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Gemvax & KAEL (Gemvax) announced on the 24th that it has received the topline results of the domestic phase 2a clinical trial of GV1001 for patients with progressive supranuclear palsy (PSP).
Clinical results showed excellent effectiveness in the GV1001 0.56mg administration group. In particular, it was confirmed to have high potential as a treatment in the progressive supranuclear palsy-Richardson syndrome (PSP-RS) type patient group. As in all previous clinical trials of GV1001, safety was confirmed once again.
In this phase 2a clinical trial of GV1001, placebo, 0.56mg of GV1001, and 1.12mg were administered to 78 PSP patients in Korea for 6 months.
The change in PSP rating scale score, calculated as the least square mean (LS mean) using the MMRM estimation method, which is the primary evaluation variable, worsened by 2.14 points in the GV1001 0.56mg treatment group over 6 months, while the placebo group worsened by 4.10 points. In the treatment group, disease progression was delayed by 48%. In addition, in a simple average analysis performed by post-ad hoc sensitivity analysis, the GV1001 0.56 mg treatment group worsened by 1.35 points, while the placebo group worsened by 4.36 points, delaying disease progression by 70% in the treatment group.
The company said, “The typical type of PSP commonly referred to clinically is the PSP-RS type, which accounts for the majority of all PSP patients,” and added, “Compared to other PSP types, the disease progresses faster and the average survival period is shorter.” He explained.
In this clinical trial, when the target patients were narrowed down to PSP-RS type, the least square mean value worsened by 1.88 points in the GV1001 0.56mg group, while it worsened by 4.45 points in the placebo group. In the treatment group, disease progression was delayed by 58%. In addition, in the simple mean value analysis performed by post-ad hoc sensitivity analysis, the GV1001 0.56mg treatment group worsened by 0.25 points, while the placebo group worsened by 5.19 points, delaying disease progression by 95% in the treatment group.
In the case of PSP-RS type patients in the medication group, there were many cases where symptoms were maintained or even improved during the clinical period. When looking at the response rate calculated as the ratio of patients whose scores improved or were maintained after 6 months of treatment compared to the PSP grading scale score measured just before the first administration, the rate in the PSP-RS patient group administered 0.56 mg of GV1001 reached 58.33%.
Regarding safety, the safety of GV1001 was once again confirmed, with no serious side effects related to the drug reported.
A Gemvax official said, “This phase 2a clinical trial was conducted to explore the optimal dose and did not show statistical significance, but it confirmed the potential of GV1001 as the world’s first treatment for PSP disease.”
Gemvax plans to accelerate phase 3 clinical development and business development for future commercialization by consulting with scientific advisory groups and PSP experts based on information obtained from clinical results.
Reporter Kim Yu-rim [email protected]
