Following the successful launch of its independently developed epilepsy treatment, ‘Cenobamate’ (marketed in the U.S. as Xcopri), SK Biopharm is accelerating the development of its next-generation product.

The Ministry of Food and Drug Safety recently approved the Phase 3 clinical trial for SK Biopharm’s ‘Carisbamate’ (development code YKP509) on the 10th. As SK Biopharm’s U.S. subsidiary, SK Life Science, is leading the global clinical trials for Carisbamate, these trials are classified as international.

Carisbamate is a candidate drug being developed by SK Biopharm for the treatment of the rare Lennox-Gastaut syndrome (LGS). Initially licensed to Johnson & Johnson (J&J) by SK Corp. in 1999, the rights were later returned, and SK Biopharm has continued its development.

In the Phase 3 trials, SK Biopharm will evaluate the efficacy and safety of Carisbamate suspension as an adjunctive therapy for seizures associated with Lennox-Gastaut syndrome in both pediatric and adult patients. The trials will be conducted at various institutions including Chilgok Kyungpook National University Hospital, Samsung Medical Center, and Seoul National University Hospital.

Additionally, in January, SK Biopharm submitted an IND (Investigational New Drug) application for Phase 3 trials to the U.S. FDA and is currently recruiting patients across eight hospitals in the U.S. and Colombia. The target enrollment is 252 patients, with the clinical trial expected to be completed by January 2025.

Regarding the Phase 3 approval by the Ministry of Food and Drug Safety, SK Biopharm expressed its ambition to make Carisbamate the next flagship product following Cenobamate. An SK Biopharm representative stated, "While Cenobamate has been our main product, we expect Carisbamate to be our next major product, or 'next step.'"

In related news, according to a disclosure on the 10th, SK Biopharm reported consolidated sales of 88.8 billion KRW, an operating loss of 9.2 billion KRW, and a net loss of 15 billion KRW for the third quarter. Although sales increased by 270.91% year-on-year and 66.25% quarter-on-quarter, the company continued to incur losses.

SK Biopharm attributed its sales growth to the ongoing expansion in the U.S. and new market entries in Latin America and Europe. The company highlighted that the operating loss was significantly reduced by 40.7 billion KRW year-on-year to 9.2 billion KRW due to substantial increases in product and service sales.

Regarding Cenobamate, SK Biopharm noted that it has maintained strong growth since its U.S. launch and expects to exceed its global sales target of 185 billion KRW for the year, driven by accelerated expansion in Europe. The cumulative sales of Cenobamate in the U.S. for the third quarter totaled 119.4 billion KRW.

To boost Cenobamate's brand recognition, SK Biopharm plans to participate in the American Epilepsy Society (AES) conference in the fourth quarter and engage in various academic meetings and events to enhance promotion and marketing efforts aimed at epilepsy specialists.