Nextgen (part of the Artgen Biotech group, MOEX: ABIO) received permission from the Ministry of Health of the Russian Federation to conduct clinical trials of the gene therapy drug Neovasculgen for the treatment of interstitial cystitis (bladder pain syndrome - a chronic, disabling disease in adults, currently considered incurable).
According to preclinical studies, intramuscular administration of the drug has a positive therapeutic effect on indicators of experimental pathology - a model of interstitial cystitis.
Interstitial cystitis is one of the most common causes of chronic pelvic pain. The disease causes frequent urination and urgency with incontinence, significant pelvic pain, decreased social adaptation of patients.
In 30% of patients, the disease manifests itself in mild to moderate form. The disease can be managed with lifestyle changes and over-the-counter medications. In 70% of patients with interstitial cystitis, the disease is severe and patients require more intensive treatment - prescription medications, surgery. In severe cases, with the development of irreversible changes in the interstitial layer of the bladder, patients experience an increase in urination up to 50-60 or more times a day, patients are bothered by imperative urges, the appearance of blood in the urine, and significant mental changes are observed. According to American scientists, the prevalence of suicidal risk among patients with severe interstitial cystitis is 38.1%.
Effective therapy for the disease has not yet been developed. Treatment uses medications and surgical methods. However, there are no drugs on the market to cure interstitial cystitis completely.
In total, the number of patients with interstitial cystitis in the world is 9.5 million people. In 2022, the disease was diagnosed in 180 thousand patients in the Russian Federation, of which 20 thousand became newly ill.
The "interstitial cystitis" disease has two key types: with ulcerative lesions of the mucous membrane of the bladder, the so-called Hunner's lesions, and without them. The approaches to diagnosis and therapy differ, so the study will be conducted in parallel for the first and the second types of patients.
Neovasculgen drug is actively used in practical healthcare for the treatment of ischemia of the lower extremities. This is the world's first gene therapy drug registered in the Russian Federation with the "therapeutic angiogenesis" mechanism of action (curative vascular growth). Nevasculgen is included in the list of vital and essential drugs, included in national recommendations, federal clinical and statistical groups, and the Moscow compulsory medical insurance program.
Due to the fact that Neovasculgen stimulates therapeutic angiogenesis and targets the treatment of tissue ischemia, the drug has potential for the treatment of other diseases that require an increase in the density of the vascular network - in particular, interstitial cystitis. NextGen is focused on expanding the indications for drug use.
In order to study the effectiveness of therapeutic angiogenesis for the treatment of patients with interstitial cystitis comprehensively, Nextgen will conduct clinical trials of the drug using two protocols:
- Double-blind, placebo-controlled, adaptive, multicenter, prospective, randomized, comparative, parallel group study of the effectiveness and safety of Neovasculgen in bladder pain syndrome/interstitial cystitis, without Hunner's lesions.
- Double-blind, placebo-controlled, adaptive, multicenter, prospective, randomized, comparative, parallel group study of the effectiveness and safety of Neovasculgen in bladder pain syndrome/interstitial cystitis, with Hunner's lesions.
Nextgen is a resident of Medtech, a resident of the Lomonosov cluster of the "Sparrow Hills" Innovative Science and Technology Center of the Moscow State University. The company is engaged in the development and implementation of gene therapy drugs, expanding the indications for use of the Neovasculgen drug.