimen for an anti-hypertensive drug. A clinical study is underway with Queen Mary University of London and Bart’s Health NHS Trust.

The company is focused on using data and technology to provide the right dose of the product at an individual level. The variability of individual therapeutic windows has largely been unaddressed by both the pharmaceutical industry and the clinical community. Through ‘drug plus DTx’ combination products this problem can be solved, impacting on safer and more effective treatment of many diseases.

Bringing biology and behaviour change together

The most advanced product in the Closed Loop Medicine pipeline is CLM-IN01, designed to address insomnia. A clinical trial of the product reported data in August and it is now being prepared for regulatory submission.

“CLM-IN01 is about supporting a patient to better understand their sleep patterns, better educating them on healthy behaviours before and in bed, and then linking that to the optimum time their medication should be taken.

One of the company’s co-founders, Dr Paul Goldsmith, President and Chief Innovation and Medical Officer, is a clinician who understands the challenges of treating insomnia. Patients may be prescribed various drugs for insomnia, but optimising how to they are taken and judging whether they are working is difficult and patients also need support with behaviour and lifestyle changes. Closed Loop Medicine aims to take a holistic approach to drug optimisation.

“The drug and software elements are inextricably linked; it’s all on the same prescription. This will be regulated as a single combination product. When the patient picks up the prescription, they will get access to both the software and the drug and we’ll use the data they record to personalise their drug regimen.”

A step into the future

Other companies have produced drugs for insomnia and many digital health products exist for people with insomnia. Where Closed Loop Medicine is really different is in its determination to provide patients and physicians with a package of both drug and non-drug support. For regulators, this is a new and interesting challenge.

“As far as we’re aware, as a combination product, this would be a ‘first in class’ for insomnia. The next big step for us is to work with the regulators in understanding how you regulate such a combination product. I’m really pleased to say that the MHRA [Medicines and Healthcare products Regulatory Agency] here in the UK has been absolutely incredible to work with. They are totally focused on the patient, and looking to reconcile the conundrum of getting both more innovative products and safer products to patients through the use of data.”

Closed Loop Medicine plans to work towards regulatory submission and hopefully a successful marketing authorisation of the product in the UK, before moving on to work with other countries and regions.

The importance of life sciences clusters

Hakim has been involved with MedCity since the very beginning, as part of the team that wrote its original business case. He has a strong understanding of and commitment to the concept of life sciences clusters, deepened during his time at the Northern Health Science Alliance (NHSA).

“At NHSA, I spent a lot of time working on understanding the role of clusters in supporting innovation, making connections, and shining a light on the great clinical academic research that goes on in the UK. I’m now chairman of HIRANI, the Health Innovation Research Alliance Northern Ireland, and still very supportive of the clusters of the UK.”

His existing connection to the UK’s life sciences clusters meant that when Hakim moved to set up Closed Loop Medicine, he knew the type of support available to the company.

“With my Closed Loop Medicine hat on, I’ve been able to come to MedCity for help and connections to commercial expertise and to people who could support our development, particularly during the COVID pandemic, where there was so much disruption to clinical trials. MedCity also supported us around fundraising, in connecting us with the activity of the Angels in MedCity, and in helping us to think through appropriate investors for us.”

The company has recently closed £13 million of new investment. Funding came from Ananda Impact Ventures, LifeArc, Meltwind, and Downing Ventures alongside existing investors BGF, Longwall, IQ Capital and Cambridge Angels.

At home in London and Cambridge

Closed Loop Medicine has its registered office in Cambridge and the Babraham Research Campus has been a major part of its development, but London has also been key. With London’s pool of talent in software development, engineering and design, it is at the heart of digital therapeutics.

During COVID-19, the company moved to a virtual model, supporting staff to work remotely, and this has started a conversation about how best physical space might be used as they evolve to a hybrid model.

“If you want to do ‘high-risk work in a low-risk environment’, you need to be in a cluster. Where we are very fortunate is that we can tap physically into two clusters, London and Cambridge, and virtually into many more.”

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