Vidac reports topline Phase 2b data for VDA-1102 in actinic keratosis

Vidac Pharma said topline results from a randomized Phase 2b study in Germany suggest its topical VDA-1102 may reduce marker-lesion severity in rapidly proliferating actinic keratosis. The small trial showed mixed clinical signals, no serious adverse events in the treatment group and will now feed into further analysis and possible Phase 3 planning.

Why it matters: - Vidac Pharma is trying to advance VDA-1102 as a topical treatment for actinic keratosis, a precancerous skin condition with ongoing clinical need. - The topline readout gives the company early clinical and imaging data that may shape the next development step, including how a future Phase 3 study could be designed.

What happened: - Vidac Pharma reported topline results from a randomized, double-blind, placebo-controlled Phase 2b study of topical VDA-1102 in rapidly proliferating actinic keratosis. - The study enrolled 39 participants in Germany. - Participants were randomized 2:1 to VDA-1102 or placebo for 12 weeks. - The study evaluated changes in a selected marker lesion using line-field confocal optical coherence tomography, or LC-OCT, along with clinical assessments and safety measures. - The primary endpoint was the marker-lesion modified High PRO score at Week 12.

The details: - The VDA-1102 group showed a shift toward lower modified PRO grades. - Grade III marker lesions in the VDA-1102 group fell from 76.9% at baseline to 37.5% at Week 12. - In the placebo group, Grade III marker lesions were 46.2% at baseline and 44.4% at Week 12. - Twelve of 18 measurable Grade 3 lesions in the VDA-1102 group were modified to lower grades. - Two VDA-1102 recipients had a modified PRO score of zero at Week 12, compared with none in the placebo group. - Vidac said the small sample size and missing Week 12 assessments limit statistical interpretation of the findings. - The reported distributions are descriptive and reflect different numbers of evaluable participants at baseline and Week 12. - No serious adverse events were reported in the VDA-1102 group. - Three VDA-1102 recipients had nonserious skin reactions considered possibly treatment related. - Four of 26 VDA-1102 recipients discontinued treatment because of adverse events or lack of tolerability. - One of 13 placebo recipients discontinued treatment for the same reasons. - Vidac said VDA-1102 remains investigational and has not been approved for marketing.

Between the lines: - The dataset looks encouraging on lesion grading, but the company’s own caveat on sample size means the readout is better viewed as directional than definitive. - The imaging work with LC-OCT suggests Vidac is trying to pair clinical response with objective lesion-level measurement, which could matter if the company seeks a clearer endpoint package for late-stage development. - CEO Max Herzberg said the findings warrant further evaluation and will help the company assess response patterns and inform potential next steps, especially a proposed Phase 3 synopsis.

What's next: - Vidac is reviewing the full clinical, imaging and safety dataset with its clinical and statistical advisers. - Any additional subgroup analysis will be a post hoc interpretation of the reported results. - The company will prepare a full clinical study report after complete analysis. - Vidac says further development could include a potential Phase 3 study. - VDA-1102 remains under clinical development for actinic keratosis and cutaneous T-cell lymphoma.

The bottom line: - Vidac got an early signal, not a final verdict, and the next analysis phase will determine whether VDA-1102 has enough support to move toward a larger trial.