InscoBi Subsidiary APUS to Initiate FDA Phase 3 Clinical Trial for Multiple Sclerosis Treatment

Apimes US (hereinafter APUS), a subsidiary of InscoBi, a KOSPI-listed company, announced on the 20th that it plans to initiate Phase 3 clinical trials with the U.S. FDA, aiming to enter the global Multiple Sclerosis (MS) treatment market.

APUS plans to commence the FDA Phase 3 clinical trials immediately upon the inflow of funds from its IPO (Initial Public Offering) scheduled for February 2025. Prior to this, APUS has already obtained listing approval from the New York Stock Exchange (NYSE) and the U.S. Securities and Exchange Commission (SEC) targeting the FDA Phase 3 trials. The ongoing roadshow for the new share issuance is also nearing a successful conclusion, and all funds raised through the IPO will be fully invested in the FDA Phase 3 clinical trials.

The current Multiple Sclerosis treatment market is valued at over $20 billion (approximately 30 trillion KRW) worldwide, with the U.S. accounting for more than 70% of this market. It is a high-cost market where the annual treatment cost per patient exceeds 100 million KRW. APUS is advancing this clinical trial as an MS treatment that can receive better pricing based on FDA recommendations.

APUS’s core therapeutic agent, Apitox, has previously successfully completed FDA Phase 3 clinical trials for the indication of Osteoarthritis. Accordingly, Phase 2 clinical trials were waived based on existing FDA osteoarthritis clinical data, and APUS has currently received FDA IND (Investigational New Drug) approval for Phase 3 clinical trials for the MS indication.

APUS has completed consultations with a Contract Research Organization (CRO) and expects to conduct approximately two years of clinical trials after starting Phase 3, aiming to produce positive clinical results by early 2027.

A company representative stated, “After successfully completing the FDA Phase 3 clinical trials for this Multiple Sclerosis treatment, we plan to expand indications to various autoimmune diseases such as rheumatoid arthritis, lupus, and psoriasis. Under the U.S. Public Health Service Act (PHS Act) 351(a), biologics are granted exclusive rights for 12 years after FDA approval, and additional exclusivity periods are granted upon approval of additional indications. Based on this, APUS will secure a long-term exclusive position in the global market.”

This content was produced with the assistance of AI translation services.