VGN-R09b / Shanghai Vitalgen BioPharma - LARVOL DELTA

A Trial to Evaluate Safety and Efficacy of a Product Named VGN-R09b in Severe AADC Deficiency (clinicaltrials.gov) - P2/3 | N=13 | Active, not recruiting | Sponsor: Shanghai Vitalgen BioPharma Co., Ltd. | Phase classification: P3 ➔ P2/3

Phase classification • Genetic Disorders

A Trial to Evaluate Safety and Efficacy of a Product Named VGN-R09b in Severe AADC Deficiency (clinicaltrials.gov) - P3 | N=13 | Active, not recruiting | Sponsor: Shanghai Vitalgen BioPharma Co., Ltd. | Not yet recruiting ➔ Active, not recruiting | Phase classification: P1 ➔ P3

Enrollment closed • Phase classification • Genetic Disorders

VGN-R09b-101: A Trial to Evaluate Safety and Efficacy of a Product Named VGN-R09b in Patients With Parkinson's Disease (clinicaltrials.gov) - P1/2 | N=39 | Active, not recruiting | Sponsor: Shanghai Vitalgen BioPharma Co., Ltd. | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Jul 2031 ➔ Sep 2030 | Trial primary completion date: Jul 2027 ➔ Sep 2026

Enrollment closed • Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

VGN-R09b, an Adeno-associated virus-based Combination Gene Replacement Therapy for Parkinson's Disease (MDS Congress 2025) - "Efficacy and safety results from preclinical and preliminary clinical studies showed that VGN-R09b, an AADC and GDNF combination gene therapy is a promising novel treatment for PD. Figure 1 Figure 2 Figure 3 Figure 4 Figure 5"

CNS Disorders • Movement Disorders • Parkinson's Disease

A Trial to Evaluate Safety and Efficacy of a Product Named VGN-R09b in Patients With Parkinson's Disease (clinicaltrials.gov) - P1/2 | N=39 | Not yet recruiting | Sponsor: Shanghai Vitalgen BioPharma Co., Ltd.

New P1/2 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

A Trial to Evaluate Safety and Efficacy of a Product Named VGN-R09b in Severe AADC Deficiency (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Shanghai Vitalgen BioPharma Co., Ltd.

New P1 trial • Genetic Disorders

An Adeno-Associated Virus-Based Combination Gene Replacement Therapy for Parkinson's Disease (ASGCT 2023) - "Intra-striatal injection of VGN-R09b could dose-dependently improve the motor impairments, increase the striatal AADC activity, and protect the dopaminergic terminals in PD rodent and monkey models. Our preclinical data demonstrated the safety and efficacy of VGN-R09b and indicated its potential as an effective long-term treatment for PD."

Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Depression • Gene Therapies • Movement Disorders • Parkinson's Disease • Psychiatry • Sleep Disorder

An Early Clinical Trial to Evaluate VGN-R09b for Treatment of Aromatic L-amino Acid Decarboxylase (AADC) Deficiency. (clinicaltrials.gov) - P1 | N=6 | Recruiting | Sponsor: Shanghai Jiao Tong University School of Medicine

New P1 trial • Genetic Disorders