Comprehensive dossier underscores rigorous scientific, clinical, and CMC preparation, with key support from CRO partners
Vidac Pharma Holdings Plc. (Hamburg and Stuttgart: T9G; ISIN: GB00BM9XQ619; WKN: A3DTUQ), a clinical-stage oncology biopharmaceutical company pioneering a novel class of cancer treatments, today announced the submission of a Clinical Trial Application (CTA) to the European Medicines Agency (EMA) for a new interventional study targeting advanced actinic keratosis (AK) lesions. The submission reflects a thorough cross-functional effort by Vidac Pharma’s R&D, clinical operations, regulatory, and quality teams, working closely with Forschungsdock CRO GmbH to deliver a complete and scientifically robust dossier.
The CTA package includes the full study protocol, Investigator’s Brochure, patient-safety monitoring plan, statistical analysis plan, and comprehensive Chemistry, Manufacturing and Controls (CMC) documentation for the investigational product. The filing also encompasses nonclinical and prior clinical data, data-integrity and GCP frameworks, and GDPR-compliant processes to protect participant privacy. The study will take place at Centroderm in Wuppertal, Germany, a leading dermatology clinical site, under the direction of Prof. Thomas Dirschka.
Dr. Max Herzberg, Chief Executive Officer of Vidac Pharma, commented:
“This submission represents months of meticulous cross-functional work, with outstanding support from our CRO partners, to ensure EMA reviewers receive clear and comprehensive evidence supporting the scientific rationale, study design, and patient protections. Our Phase 2 research trial is designed to refine the endpoints we aim to carry into a pivotal Phase 3 program. We are proud of the collaborative effort behind this application, which reflects our commitment to advancing a well-controlled study addressing the unmet needs of patients with advanced AK lesions, while upholding the highest standards of quality and ethics.”
About the Study Design
The planned Phase 2 study will evaluate the safety, tolerability, and efficacy signals of Vidac Pharma’s investigational therapy in participants with advanced AK lesions. The protocol features well-defined inclusion criteria, clinically meaningful endpoints, centralized and site-level quality controls, blinded assessments where applicable, and predefined interim analyses to ensure robust, decision-enabling data.
Vidac Pharma will provide updates following EMA’s validation phase and subsequent regulatory interactions in line with standard procedures.
For more information please contact:
Vidac Pharma Holdings Plc.
Dr Max Herzberg
20-22 Wenlock Road
London N1 7GU
United Kingdom
http://www.vidacpharma.com/
investors@vidacpharma.com
+972-54-4257381
About Vidac Pharma
Vidac Pharma Holdings Plc. is a clinical-stage biopharmaceutical company dedicated to discovering and developing first-in-class medicines to help people suffering from a range of oncologic and onco-dermatologic diseases. Vidac Pharma develops first-in-class anti-cancer drugs by modifying the hyper-glycolytic tumor microenvironment, targeting the overexpression and mis-anchoring of the Hexokinase 2 metabolic checkpoint (HK2) in cancer cells, to renormalize the tumor microenvironment and selectively induce programmed cell death, without affecting surrounding normal tissue. VDA-1102, Vidac Pharma’s first drug candidate, has demonstrated effectiveness against advanced Actinic Keratosis (AK), and in Cutaneous T-cell Lymphoma (CTCL) showed positive effects in Phase 2 human trials.
Important Information
The information in this press release does not constitute a public offer to sell or a solicitation to submit an offer to buy or subscribe to shares of Vidac Pharma Holdings Plc., but is for informational purposes only. The contents of this announcement include statements that are, or may be deemed to be, ‘forward-looking statements.’ These forward-looking statements can be identified by the use of forward-looking terminology, including the words ‘believes,’ ‘estimates,’ ‘anticipates,’ ‘expects,’ ‘intends,’ ‘may,’ ‘will,’ ‘plans,’ ‘continue,’ ‘ongoing,’ ‘potential,’ ‘predict,’ ‘project,’ ‘target,’ ‘seek,’ or ‘should,’ and include statements the Company makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties, and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The Company’s actual results may differ materially from those predicted by the forward-looking statements. The Company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.
