Calla Lily Clinical Care has dosed the first patients in its Freedom clinical trial, a nihr‑funded study evaluating the company’s Callavid intravaginal drug‑delivery platform for women with luteal phase insufficiency.
The condition, in which progesterone levels may be too low to sustain early pregnancy, is associated with infertility and recurrent miscarriage.
The trial is assessing 400mg progesterone Callavid in patients diagnosed with luteal phase insufficiency. Callavid is positioned as a potential first‑in‑class drug‑device combination for threatened miscarriage and for luteal phase support in assisted reproductive technologies such as IVF.
Estimates cited in the Government’s renewed Women’s Health Strategy suggest the UK sees between 120,000 and 250,000 miscarriages each year. Current NICE guidance recommends 400mg micronised progesterone twice daily for women with a previous miscarriage who present with early‑pregnancy bleeding.
Existing progesterone products rely on pessaries, which can leak, move during use and require patients to remain horizontal after administration. Callavid’s patented, leak‑free, tampon‑like design aims to improve comfort, placement and consistency of drug absorption.
The Freedom study is led by Professor Siobhan Quenby MBE, Clinical Chief Investigator and Honorary Consultant at University Hospitals Coventry and Warwickshire NHS Trust. It will assess safety, user acceptability and progesterone absorption to generate evidence on usability and adherence.
Professor Siobhan Quenby said: ‘Through my clinical practice, I see the difficulties patients face with existing vaginal progesterone products at an already very stressful time. Callavid offers a promising new solution to ensure delivery of the correct progesterone dosage and give women greater confidence in their treatment. There is genuine excitement among both clinicians and patients at the prospect of Callavid progressing into clinical trials.’
Dr Lara Zibners, Co‑founder and Chair of Calla Lily Clinical Care, explained: ‘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.’
Thang Vo‑Ta, Co‑founder and CEO, said: ‘Dosing the first patients in the Freedom study marks a critical milestone for Calla Lily Clinical Care. 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.’
