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 Conditional Approval Application Planned if Clinical Efficacy is Confirmed

GemVax & KAEL Co., Ltd. (GemVax, 082270) announced on the 28th that it has completed patient recruitment for the domestic Phase 2 clinical trial of GV1001, a treatment for progressive supranuclear palsy (PSP).

This Phase 2 trial will evaluate the efficacy and safety of GV1001 in 78 PSP patients over 6 months. Participants are divided into three groups: a placebo group, and two treatment groups receiving either 0.56 mg or 1.12 mg of GV1001. The trial is being conducted at leading hospitals, including Boramae Hospital, Seoul National University Hospital, Samsung Medical Center, Bundang Seoul National University Hospital, and Kyung Hee University Hospital, with Professor Ji-young Lee of Seoul National University Hospital serving as the principal investigator.

This marks Korea’s first clinical trial for PSP. With the final patient enrolled, it is expected that all patients will complete dosing by the end of September.

If the Phase 2 trial demonstrates efficacy and safety, GemVax plans to apply for conditional product approval and proceed with commercialization. GV1001 was designated as a 'development-stage orphan drug' by the Ministry of Food and Drug Safety in February, expediting the review process for conditional approval. Upon approval, the drug would also be granted four years of market exclusivity.

PSP is an atypical Parkinsonian syndrome characterized by a progressive inability to move the eyes (supranuclear palsy), as well as gait disturbances, rigidity, tremors, and cognitive decline. While its symptoms resemble those of Parkinson’s disease, PSP progresses more rapidly and currently has no treatment. The condition is pathophysiologically linked to Alzheimer’s disease, with neuroinflammation and tau protein damage leading to neuronal cell death.

In preclinical trials using TauP301L0BiFC mice, GV1001 demonstrated its ability to inhibit the hyperphosphorylation and aggregation of tau proteins, improving both motor and cognitive function. These promising results were highlighted at international conferences. At the International Congress of Parkinson's Disease and Movement Disorders (MDS) in Denmark, the trial results were presented as a late-breaking abstract. At Neuro2023, Dr. Günter U. Höglinger, a leading expert from Ludwig-Maximilians University (LMU), Munich, also recognized GV1001 as a new multi-mechanism drug candidate for PSP.

In addition to the ongoing trial, GemVax is conducting a 12-month extension study for patients who wish to continue. In this single-group trial, all participants will receive 1.12 mg of GV1001 for an additional 12 months, allowing GemVax to gather further data on the long-term effects of the drug.

Global clinical trials for PSP are also progressing. In February, the U.S. FDA approved GemVax’s Phase 2 clinical trial plan for PSP, and the company is preparing to launch similar trials in Europe and the UK.

A GemVax official stated, “PSP presents a high unmet medical need, with no current treatment available to slow its progression or cure the disease. As we approach the completion of our Phase 2 trial, we are nearing the commercialization of the world’s first PSP treatment.”

GV1001, a telomerase-based peptide, is a multi-mechanism drug with anti-inflammatory, antioxidant, and anti-aging properties. It has been recognized as a disease-modifying treatment for neurodegenerative diseases, not only alleviating symptoms but also improving the immune environment in the brain and protecting nerve cells. In October of last year and January of this year, additional data on GV1001's mechanism for treating Alzheimer's disease and its anti-aging effects were disclosed, further contributing to the growing body of evidence on its mechanism of action.

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