NervGen Pharma Advances NVG-300 to Preclinical Proof-of-Concept Stage

NervGen Pharma Corp. has announced its intention to develop a novel biologic molecule, NVG-300, which targets ischemic stroke, amyotrophic lateral sclerosis (ALS), and spinal cord injury (SCI). This development is part of the company's broader strategy to address major unmet needs in neurological disorders. NVG-300, discovered in 2022, promises to advance NervGen's mission to pioneer treatments that facilitate the repair of the nervous system following damage.

NVG-300's development will adhere to the Biologics License Application regulatory framework, ensuring it receives 12 years of market exclusivity upon approval. Intellectual property protections for NVG-300 are also projected to extend beyond 2040, securing a long-term competitive advantage for NervGen. The discovery of NVG-300 leverages NervGen's internal expertise and evolving scientific insights into nervous system repair mechanisms. It signifies the company's commitment to developing a pipeline of molecules aimed at critical neurological disorders.

The manufacturability and feasibility of NVG-300 have progressed sufficiently to support its development in a liquid formulation suitable for self-administration via prefilled syringes. This convenient delivery method is anticipated to enhance patient compliance and accessibility.

Dr. Matvey Lukashev, NervGen's Vice President of Research and Preclinical Development, highlighted the molecule's promising efficacy in a severe SCI model, which showed substantial damage and impaired recovery. This success has prompted further preclinical evaluations of NVG-300 in SCI, alongside initiating efficacy studies in preclinical models of ischemic stroke and ALS. The outcomes of these preclinical studies are anticipated in early 2025, which will be pivotal for the molecule's future development.

Mike Kelly, NervGen's President and CEO, expressed confidence in NVG-300's potential to diversify the company's pipeline and provide strategic opportunities for future partnerships. While NVG-291 remains the company's primary focus, NVG-300 represents a promising addition that could address significant gaps in current treatment options for neurological damage.

Ischemic stroke remains a leading cause of death and severe disability globally, with nearly 17 million cases annually. Current treatments for ischemic stroke, such as tissue plasminogen activator and surgical clot removal, are time-sensitive and limited in availability. This scarcity of effective treatment options underscores the urgent need for innovative solutions like NVG-300.

ALS, a progressive neurodegenerative disorder, results in the loss of motor neurons and voluntary muscle function, typically leading to respiratory failure and death within 2-5 years after diagnosis. With an estimated 30,000 individuals affected in the United States and over 30,000 in Europe, ALS represents a significant unmet medical need.

SCI, often resulting from trauma, disrupts communication between the brain and body, causing severe impairment below the injury site. Each year, up to 500,000 people globally suffer from SCI, facing lifetime care costs ranging from $1M to $4M. Current treatments are limited to surgical stabilization and physical rehabilitation, which offer only partial recovery. There are no FDA-approved treatments available that promote repair and functional improvement after SCI.

NervGen Pharma Corp. continues to position itself as a leader in developing pharmacological interventions that target the mechanisms inhibiting nervous system repair. By focusing on innovative treatments like NVG-300, the company aims to remain at the forefront of this emerging therapeutic field and significantly impact the lives of individuals suffering from neurological damage.