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

18 Months of Efficacy and Safety Data Secured
in Korea's First Clinical Trial

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 lead-in clinical trial for PSP in June 2023 with the enrollment of the first patient. After receiving approval from the Ministry of Food and Drug Safety, the company proceeded with an extension clinical trial for patients who completed the lead-in trial and agreed to participate in the extension study. In total, GemVax has conducted an 18-month clinical trial program for PSP, including both the lead-in and extension studies.

According to GemVax, 67 patients participated in the extension clinical trial, and the process, including the final dosing and last observation, has recently been completed. More than 85% of the subjects from the lead-in clinical trial took part in the extension study. The results of the phase 2 clinical trial for PSP will be received from the contract research organization (CRO) after data analysis is completed.

GemVax has already confirmed the potential of GV1001 as a PSP treatment through the lead-in trial. The topline results of the lead-in study demonstrated that the 0.56 mg GV1001 group showed good tolerability and a trend toward slowing disease progression. Recently, in an interim analysis combining six months of data from both the lead-in and extension studies, the company observed statistically significant efficacy compared to an external control group.

As it sequentially receives the results from the phase 2 clinical trial, GemVax is further refining the design of its global phase 3 clinical trial through ongoing data analysis and strategic communication with key opinion leaders.

The company believes that, with systematic advance preparations, it will be able to swiftly move on to the next stage of clinical development.

In addition, the Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration (FDA), as well as the Orphan Drug designation from the European Medicines Agency (EMA), are expected to provide significant momentum for the smooth progress of the global phase 3 trial of GV1001.

A GemVax representative stated, "We are grateful to the patients and medical staff who participated in this long-term study and persevered until the end. The company is making every effort to initiate the global phase 3 clinical trial for PSP next year. 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.