Callavid intravaginal drug delivery platform selected to advance targeted UTI treatment as part of new programme addressing antibiotic-driven antimicrobial resistance

Calla Lily Clinical Care, a women’s health-focused medical technology company, today announced it has joined Wellcome Leap’s Focused Antibiotics programme – a new $50M funded programme to transform how antibiotics are delivered and address the growing global threat of antimicrobial resistance (AMR).

Founded by Wellcome Trust in 2020, Wellcome Leap is a U.S. non-profit that builds and executes bold, unconventional research programmes designed to increase the number and speed of breakthroughs in human health. The Focused Antibiotics programme aims to leverage innovative technologies to address the unintended effects of antibiotic use, reformulating existing treatment options so they reach the site of infection while sparing the gut microbiome without loss of efficacy.

If left unaddressed, AMR is projected to contribute to over eight million deaths annually by 2050¹. This resistance develops largely through the selective pressure created by antibiotic use. Although 85-90% of infections are localised, nearly all antibiotics are administered systemically, driving gut damage and promoting the emergence and expansion of resistant bacteria. Urinary tract infections (UTIs) are one of the most prevalent outpatient infections worldwide and the most common bacterial infection in women. As a result, women are prescribed almost 40% more antibiotics from the ages of 16 to 54 than men and are therefore disproportionately affected by the downstream systemic effects².

Calla Lily Clinical Care has been selected by Wellcome Leap to evaluate the use of its proprietary Callavid^® drug delivery platform to deliver antibiotics directly via the vaginal wall, bypassing GI transit and first-pass metabolism, and expected to confine systemic exposure to under 5%. Currently, no first-line UTI antibiotic is available in a mass-manufactured vaginal formulation and, if successful, this project will support the programme’s broader objectives of reducing antibiotic-driven resistant infections by up to 40% per year.

Callavid’s patented leak-free, tampon-like design addresses the challenges associated with administration of vaginal therapeutics, enabling cleaner, more comfortable delivery of medicines and hormones. The platform has already achieved important clinical milestones through the National Institute for Health and Care Research (NIHR)-funded FREEDOM trial, which is evaluating vaginal delivery of progesterone using Callavid. Initiated in April 2026³, the study has passed its safety stopping-rule and 90% of patients have completed first round of dosing to date. By evaluating safety, user acceptability and drug absorption, the study aims to demonstrate the platform’s capabilities for maximising overall patient wellbeing and treatment adherence.

Dr Lara Zibners, Co-founder and Chair of Calla Lily Clinical Care, added: “Women are disproportionately impacted by urinary tract infections, yet the consequences of that repeated systemic exposure have been largely overlooked. Organisations such as Wellcome Leap play a vital role in tackling major healthcare challenges through bold innovation. We are honoured to be part of the Focused Antibiotics programme and to explore the potential of Callavid in a foundational antibiotic application, demonstrating how women's health innovations can deliver benefits far beyond fertility and reproductive care.”

Thang Vo-Ta, Co-founder and CEO of Calla Lily Clinical Care, said: “Being selected by Wellcome Leap, one of the world's most ambitious health innovation funders, is a significant validation of what we are building at Calla Lily Clinical Care. Our ambition has always been for Callavid to become the defining platform for intravaginal drug delivery across a wide range of indications. The Focused Antibiotics programme gives us the ideal partner to pursue one of the most consequential of those indications: treating the world's most common bacterial infection in women while helping to address a global resistance crisis that, left unchecked, could claim eight million lives annually by 2050. This marks a pivotal moment in demonstrating that when you solve for women, you solve for everyone.”

The project will be led by Dr Serena de Gelidi, Principal Investigator and R&D Manager at Calla Lily Clinical Care, who holds a PhD in Biomechanical Engineering and brings over thirteen years of medical device research experience, including work on the EU Horizon 2020-funded CRADL device for premature infants. She is supported by Professor Andrew Lewis, Principal Scientist at Calla Lily and an international authority on drug-eluting systems with 58 patents and over 260 peer-reviewed publications.

References:

1. GBD 2021 Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance doi: 10.1016/S0140-6736(24)01867-1.
2. WHO. (2024b). WHO releases guidance on gender inequalities and antimicrobial resistance.
3. Press release (6 May 2026): Calla Lily Clinical Care doses first patients in clinical trial for intravaginal drug delivery platform for threatened miscarriage

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We are honoured to be part of the Focused Antibiotics programme and to explore the potential of Callavid in a foundational antibiotic application, demonstrating how women's health innovations can deliver benefits far beyond fertility and reproductive care.