- NervGen Pharma Corp (NGEN) has received approval for the clinical trial of NVG-291 from the Bellberry Human Research Ethics Committee in Australia
- The study protocol was also previously reviewed by the U.S. Food and Drug Administration
- NVG-291 is an inhibitor of PTPσ, a promising target for reducing the clinical effects of nerve damage
- NervGen believes that inhibiting the activity of PTPσ has the potential to promote nerve regeneration and remyelination of damaged nerves
- NervGen Pharma Corp (NGEN) is up 4.29 per cent, trading at C$1.70 per share at 10 am ET
NervGen Pharma Corp (NGEN) has received approval for the clinical trial of NVG-291, a specific and selective protein tyrosine phosphatase sigma inhibitor.
The approval was granted by Bellberry Human Research Ethics Committee (“HREC”) in Australia.
“We are pleased that the HREC found our modified development program to be acceptable and the receipt of ethics approval marks a significant milestone in the advancement of NVG-291 into the clinic,” stated Paul Brennan, NervGen’s President & CEO.
“We intend to build on this momentum and look forward to evaluating the therapeutic potential of NVG-291 in patients upon successful completion of the Phase 1 trial in healthy volunteers.”
The Therapeutic Goods Administration in Australia has been notified of the study through the Clinical Trial Notification Scheme.
The study protocol was also previously reviewed by the U.S. Food and Drug Administration (“FDA”). The protocol is intended to support the progression of a clinical study in the U.S. and Australia.
Following modifications to the Phase 1 protocol, NervGen has been cleared by the FDA to proceed with the single ascending dose portion of the trial in females, and the multiple ascending dose portion of the trial in post-menopausal females.
This FDA clearance also supports the review by the HREC in Australia. NervGen remains on track to dose the first human subjects in Australia in Q2 2021.
NVG-291 is an inhibitor of PTPσ, a promising target for reducing the clinical effects of nerve damage, either as a result of trauma, such as spinal cord injury, traumatic brain injury or stroke, or neurodegenerative diseases, such as multiple sclerosis or Alzheimer’s disease.
NervGen believes that inhibiting the activity of PTPσ has the potential to promote nerve regeneration and remyelination of damaged nerves.
NervGen creates innovative solutions for the treatment of nerve damage and neurodegenerative diseases. The company is developing drugs for the treatment of multiple sclerosis, spinal cord injury and Alzheimer’s disease.
NervGen’s platform technology targets protein tyrosine phosphatase sigma (“PTPσ”), a neural receptor that impedes nerve repair.
NervGen Pharma Corp (NGEN) is up 4.29 per cent, trading at C$1.70 per share at 10 am ET.
