Fondazione Penta is pleased to be part of a new international clinical development programme led by Enanta Pharmaceuticals, a clinical-stage biotechnology company, to advance zelicapavir, a new oral antiviral in development for the treatment of respiratory syncytial virus (RSV), one of the leading causes of respiratory illness in young children worldwide.
The programme includes the launch of a paediatric phase 2 clinical trial in Thailand in the third quarter of 2026, with topline results expected in 2027. This study represents an important step towards expanding treatment options for a disease that continues to pose a significant global health burden for children.
Within this programme, Penta collaborates with Enanta Pharmaceuticals and the AMS‑PHPT Research Unit at Chiang Mai University, combining complementary expertise in paediatric infectious diseases and clinical trial implementation.
“Bringing together international partners and clinical sites is essential to accelerate the generation of evidence that can truly make a difference for paediatric patients worldwide,” said Carlo Giaquinto, the President of Fondazione Penta.
Study meeting in Chiang Mai
In June 2026, a study meeting was held in Chiang Mai, Thailand, bringing together investigators and study teams from all participating sites. This meeting represented a key milestone in the preparation phase of the trial, ensuring alignment across partners on study procedures, timelines and operational aspects ahead of study initiation.
The meeting also provided an opportunity to strengthen collaboration across the international network involved in the study and to confirm the shared commitment to delivering high‑quality research in paediatric populations.
“The study meeting in Chiang Mai marked an important milestone for the trial and highlighted the strong collaborative spirit of site and study teams driving this important research programme,” said Tim R. Cressey, co‑Principal Investigator.
About the Phase 2 study
The Phase 2 study is a multicentre, randomised, double‑blind, placebo‑controlled trial designed to evaluate the efficacy and safety of zelicapavir in paediatric patients with RSV infection.
The study will enrol approximately 150 participants aged 28 days to 36 months, including both hospitalised and non‑hospitalised patients with confirmed RSV infection. Participants will receive zelicapavir or placebo once daily for 7 days, with a 28‑day follow‑up period. Dosing will be weight‑ and age‑adjusted.
The primary endpoint of the study will assess the time to complete resolution of clinical signs of RSV infection, measured using the RESOLVE‑P clinical scoring scale, a tool developed to support evaluation in registrational trials. Secondary endpoints will include additional measures of clinical efficacy, antiviral activity, pharmacokinetics and safety.
The study will be conducted in Thailand, leveraging a network of clinical trial sites in regions where RSV seasonality supports timely study initiation.
Advancing paediatric research in RSV
RSV remains a major contributor to hospitalisation and morbidity among infants and young children globally. Despite recent advances in prevention strategies, effective therapeutic options remain limited.
Through this collaboration, Fondazione Penta continues to strengthen its role in international research networks, contributing to the development of evidence that may help bring new, effective treatments closer to children in need.
In the photo: Representatives from Penta, AMS‑PHPT Research Unit at Chiang Mai University and Enanta Pharmaceuticals at the study meeting in Chiang Mai, Thailand, June 2026