Huma named for its successful and innovative approach to clinical trials in new UK government review USA - English USA - English

• Huma's innovative approach to medical research cited in Lord James O'Shaughnessy's review for clinical trials improvement in the UK
• The review is part of a new widespread policy approach to ignite the UK's life sciences sector
• Innovating clinical trials using digital technologies such as Huma's platforms can make them more accessible, more diverse, faster to recruit and retain patients

NEW YORK and LONDON, May 25, 2023 /PRNewswire/ -- Huma Therapeutics ("Huma"), a leading global digital health company, is named today as an exemplar of innovation in medical research in an independent review led by former Health Minister, Lord James O'Shaughnessy entitled Commercial clinical trials in the UK.

The review was commissioned by the UK government to make recommendations to improve the clinical trials landscape in the UK. It proposes a range of 'significant actions' to bend the performance curve of trials dramatically, stating: 'The partnership between 2 very different UK life science success stories – AstraZeneca and Huma – shows the potential of the UK in this field'. The review includes a short case study of our joint work¹.

The review proposes that the government doubles the numbers of people taking part in commercial clinical trials in the next two years, and doubles it again by 2027. One of its 27 recommendations is the support and promotion of decentralised clinical trials, which are enabled by digital technology. It calls on stakeholders to develop guidance for decentralised and innovative trials by the end of 2023 to keep pace internationally.

Decentralised clinical trials

An estimated 80% of clinical trials do not meet initial patient enrollment goals and timelines². Decentralised trials can, says the review, increase public involvement in research and new therapies. Data can be collected from the comfort of participants' homes without disrupting their lives, reducing or eliminating the need to travel to clinical trial sites. Retention and adherence to trial protocols through an improved experience can lower the overall cost of research. Decentralised trials also hold the promise of increasing diversity so that new medicines benefit people from all ethnicities and backgrounds.

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Dan Vahdat, Founder & CEO of Huma, said: "As a UK-headquartered company we really want to play our role in supercharging bodies such as the NHS and helping the UK re-establish its leadership position in clinical research. We have the innovative platform and clinical trials expertise to do so: our technology has supported some of the world's largest clinical trials from Covid19 to the Our Future Health study aiming to carry out research on 5 million participants. We join Lord O'Shaughnessy's call for all stakeholders to come together with both a renewed ambition and innovative mindset to bend the performance curve of clinical trials in the UK."

Huma's digital technology platforms support decentralised trials through an easy to configure, end-to-end solution, without hard coding, which allows rapid setup for clinical study requirements. This features pre-built modules including eConsent, ePRO and eCOA that can be adapted to protocols enabling quick setup of therapeutic study requirements.

References:

1. Commercial clinical trials in the UK: the Lord O'Shaughnessy review. Case study: AstraZeneca and Huma partnership
   In March 2022, AstraZeneca, a global, science-led biopharmaceutical company headquartered in the UK, took a step towards harnessing this technology-driven, decentralised clinical trial opportunity through its partnership with Huma Therapeutics, a leading global digital health company also headquartered in the UK.
   
   Huma's technology platform is founded on the first and only disease-agnostic software as a medical device (SaMD) to hold EU Medical Device Regulations (MDR) class IIb certification status. Its adaptations are used on a global scale by more than 1.8 million patients across around 3,000 hospitals and clinics and by more than 650,000 participants across research. Through Huma's primary care division, iPLATO Healthcare, whose digital service is used by 31 million people across the UK, digital technology is also driving recruitment into the UK's largest research programme, Our Future Health, through text messages and push notifications to invite people to join this incredible research programme.
   
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   Partnering with Huma enables AstraZeneca to conduct clinical trials in an entirely new way. For example, a global decentralised study of AstraZeneca's COVID-19 vaccine was designed to allow participants to report data on mobile phones across multiple continents, without ever visiting a trial site. In Germany, Huma and AstraZeneca worked together on a real-world evidence study to identify patients at risk of developing chronic kidney disease, resulting in the potential to recruit 7,000 patients in a single month.
   These are powerful examples of a global pharma leader partnering with a British technology company to show the potential of digital-first care and research.
   
   By combining digital technology with investigational research, AstraZeneca and Huma believe that this innovative approach will deliver marked improvements in the clinical trials space, ultimately resulting in the faster delivery of new and better medicines to patients in the UK and worldwide.
   
2. Johnson, O. (2015). An evidence-based approach to conducting clinical trial feasibility assessments. Clinical investigation, 5, 491-499.

About Huma

Huma Therapeutics is a global digital health technology company that advances digital-first care delivery and research to help people live longer, fuller lives.

Huma's award-winning modular platforms are used by more than 3,000 hospitals and clinics, with 1.8+ million active users in healthcare and 650,000+ participants across research. Huma's regulated Software as a Medical Device is the only platform to hold EU MDR Class IIb regulatory status. It powers:

• Digital first care for health systems
• companion apps to support patients through treatment and drug therapies
• virtual clinical trials to accelerate research

Please visit www.huma.com and follow us on LinkedIn at Huma

Media contact:

Karen Birmingham PhD
Head of PR & Communications, Huma
[email protected]
+44 (0) 7866 609314

Logo: https://mma.prnewswire.com/media/1427908/Huma_Logo.jpg

SOURCE HUMA Therapeutics

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