GemVax Completes Dosing for Phase 2 Extension Trial of Progressive Supranuclear Palsy Treatment

On September 23, GemVax & KAEL announced that it has completed all dosing for the Phase 2 extension clinical trial of 'GV1001', its investigational treatment for progressive supranuclear palsy (PSP).

GemVax began the Phase 2 preliminary clinical trial for PSP in June 2023 with the enrollment of its first patient. After receiving approval from the Ministry of Food and Drug Safety, the company has been conducting a total of 18 months of PSP clinical trials, including an extension trial for patients who completed the preliminary trial and agreed to participate in the extension study.

According to GemVax, 67 patients participated in the extension clinical trial. The company recently completed the process, including dosing and the final observation. More than 85% of the participants from the preliminary clinical trial took part in the extension study. The results of the Phase 2 PSP clinical trial will be received from the contract research organization (CRO) after further data analysis.

GemVax confirmed the potential of GV1001 as a PSP treatment through the preliminary clinical trial. The topline results of the preliminary trial demonstrated that the group receiving 0.56mg of GV1001 showed good tolerability and a tendency to slow disease progression. Recently, an interim analysis combining six-month data from both the preliminary and extension trials showed statistically significant efficacy compared to an external control group.

As GemVax sequentially receives results from the Phase 2 clinical trial, the company is concretizing the design for a global Phase 3 clinical trial through ongoing data analysis and strategic communication with key opinion leaders. Based on systematic preclinical preparation, GemVax expects to be able to promptly proceed to the next phase of clinical trials.

The Fast Track and Orphan Drug Designations from the US Food and Drug Administration (FDA), as well as the Orphan Drug Designation from the European Medicines Agency (EMA), are expected to serve as major drivers for the smooth progress of GV1001's global Phase 3 trial.

A GemVax representative stated, "We are making company-wide efforts to launch the global Phase 3 clinical trial for PSP next year," and added, "We will do our utmost to succeed in developing the world's first treatment for PSP."

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