ACS Biomed Advances Phase IIb Clinical Development Programme with PPD

ACS Produzioni Biomed S.r.l. (“ACS Biomed”), an Italian biotechnology company developing innovative therapies for Herpes Simplex Virus (HSV) infections, continues to advance the pharmaceutical development of ErpeCream® through its ongoing Phase IIb clinical programme, managed in collaboration with PPD, part of Thermo Fisher Scientific, one of the world's leading contract research organisations.

The study represents a significant milestone in the company's long-term strategy of transforming its proprietary topical technology into a pharmaceutical product supported by robust clinical evidence and designed for future regulatory submissions in major international markets.

Building on previous scientific research and encouraging early clinical observations, the Phase IIb programme is designed to evaluate the efficacy and safety of ErpeCream® in patients with recurrent genital herpes while generating the clinical dataset required to support future development.

An International Clinical Programme

The Phase IIb study has been designed as a randomised, double-blind, active-controlled multicentre clinical trial, comparing ErpeCream® with topical acyclovir in adult patients affected by recurrent HSV-2 infection.

The programme is being conducted across 25 investigational sites in seven European countries, following internationally recognised clinical research standards and Good Clinical Practice (GCP).

By partnering with PPD, ACS Biomed benefits from the operational expertise and scientific capabilities of a globally recognised CRO with extensive experience in managing multinational clinical studies.

The objective is to generate high-quality clinical evidence supporting the future pharmaceutical development of the company's proprietary formulation.

Building Long-Term Pharmaceutical Value

The Phase IIb programme represents an important component of ACS Biomed's broader development strategy, which combines commercial activities with continued scientific innovation.

The clinical data generated during the study will contribute to future regulatory planning, scientific publications and discussions with pharmaceutical companies interested in licensing or co-development opportunities.

Together with independent laboratory evaluations, regulatory progress and international commercial expansion, the clinical programme strengthens the company's long-term objective of building a differentiated pharmaceutical platform focused on HSV infections.

Looking Ahead

Following completion of the Phase IIb programme, ACS Biomed intends to continue advancing the clinical development of ErpeCream® through subsequent regulatory and clinical milestones, with the long-term objective of supporting future submissions to international regulatory authorities.

The company believes that combining scientific validation, clinical development and international commercial partnerships provides a strong foundation for creating long-term value while addressing a significant unmet medical need in recurrent HSV management.