LONDON, United Kingdom – May 6, 2026
Calla Lily Clinical Care has announced dosing of the first patients in the FREEDOM clinical trial, a key milestone for the company’s proprietary Callavid® intravaginal drug delivery platform designed to improve progesterone administration in women experiencing threatened miscarriage and fertility complications. The NIHR-funded study, conducted in collaboration with University Hospitals Coventry and Warwickshire NHS Trust, is evaluating 400mg progesterone Callavid in women diagnosed with luteal phase insufficiency, a condition linked to infertility and recurrent miscarriage due to inadequate progesterone levels during early pregnancy. The trial marks a significant step forward for the company’s strategy to develop the world’s first progesterone drug-device combination product focused on threatened miscarriage prevention and IVF luteal phase support.
Callavid Targets Major Limitations in Current Progesterone Delivery
Current progesterone treatments used during fertility support and early pregnancy commonly rely on vaginal pessaries or suppositories, which are associated with leakage, inconsistent placement, discomfort, and variable drug absorption. These limitations can negatively affect treatment adherence and potentially compromise therapeutic outcomes during a highly stressful period for patients.
Calla Lily’s Callavid platform was developed specifically to address these challenges through a patented leak-free, tampon-like delivery system designed to improve comfort, usability, and dosing consistency. The company believes the platform can significantly enhance patient experience while improving effective progesterone absorption and reducing uncertainty around drug administration. Importantly, the technology also eliminates the need for patients to remain lying down for prolonged periods after administration, a common recommendation with current therapies.
FREEDOM Study Evaluates Safety, Usability, and Drug Absorption
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The FiRst in human safEty and Ease of use assessment of 400mg progesterone CallaviD in wOMen with luteal phase insufficiency (FREEDOM) study is being led by Professor Siobhan Quenby MBE, a globally recognized expert in miscarriage and preterm birth research. The trial will assess the safety profile, patient usability, acceptability, and progesterone absorption characteristics of the Callavid system in women with luteal phase insufficiency. Researchers aim to generate evidence demonstrating improved patient adherence and overall wellbeing through easier self-administration.
The study is particularly relevant given the significant burden of miscarriage in the UK, where government estimates suggest between 120,000 and 250,000 miscarriages occur annually. Current NICE guidelines recommend progesterone therapy for women with previous miscarriage history who experience bleeding during early pregnancy, highlighting the importance of more effective and patient-friendly delivery technologies.
Platform Potential Extends Beyond Fertility and Pregnancy
While the company’s immediate focus is fertility and threatened miscarriage, Calla Lily sees broader commercial opportunities for the Callavid platform across multiple therapeutic areas. According to the company, the delivery technology has potential applications in oncology, menopause, infectious diseases, and live biotherapeutics, including therapies aimed at reducing antibiotic use and antimicrobial resistance.
The platform could also provide pharmaceutical partners with a differentiated delivery solution capable of extending the commercial lifecycle of established or off-patent drugs. CEO and co-founder Thang Vo-Ta described the first patient dosing as a critical milestone that validates the broader strategic potential of the platform within women’s health and pharmaceutical delivery innovation.
Women’s Health Innovation Gains Industry Attention
Calla Lily Clinical Care’s advancement reflects growing investment and innovation in the women’s health sector, particularly in areas historically underserved by pharmaceutical and medical technology companies. Co-founder and Chair Dr Lara Zibners, who personally underwent multiple IVF cycles, emphasized the need for more patient-centered treatment solutions that address both medical effectiveness and real-world usability.
As healthcare systems increasingly prioritize women’s health initiatives and fertility care accessibility, technologies that improve treatment adherence and patient comfort may gain significant clinical and commercial traction. If successful, the Callavid platform could establish a new standard for intravaginal therapeutic delivery and create a scalable opportunity across multiple drug categories.
Source: Calla Lily Clinical Care press release
