JERUSALEM--(BUSINESS WIRE)--Vidac Pharma, a clinical stage oncology and dermatology focused pharmaceutical company, today announced initiation of a Phase 2b clinical trial of VDA-1102 ointment to treat subjects with actinic keratosis (AK), an early stage of cutaneous squamous cell carcinoma (cSCC), which is a common form of non-melanoma skin cancer. VDA-1102 is a selective allosteric modulator that triggers apoptosis in cancer cells by detaching hexokinase 2 (HK2) from the mitochondria. VDA-1102 is being developed as a first-in-class non-irritating topical treatment for AK, addressing a major unmet medical need because currently approved AK therapies are associated with a significant degree of local skin reactions, which can be very unsightly and burdensome to patients and lead to poor adherence to therapy.
The Phase 2b trial is a multi-center, open-label, dose-ranging study evaluating the efficacy, safety, and tolerability of daily application of topical 10% or 20% VDA-1102 ointment for 12 weeks in subjects with actinic keratosis. Subjects will be followed for one month after conclusion of treatment; the primary endpoint is percent of subjects that achieve complete clearance. The study is expected to enroll approximately 150 subjects in the US, in 2 cohorts.
“In a previous clinical proof-of-concept study (Phase 2a) VDA-1102 has demonstrated efficacy and tolerability in subjects suffering from AK,” said Chaim Brickman, MD, Vidac’s Chief Medical Officer. “We expect the current Phase 2b study to confirm these findings and establish the drug’s potential to change the landscape of AK treatments for patients suffering from this condition.”
“Vidac is committed to harness its metabolic immuno-oncology platform technology to create innovative targeted therapies for people suffering from a variety of oncological malignancies, including a variety of skin cancers,” said Dr. Oren M. Becker, Vidac’s president and CEO.
About Vidac Pharma
Vidac is a privately-held clinical oncology company developing first-in-class drugs using its breakthrough metabolic immuno-oncology platform technology. Vidac uses its proprietary HEXAGON™ bioinformatics tool to identify patients with cancers with high HK2 levels, across multiple tumor types. Vidac’s lead drug, VDA-1102 ointment is in Phase 2b for treatment of actinic keratosis (early skin SCC), and is being developed in a parenteral form for the treatment of solid tumors and hematological malignancies.
For information visit www.vidacpharma.com.