Samsung Pharm has received approval from the Ministry of Food and Drug Safety (MFDS) to change the investigative new drug (IND) application for its phase 3 clinical trial of GV1001 for Alzheimer's disease.

The MFDS accepted Samsung Pharm's application to simplify GV1001's dosing regimen, approving a change in the protocol from two 0.56 mg and 1.12 mg arms to a single 1.12 mg arm. With the unification of the dose groups, the number of patients will fall from 936 to 750.

With this approval, Samsung Pharm will begin a phase 3 clinical trial to evaluate the safety and efficacy of GV1001.

The trial will enroll 750 patients with moderate to severe Alzheimer's disease to determine superiority over placebo using the Severe Impairment Battery (SIB) and Clinician's Interview-Based Impression of Change-plus (CIBIC-plus) after 24 weeks (six months) of treatment with 1.12 mg of GV1001, according to the company.

Unlike commercially available treatments for mild or early-stage Alzheimer's disease, GV1001 is being developed for patients with moderate to severe Alzheimer's disease, and there have been no adverse events or adverse drug reactions.

In particular, GV1001 1.12mg showed significant improvement in the primary efficacy endpoint of SIB in phase 2, slowing the progression of Alzheimer's disease.

"With this approval, we can start phase 3 for Alzheimer's disease in Korea," a Samsung Pharm official said. "As we have confirmed safety and efficacy in phase 2, we will do our best to introduce a differentiated new drug to the Alzheimer's disease treatment market through phase 3."

Samsung Pharm acquired the domestic clinical trial rights for GV1001 from GemVax & Kael in May last year. GemVax & Kael is conducting the global phase 2 trial of GV1001 for Alzheimer's disease in the U.S. and seven European countries.