Lytix Biopharma, in collaboration with Verrica Pharmaceuticals, has announced positive 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 anti-tumor efficacy of LTX-315 in patients with BCC. Results showed that approximately 51% of treated tumors experienced complete elimination of tumor cells. Furthermore, an 86% overall reduction in tumor size was observed. Importantly, the study reported no treatment-related serious adverse events, indicating a favorable safety profile.
Dr. Øystein Rekdal, CEO of Lytix Biopharma, stated, "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 United States. The global market for BCC treatment is projected to reach USD 11.5 billion by 2028. Current treatment options often involve surgical removal, which can be invasive and may not be suitable for all patients, especially those with tumors in sensitive areas like the face.
LTX-315 offers a potential non-surgical alternative, addressing a significant unmet need in the treatment of BCC. Verrica Pharmaceuticals estimates that LTX-315 could serve as a first-line therapy for the three to four million cases of BCC diagnosed in the U.S. each year.
Study Design and Next Steps
The Phase II study is designed to evaluate the safety, tolerability, and anti-tumor efficacy of LTX-315 in patients with BCC. Verrica expects to finalize the Phase II study in H1 2025 and plans to request an End-of-phase II meeting with the Food and Drug Administration (FDA) to determine next steps for the development of LTX-315 for the treatment of BCC in the first half of 2025.
Under the license agreement with Verrica Pharmaceuticals, Lytix may receive aggregate payments of up to USD 110 million upon achieving certain clinical, regulatory, and sales milestones and tiered royalties based on worldwide annual net sales ranging in the low double digits to the mid-teens.
