Calla Lily Clinical Care doses first patients in miscarriage treatment trial
Evaluating new intravaginal drug delivery platform for progesterone treatment
Calla Lily Clinical Care has dosed the first patients in a new clinical trial evaluating its intravaginal drug delivery platform for progesterone treatment in threatened miscarriage.
The NIHR-funded FREEDOM study is testing Callavid®, the company’s tampon-like drug delivery device, in women with luteal phase insufficiency - a condition where progesterone levels may be too low to support early pregnancy, increasing the risk of infertility and recurrent miscarriage.
Progesterone is already recommended by NICE for women who experience bleeding in early pregnancy after a previous miscarriage. However, current vaginal pessaries can leak, shift position and be uncomfortable to use, with some patients advised to remain lying down after administration.
Calla Lily says its leak-free device is designed to improve comfort, consistency and absorption of progesterone treatment.
Dr Lara Zibners, co-founder and Chair of Calla Lily Clinical Care, added: “As a physician and entrepreneur, I believe we have a responsibility to create more effective, patient-centered solutions in women’s health.
“Having been through seven rounds of IVF myself, I have experienced how difficult progesterone treatment can be, and I am proud to be advancing an innovation shaped by both medical insight and lived experience.”
The trial is being led by Professor Siobhan Quenby at University Hospitals Coventry and Warwickshire NHS Trust and will evaluate safety, usability and progesterone absorption.
“Through my clinical practice, I see the difficulties patients face with existing vaginal progesterone products at an already very stressful time,” said Professor Quenby. “
Callavid offers a promising new solution to ensure delivery of the correct progesterone dosage and give women greater confidence in their treatment.”
The Government’s Renewed Women’s Health Strategy for England cites estimates ranging from 120,000 to 250,000 cases of miscarriage per year in the UK. Administering 400mg micronised progesterone twice daily is recommended by the National Institute for Health and Care Excellence (NICE) for women who have suffered a previous miscarriage and experience bleeding during early pregnancy, known clinically as ‘threatened miscarriage’.
However, Calla Lily’s Callavid could eventually support a broader range of women’s health treatments, including IVF and other assisted reproductive technologies.
Thang Vo-Ta, Co-founder and CEO of Calla Lily Clinical Care, said: “Callavid represents a differentiated delivery modality for a broad range of therapeutics in the pharma pipeline, and will create new opportunities to extend the lifecycle of existing drugs. This trial is a key step in demonstrating Callavid’s massive potential.”