Lytix Biopharma, in collaboration with Verrica Pharmaceuticals, has announced positive preliminary topline results from Part 2 of its Phase II clinical study of LTX-315 (VP-315) for the treatment of basal cell carcinoma (BCC). The data, presented at the Fall Clinical Dermatology Conference, highlights the potential of LTX-315 as a non-surgical treatment option for this prevalent skin cancer.
Promising Efficacy and Safety Data
The Phase II study evaluated the safety, tolerability, and antitumor efficacy of LTX-315 in patients with BCC. Results showed that approximately 51% of treated tumors achieved complete elimination of tumor cells. Furthermore, an 86% overall reduction in tumor size was observed. Importantly, no treatment-related serious adverse events were reported during the study.
Dr. Øystein Rekdal, CEO of Lytix Biopharma, expressed enthusiasm about the results, stating, "We are excited about the strong clinical results demonstrating the potent anticancer effects of LTX-315 in basal cell carcinoma... With such promising efficacy and safety data, we see significant commercial potential in addressing one of the largest and fastest-growing cancer markets globally."
Addressing a Significant Unmet Need
Basal cell carcinoma is the most common type of skin cancer, with an estimated 3.6 million new cases diagnosed annually in the US. Approximately 80% of BCCs are located on the face and head, highlighting the need for effective and non-invasive treatment options. The current global market size for BCC is projected to reach USD 11.5 billion in 2028.
LTX-315 offers a potential non-surgical alternative for the three to four million cases of BCC diagnosed in the U.S. each year. Physicians also highlighted the potential of LTX-315 to be used as a first-line therapy.
Next Steps
Verrica Pharmaceuticals expects to finalize the Phase II study in the first half of 2025 and plans to request an End-of-phase II meeting with the Food and Drug Administration (FDA) to determine the next steps for the development of LTX-315 for the treatment of BCC.
Under the license agreement, Lytix Biopharma may receive up to USD 110 million in milestone payments and tiered royalties on worldwide annual net sales.
