On Friday, Samsung Pharm said it has submitted an application to the Ministry of Food and Drug Safety (MFDS) seeking approval to modify the investigational new drug (IND) plan for the phase 3 clinical trial of its Alzheimer's treatment, GV1001.

The amended protocol is designed to test the superiority of GV1001 1.12 mg for 24 weeks (six months) in 750 patients with moderate to severe Alzheimer's disease through the Severe Impairment Battery (SIB) and overall clinical assessment (CIBIC-plus, Clinician's Interview-based Impression of Change-plus).

Simplifying the dosing regimen will reduce the number of patients in the study. Initially, there were two GV1001 dose groups, 0.56 mg, and 1.12 mg, but the trial will be conducted with only the 1.12 mg group by excluding the 0.56 mg group, curtailing the number of patients from 936 to 750.

Samsung Pharm acquired the domestic rights to GV1001 from GemVax & Kael in May last year.

"The change request is a decision to accept the evaluation and recommendations of experts on the phase 2 results, which showed a significant effect in the high dose group of 1.12 mg of GV1001," a Samsung Pharm official said. "If approved by the MFDS, the development speed to commercialization will be further accelerated by shortening the clinical trial period and reducing costs."

According to Samsung Pharm, GV1001 1.12 mg demonstrated improvement in the primary efficacy endpoint of severe disability score in phase 2, and safety analyses showed no adverse events or adverse drug reactions.

The development of GV1001 for Alzheimer's disease is being led by Samsung Pharm in Korea and GemVax & Kael globally. The latter is conducting a global phase 2 trial in the U.S. and seven European countries.

If the IND change is approved, Samsung Pharm will commercialize GV1001 to put a differentiated treatment for Alzheimer's disease on the market, the official said.