Calla Lily Clinical Care secures UK NIHR funding for progesterone device trial

Researchers trialing a progesterone delivery device for miscarriage prevention say the technology could help over 150,000 women in the UK each year.

The study — for which developer Calla Lily Clinical Care secured £1 million in funding from the UK National Institute for Health and Care Research (NIHR) — will be carried out by a team at the University Hospitals Coventry and Warwickshire NHS Trust.

Calla Lily co-founder and CEO Thang Vo-Ta told Clinical Insider, “Both UHCW and University of Warwick are collaborators on the NIHR-funded project that includes this first clinical trial.

“It was always envisaged that this trial would be run at UHCW in conjunction with their significant clinical trials experience, rather than using a CRO [clinical research organization],” he added.

Trial participants will be non-pregnant luteal phase insufficiency patients recruited from a clinic run by Siobhan Quenby, professor, director of the biomedical research unit at the University of Warwick.

For future clinical studies of the device, Calla Lily is likely to seek an external CRO, Vo-Ta said.

“Our expectation is that a subsequent bioequivalence trial would require a different population of participants, most likely post-menopausal healthy volunteers, as this is an established population for establishing bioequivalence of vaginally delivered progesterone products.

“For this bioequivalence trial we would most likely look to be supported further by a CRO,” he added.

Current therapies

The device — called Callavid — is designed to improve the delivery of progesterone to women at risk of miscarriage, referred to as “threatened miscarriage.”

Current UK prevention guidelines for miscarriage are doses of vaginal micronized progesterone with treatment usually being self-administered via pessaries.

However, the self-administration method is prone to significant leakage, which can cause substantial anxiety and inconvenience for patients, according to Calla Lily.

DepositPhotos/kikkerdirk