In 2013, the company completed Phase I, a randomized, double-blind, placebo-controlled, dose-escalating study in 22 healthy volunteers. The clinical trial tested the safety, tolerability, and pharmacokinetic profile of the ZEP-3 topical dosage form.
The Phase, I safety results and data review, indicated that ZEP-3 cream was well tolerated when administered topically four times daily during five consecutive days over a treatment area that appears to be safe and showed a clear skin pharmacokinetic profile.
The company has completed a Phase II clinical study in Herpes Labialis. The study was conducted as a multi-center study, randomized, double-blind, active-controlled in 210 recurrent Herpes Labialis patients. The critical study objective was to evaluate and compare the safety and therapeutic efficacy of the topical administration of ZEP-3 in comparison to Acyclovir cream following five consecutive administration days for the treatment of Herpes Labialis.
After initial analysis of the patients according to the responder definition (“Cure within six treatment days”), ZEP-3 has exhibited in the Per Protocol population a clear advantage over Zovirax (Acyclovir), the industry standard for treatment of Herpes Labialis.
The study’s primary endpoints were achieved in all critical criteria: time to healing, time to relief, and decrease in pain intensity.
SIS is submitting a pre-IND filing through a meeting with the FDA. Following such regulatory approval, plans to initiate a US-based Phase III study in Herpes Labialis.
In addition, the company is conducting a Phase II clinical study for Atopic Dermatitis (a common, underserved skin condition affecting mainly children) in Israel in 9 clinical sites at the leading dermatology departments at hospitals and community clinics in Israel.
SIS has conducted a large variety of pre-clinical studies according to the requirements of the health regulatory authorities, all to support the pharmaceutical development of ZEP-3 and ZEP-4 as topical cream products and establish their safety efficacy.
The company’s peptides were assessed for safety and efficacy and safety in several pre-clinical in-vitro, ex-vivo, and in-vivo studies. ZEP-3 and ZEP-4 demonstrated anti-inflammatory, anti-viral activity, and analgesic agents in the pre-clinical studies, inhibiting the replication and spreading of Herpes Simplex Virus Type 1 (HSV1) and Type 2 (HSV-2) in a dose-dependent fashion without any detectable adverse side effects.
In addition, Efficacy studies have shown that ZEP-3 is equally effective both on HSV-1 and HSV-2 for acyclovir-resistant viruses where a growing population does not respond to the existing therapy because of acyclovir resistance.
Moreover, ZEP-3 reduced the clinical symptoms of the Atopic Dermatitis model in mice, demonstrated dose-dependent inhibition of IL-6 and TNF- a production in LPS treated Human Keratinocytes, and ZEP-3 significantly reduced the presence of Eosinophils, Neutrophils, and G-CSF in the lung fluids by Intratracheal and by inhalation and led to a significant reduction of MIP-1α and IL-10.
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