In 2013, the company completed a Phase I, 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 review of the Phase I safety data results indicated that ZEP-3 cream at either 0.1% or 1.0% strength was well tolerated when administered topically 4 times daily during 5 consecutive days over a treatment area appears to be safe and showed a favorable skin pharmacokinetic profile.
Recently, 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 key study objective was to evaluate and compare the safety and therapeutic efficacy of the topical administration of ZEP-3 ointment (1.0%) in comparison to Acyclovir cream (5%) following five consecutive administration days for the treatment of Herpes Labialis. After initial analysis of the patients according to the responder definition (“Cure within 6 treatment days”), ZEP-3 has exhibited in the Per Protocol population an advantage over Zovirax (Acylovir). The study’s primary endpoints were achieved in the all key criteria: time to healing, time to relief and decrease in pain intensity.
SIS is planning to schedule a pre-IND meeting with the FDA in Q1/2019, and following such regulatory approval, plans to initiate a US-based Phase II study in Herpes Labialis.
In addition, the Company plans to begin a Phase II clinical study for Atopic Dermatitis in Israel in Q2/2019.
SIS has conducted a large variety of pre-clinical studies in accordance with the requirements of the health regulatory authorities, all in order to support the pharmaceutical development of ZEP-3 and ZEP-4 as topical cream products and to establish their safety and efficacy. The company’s lead product (branded ZEP-3) was assessed for its safety and efficacy in several pre-clinical in-vitro, ex-vivo and in-vivo studies. In addition to its analgesic activity, ZEP-3 cream demonstrated anti-viral activity in the pre-clinical studies, inhibiting the replication and spreading of Herpes Simplex Virus Type 1 (HSV1) in a dose dependent fashion without any detectable adverse side effects.
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