Benzinga | Nov 18, 2021 07:32AM EST

Verrica Pharma Reports FDA Accepted Its Investigational New Drug Application For LTX-315 For Treatment Of Basal Cell Carcinoma

Company expects to initiate Phase 2 trial in basal cell carcinoma in 1Q 2022

Non-melanoma skin cancers are the most common form of cancer in the U.S., with over 5 million diagnoses each year

WEST CHESTER, Pa., Nov. 18, 2021 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. ("Verrica") (NASDAQ:VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that the U.S. Food and Drug Administration ("FDA") has accepted the Company's Investigational New Drug Application ("IND") for LTX-315, a potential first-in-class oncolytic peptide, for the treatment of basal cell carcinoma. The Company expects to initiate its Phase 2 trial of LTX-315 in basal cell carcinoma in the first quarter of 2022.

"We are excited to bring this novel immunotherapy to the clinic as a potential new non-surgical treatment for skin cancer," said Ted White, Verrica's President and Chief Executive Officer. "LTX-315, a non-surgical immunotherapy that targets cancerous skin cells, is a remarkably innovative approach to skin cancer and represents a new treatment paradigm beyond invasive surgery. With nearly 5 million diagnoses of non-melanoma skin cancer in the U.S. each year, of which nearly 80 percent are basal cell carcinomas, there is a significant need for new treatment options."

"LTX-315's unique mechanism of action is clearly an innovative approach to potentially provide significant improvement over invasive surgery. LTX-315 has the potential to revolutionize one of the most common disease states in dermatology -- non-melanoma skin cancer," said Dr. Gary Goldenberg, Verrica's Chief Medical Officer.

"It will be an honor to serve as the lead primary investigator in the Verrica LTX-315 trial for the treatment of basal cell carcinoma. Most of the current treatment options for non-melanoma skin cancers can cause pain, scarring and infection. LTX-315 has the potential for treating these malignancies in a non-surgical manner through intratumoral injection," said Dr. Neal Bhatia, Director of Clinical Dermatology at Therapeutics Clinical Research in San Diego.