‘No going back’ for clinical trials after COVID

Trial sites have adapted swiftly to the restrictions of COVID-19, and patients have seen many knock-on benefits as a result. The next step is ensuring the industry does not regress to old ways of working once the pandemic is over, say Karen McIntyre and Allyson Small.

COVID-19 has changed everything for clinical trials – but in most cases these are changes that were well overdue.

“For years and years, the industry has debated the practicalities and safety of decentralising clinical trials, using telemedicine, and where study activities should take place,” says Karen McIntyre, executive director, global lead Catalyst Program & site relationships at Syneos Health. “We were always having these discussions, but nothing moved forward.”

When the pandemic hit, regulators around the world rapidly updated their guidelines to reflect the realities of conducting trials amidst lockdowns and social distancing mandates.

“For example, drugs are now able to be delivered directly to patients to allow for a clinical trial visit to take place remotely,” says McIntyre.

• Read the full article in pharmaphorum’s Deep Dive digital magazine

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Sensyne launches fundraising, agrees patient data deal with Phesi

UK digital health firm Sensyne has secured access to millions more anonymised patent records via an alliance with US clinical trial data specialist Phesi.

The new agreement comes after a string of access deals with NHS trusts for patient data, and coincides with a bid by Sensyne to raise £27.5 million (around $37 million) through a 90 pence per share placing.

The proceeds of that round – and possibly a second £2.5 million open offer that is also planned – will go towards “industrialising” its big data analytics and clinical artificial intelligence (AI) platform, with £10 million going towards buying a 10% equity stake in Phesi.

Oxford-based Sensyne uses patient data to improve drug development, disease understanding and clinical trial design, as well as to discover new drug targets, and also develops digital health software applications powered by AI such as GDm-Health for diabetes and CVm-Health for COVID-19.

Another £10 million from the fundraising will go towards building Sensight – a real-world, pharmaceutical R&D platform intended to analyse data more rapidly and cost effectively – while £6.5 million is earmarked for development of its Sense clinical AI engine for healthcare providers and payers.

“Currently, responding to questions about available categories of Sensyne’s data can take several weeks with clinical AI answers taking months to produce,” says the company’s fundraising prospectus.

“Investments into industrialising this process are expected to dramatically reduce these timescales to seconds and weeks,” it goes on.

It already has access to around 6.1 million UK patient health records – equivalent to around 10% of the country’s total population – and the new agreement with Phesi will add around 13.5 million international patient records from 320,000 clinical trials dating back to 2007.

Phesi provides Sensyne with the benefit of a different type of data set, according to Sensyne, namely anonymised clinical trials data and clinical investigator site information.

Once the transactions go through, Sensyne and Phesi will work together to offer “synthetic” clinical trial arms and clinical decision support tools combining trial and real world data, for an initial period of five years.

Sensyne’s approach has already resulted in several agreements with major pharmaceutical and biotechnology companies including Bayer, Roche, Alexion and Bristol-Myers Squibb, while Phesi also has “a strong list of clients having worked with multiple blue-chip pharmaceutical and biotechnology companies.”

Peel Hunt and Liberum Capital Limited are acting as joint bookrunners for the placing.

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Sensyne launches fundraising, agrees patient data deal with Phesi

UK digital health firm Sensyne has secured access to millions more anonymised patent records via an alliance with US clinical trial data specialist Phesi.

The new agreement comes after a string of access deals with NHS trusts for patient data, and coincides with a bid by Sensyne to raise £27.5 million (around $37 million) through a 90 pence per share placing.

The proceeds of that round – and possibly a second £2.5 million open offer that is also planned – will go towards “industrialising” its big data analytics and clinical artificial intelligence (AI) platform, with £10 million going towards buying a 10% equity stake in Phesi.

Oxford-based Sensyne uses patient data to improve drug development, disease understanding and clinical trial design, as well as to discover new drug targets, and also develops digital health software applications powered by AI such as GDm-Health for diabetes and CVm-Health for COVID-19.

Another £10 million from the fundraising will go towards building Sensight – a real-world, pharmaceutical R&D platform intended to analyse data more rapidly and cost effectively – while £6.5 million is earmarked for development of its Sense clinical AI engine for healthcare providers and payers.

“Currently, responding to questions about available categories of Sensyne’s data can take several weeks with clinical AI answers taking months to produce,” says the company’s fundraising prospectus.

“Investments into industrialising this process are expected to dramatically reduce these timescales to seconds and weeks,” it goes on.

It already has access to around 6.1 million UK patient health records – equivalent to around 10% of the country’s total population – and the new agreement with Phesi will add around 13.5 million international patient records from 320,000 clinical trials dating back to 2007.

Phesi provides Sensyne with the benefit of a different type of data set, according to Sensyne, namely anonymised clinical trials data and clinical investigator site information.

Once the transactions go through, Sensyne and Phesi will work together to offer “synthetic” clinical trial arms and clinical decision support tools combining trial and real world data, for an initial period of five years.

Sensyne’s approach has already resulted in several agreements with major pharmaceutical and biotechnology companies including Bayer, Roche, Alexion and Bristol-Myers Squibb, while Phesi also has “a strong list of clients having worked with multiple blue-chip pharmaceutical and biotechnology companies.”

Peel Hunt and Liberum Capital Limited are acting as joint bookrunners for the placing.

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Sensyne Health launches diabetes app in the UK

UK digital health company Sensyne Health has launched a new smartphone app to help people across the diabetes spectrum manage their condition.

The app – called DBm-Health – can help users to monitor their blood glucose levels and send readings, notes and medication information to their healthcare practitioner to assess remotely.

It is a follow-on to Sensyne’s GDm-Health product, which is used for remote monitoring of diabetes during pregnancy and was recently made available for free to all NHS Trusts in the UK for one year to assist with monitoring and managing this high-risk group during the COVID-19 pandemic.

GDm-Health has been a success since launch, says the company, which claims a market share of 47% across all NHS Trusts in England. That has prompted the company to accelerate the roll-out of DBm-Health for the wider diabetic community.

Other uses for DBm Health include cancer patients with pre-diabetes, who are known to be at elevated risk of developing full-blown diabetes if they are given high-dose steroid treatment.

It could also help patients with diabetes who are shielding in order to reduce their risk of coronavirus infection – which is important as diabetics are thought to be more vulnerable to severe COVID-19 than non-diabetic people.

There is also evidence suggesting COVID-19 may trigger the onset of diabetes in healthy people and cause poor control for existing diabetes sufferers. Sensyne recently launched a web-based app, CVm-Health, to assist individuals in monitoring coronavirus symptoms.

The new app will be piloted in three NHS Trusts over the next few months, to see if it provides the promised health-economic and operational benefits, and is also due to be launched in the US later this year as part of Sensyne’s push for overseas expansion.

Sensyne says that unlike other diabetes apps, DBm-Health provides a patient’s clinician with information on their status and whether any additional treatment may be required.

Managing the 3.9 million people living with diabetes costs the NHS around £9.8 billion a year, according to the charity Diabetes UK. There are also more than 34 million people with diabetes in the US, adding $327 billion to the cost of healthcare.

In light of the coronavirus crisis, the NHS has moved rapidly to offer remote consultations, particularly for those with co-morbidities such as diabetes which puts a person at particular risk of severe infection.

“We are responding to the urgent need of NHS Trusts for new digital technologies to optimally care for patients with diabetes,” commented Dr Lucy Mackillop, Sensyne’s chief medical officer.

“DBm-Health will help ensure the highest quality information is securely available to clinicians from patients who are particularly vulnerable to COVID-19 and are advised to stay at home during the pandemic,” she added.

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