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).
Phase II open-label exploratory study, n=42. Non-head-to-head comparison. Comparators from published literature.
ACS Biomed is an Italian biopharmaceutical company developing differentiated therapies and medical technologies for high unmet medical needs through clinical development, strategic partnerships and international commercialization.
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.
Increasing prevalence of nucleoside-analog resistance in HSV-2 — observed even in immunocompetent patients.
Piret & Boivin, Antiviral Research, 2011Frequent 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 AIDSZovirax® 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"Significant unmet needs"; "lack of preventive and curative therapies"; emerging resistance.
DelveInsight Market Report, 2025; Collins-Ogle & Herold, 2026
Oil-in-water nanoemulsion with 5 synergistic botanical actives. 97% efficacy in 96h. CPNP + UK.GOV registered.
Cold sores pocket treatment. 3ml compact format. 70% proven efficacy. Visible results in 24h.
Phase IIb head-to-head vs acyclovir with PPD (Thermo Fisher Scientific)
Fully budgeted Phase IIb/III program: 80 patients (ongoing) + 420 patients (planned Phase III)
Randomized, double-blind, active-controlled multicenter study comparing ErpeCream® efficacy vs acyclovir 5% in adult patients with recurrent genital HSV-2.
ACS Biomed actively seeks strategic partners for licensing, co-development, and regional commercialization across its pharmaceutical and medtech portfolio.
International business development activities continue as the company strengthens its global commercial and pharmaceutical network.
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Observational clinical experience collected by an independent physician contributes additional real-world insights into the use of ErpeCream® in patients with recurrent HSV infections.
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International multicentre clinical trial supports the pharmaceutical development of ErpeCream® and future regulatory strategy.
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