Women’s health medical technology company Calla Lily Clinical Care has dosed the first patients in the Freedom clinical trial. The study is evaluating 400mg progesterone Callavid in patients diagnosed with luteal phase insufficiency.
“Dosing the first patients in the FREEDOM study marks a critical milestone for Calla Lily Clinical Care,” said Thang Vo-Ta, Co-founder and CEO of 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.”
Luteal phase insufficiency is a condition where the ovaries produce too little progesterone to support early pregnancy, increasing the risk of infertility and recurrent miscarriage. Luteal phase insufficiency appears in 23%-60% of cases where women experience recurrent pregnancy loss. 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.
The National Institute for Health and Care Excellence recommends 400mg for women who have suffered previous miscarriage and experience bleeding during early pregnancy. However, currently delivery methods rely on self-administration using pessaries, which are prone to leakage and may result in uncertain placement and movement during use. These limitations can reduce the efficiency and consistency of drug absorption.
Callavid offers an alternative solution, designed to be leak-free and simpler to administer through a tampon-like design. This design enables a cleaner, more comfortable delivery of medicines and hormones.
“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,” said clinical chief investigator professor Siobhan Quenby MBE, who is leading the study.
The study is led by clinical chief investigator professor Siobhan Quenby MBE and funded by the National Institute for Healthcare and Research. It is run collaboratively with the Trial Management Unit at University Hospital Coventry and Warwickshire.
