Phase IIb Ongoing

A natural topical with superior efficacy to acyclovir — commercially available, Phase IIb ongoing

ErpeCream® demonstrates 97% lesion remission at 96 hours with a favorable safety profile (zero adverse events). Already registered in EU and UK. Phase IIb head-to-head vs acyclovir in progress with PPD (Thermo Fisher Scientific).

  • 97% lesion remission at 96 hours vs 20% for topical acyclovir (Zovirax®)
  • CPNP + UK.GOV registered — available for global distribution now
  • Phase IIb: 80 patients, head-to-head vs acyclovir, CRO: PPD (Thermo Fisher Scientific)
*

Phase II open-label exploratory study, n=42. Non-head-to-head comparison. Comparators from published literature.

The Problem

Why acyclovir is no longer sufficient

Acyclovir has been the standard of care for genital HSV since the 1980s. Yet resistance is rising, recurrence rates remain unacceptably high, and available topical formulations show only modest efficacy.

Growing Resistance

Increasing prevalence of nucleoside-analog resistance in HSV-2 — observed even in immunocompetent patients.

Piret & Boivin, Antiviral Research, 2011

Frequent Recurrences

Frequent recurrences (6-10/year) with QoL impact. Recurrences ≥5/year predict worse psychological outcomes (p<0.01); depression in 29% of patients.

Gupta et al., 2025, Int J STD AIDS

Low Topical Efficacy

Zovirax® topical (acyclovir 5%): cited as having 'no evidence of clinical benefit' for recurrences and 'no real activity over placebo' in clinical reviews.

Skyscape Clinical Consult; FDA Prescribing Info

Unmet Clinical Need

"Significant unmet needs"; "lack of preventive and curative therapies"; emerging resistance.

DelveInsight Market Report, 2025; Collins-Ogle & Herold, 2026
Consumer Products

Two registered products. Available today.

Genital HSV-2
ErpeCream product packaging

ErpeCream®

Oil-in-water nanoemulsion with 5 synergistic botanical actives. 97% efficacy in 96h. CPNP + UK.GOV registered.

Formats: 5ml (single episode) · 15ml (up to 3 episodes)
  • No systemic absorption · Zero adverse events in Phase II
  • Distribution active: Europe, Gulf, Latam
Cold Sores HSV-1
ErpeLips product packaging

ErpeLips™

Cold sores pocket treatment. 3ml compact format. 70% proven efficacy. Visible results in 24h.

  • 100% natural patented formula · Neutral color (invisible application)
  • Zero side effects · CPNP registered
  • Targeting 3.7B HSV-1 patients globally (WHO)
Phase IIb Underway

Clinical validation in progress

Phase IIb head-to-head vs acyclovir with PPD (Thermo Fisher Scientific)

80
patients
(Phase IIb)
7
countries
25
Study Sites
PPD
CRO Partner
Thermo Fisher

Fully budgeted Phase IIb/III program: 80 patients (ongoing) + 420 patients (planned Phase III)

Study Design

Randomized, double-blind, active-controlled multicenter study comparing ErpeCream® efficacy vs acyclovir 5% in adult patients with recurrent genital HSV-2.

Primary Endpoint
Time to complete lesion healing
Timeline
7-8 months to primary readout
Study BC147404-01
Phase IIb started January 2026

Study Sites

4United Kingdom5Spain5Germany3Estonia3Romania3Bulgaria2MoldovaMain sites (3-5)Supporting sites (2)
Bulgaria3
Estonia3
Germany5
Moldova2
Romania3
Spain5
United Kingdom4

Structured for Partnership

ACS Biomed actively seeks strategic partners for licensing, co-development, and regional commercialization across its pharmaceutical and medtech portfolio.

Headquartered in Udine, Italy
CRO Collaboration Model (PPD)
EMA / FDA Regulatory Alignment
EU & US Patent Portfolio
EU + US Target Markets