NextGen, a company within the Artgen Biotech Group (MOEX: ABIO), announces a significant acceleration of the clinical trial timeline for a treatment for cystitis.
Based on the results of two Independent Data Monitoring Committees (IDMCs), the planned duration of clinical trials for the gene therapy drug Neovasculgen for the treatment of interstitial cystitis has been reduced by two years.
Following the first IDMC meeting, a decision was made to accelerate Phase II of the clinical trial by combining different patient cohorts: those receiving two and four administrations of the drug. This will reduce the planned trial duration by approximately one year.
Based on the results of the second IDMC meeting in December 2025, a decision was made to commence Phase III of the clinical trial without waiting for the completion of Phase II, as the safety of the gene therapy drug Neovasculgen in the treatment of interstitial cystitis can now be considered sufficiently proven. This will reduce the trial timeline by at least another year.
Furthermore, the second IDMC discussed preliminary positive data on the efficacy of Neovasculgen in the treatment of cystitis. This provides the Company with a chance for early registration of the new indication before the completion of Phase III studies.
Sergey Dale, Director of NextGen, noted: "Meticulous planning, organization, and execution of all exploratory, preclinical, and clinical studies enable the Company's R&D department to achieve its planned goals, reduce costs, and shorten time-to-market."
Interstitial cystitis is one of the most common causes of chronic pelvic pain. The disease causes frequent urination, incontinence, pelvic pain, and reduced social adaptation of patients. Worldwide, the number of patients with interstitial cystitis is 9.5 million people. In 2022, the disease was diagnosed in 180,000 patients in the Russian Federation, of which 20,000 were new cases.
In 70% of patients with interstitial cystitis, the disease is severe, requiring intensive treatment — prescription drugs and surgical intervention. In severe cases, with the development of irreversible changes in the interstitial layer of the bladder, patients experience urination frequency increasing to 50-60 or more times per day, blood in the urine, and significant psychiatric changes.
No effective therapy for the disease has yet been developed. Current treatment uses medication and surgical methods. However, there are no drugs on the market for the complete cure of interstitial cystitis.
Neovasculgen is actively used in practical healthcare for the treatment of lower limb ischemia. It is the world's first registered gene therapy drug with a mechanism of action based on "therapeutic angiogenesis" (vascular growth). Neovasculgen is included in the List of Vital and Essential Drugs, incorporated into national guidelines, federal clinical and statistical groups, and the Moscow Compulsory Health Insurance program.
Given that Neovasculgen stimulates therapeutic angiogenesis and is aimed at treating tissue ischemia, the drug has potential for treating other diseases where increased vascular network density is required — in particular, diabetic foot syndrome, interstitial cystitis, and alopecia. NextGen is currently focused on expanding the indications for the drug.
NextGen JSC is a resident of MedTech and a resident of the "Lomonosov" cluster of the Innovative Scientific and Technological Center of Moscow State University "Vorobyovy Gory". The company specializes in the development and implementation of gene therapy drugs and the expansion of indications for Neovasculgen.