SHENZHEN, China – October 2026 – Pamplona Therapeutics (Shenzhen) Co., Ltd. ("Pamplona Therapeutics"), a clinical-stage biotechnology company developing targeted protein degradation therapies, today announced a significant clinical milestone: all healthy adult subjects have completed dosing and safety follow-up in the Phase I clinical trial of PAM-194 ointment, the company's proprietary first-in-class topical targeted protein degrader (TPD).

About the Phase I Clinical Trial

The Phase I study is a randomized, double-blind, placebo-controlled, single-center, dose-escalation trial designed to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of PAM-194 ointment following single and multiple topical ascending doses in healthy adult volunteers. The trial was conducted at Huashan Hospital Affiliated to Fudan University, led by Professor Jing Zhang, Director of the Phase I Clinical Research Center.

Clinical Progress and Initial Observations

On September 15, the final healthy subject successfully completed the scheduled study protocol and safety follow-up (Last Patient Out). Based on blinded safety monitoring and preliminary pharmacokinetic evaluations to date:

Favorable Safety and Tolerability Profile: PAM-194 ointment was well-tolerated across all evaluated dose cohorts. No dose-limiting toxicities (DLTs) or serious adverse events (SAEs) have been reported throughout the study.

Minimal Systemic Exposure: Preliminary PK assessments demonstrated extremely low systemic drug exposure following topical application, supporting the targeted product profile of achieving high local tissue concentration while minimizing potential systemic side effects.

Next Steps

The study team is actively conducting data cleaning and blinded data review according to standard Good Clinical Practice (GCP) workflows. Database lock (DBL) and the release of the Clinical Study Report (CSR) are anticipated by the end of 2026. The comprehensive dataset will provide crucial clinical rationale and dose-selection guidance for upcoming clinical trials in target patient populations.

"Completing healthy volunteer dosing and follow-up in our Phase I trial marks an essential milestone in the clinical translation of our targeted protein degradation platform," said Jinsong Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of Pamplona Therapeutics. "We extend our sincere gratitude to Professor Jing Zhang's clinical team at Huashan Hospital and our development colleagues for their rigorous execution. We remain committed to advancing PAM-194 through clinical development to deliver novel, targeted therapeutic solutions for patients in need."

About PAM-194

PAM-194 is a proprietary, first-in-class targeted protein degrader formulated as a topical ointment. Leveraging Pamplona Therapeutics' protein degradation discovery platform, PAM-194 is designed to overcome limitations of traditional small molecule inhibitors by inducing catalytic target degradation locally, offering a potential therapeutic option characterized by enhanced local potency and minimal systemic toxicity.