Vidac Pharma Holdings recently announced the commencement of a Phase 2b trial for its candidate therapy (VDA-1102) to treat actinic keratosis (AK), and has engaged with a research team from a leading clinical dermatology clinical research institute (CentroDerm GmbH).

According to the manufacturer, the candidate therapy, VDA-1102, is a one of a family of proprietary small molecules that modulate HK2, preventing it from blocking the VDAC channel, a signaling relay in mitochondria influencing cellular metabolism. Preclinical and early clinical studies suggest these are capable of reversing the abnormal metabolism of cancer cells, halting their hyperglycolysis (Warburg effect). 

“Non-melanoma skin cancers are the most-diagnosed cancers worldwide, and AK (the first step on the AK-squamous cell carcinoma [SCC] spectrum) is one of the most common among them," said Prof. Thomas Dirschka, and the founder of CentroDerm, in a news release. "Treating AK can be tricky, because only 20% of the lesions it causes might become cancerous, yet it is essential to spot and treat the ones that do,” said Prof. Dirschka, and the founder of CentroDerm, in a news release. “Currently available topical treatments are either not very effective, or cause unpleasant side effects that make them unattractive to patients and physicians. Vidac Pharma is now the first to perform a clinical trial into specifically this issue, with VDA-1102, which might offer the potential to significantly improve treatment.”

The second Phase 2b study will focus on advanced AK only and is designed to refine inclusion criteria and endpoints after the earlier Phase 2b found higher sensitivity in advanced AK to VDA-1102 than less severe (non-cancerous) forms of the disease. Finalized protocols will be submitted to health authorities in Germany, with endpoints will include clearance of advanced AK lesions, and the evolution of lesions after an observation period.

“This study has been designed with the benefit of our positive Phase 2a and first Phase 2b trials, which has allowed us to better define the scope of the study,” said Prof. Dr. Max Herzberg, Chairman of the Board and Founder of Vidac Pharma. “We believe the trial will allow us to de-risk pivotal Phase 3 testing and are looking forward to initiating it once we have sufficient funding.”