- NervGen Pharma (NGEN) receives ethics board approval for multiple ascending dose portion of NVG-291 Phase 1 Trial
- Phase 1 program supports plan to start clinical trials in H2 2022 for NervGen’s NVG-291 in spinal cord injury, multiple sclerosis and Alzheimer’s disease indications
- Screening of healthy volunteers has already started for the trial’s multiple ascending dose (MAD) portion
- In preclinical studies, NVG-291 has been shown to promote repair of nervous system damage
- NervGen Pharma Corp. (NGEN) is down 4.07 per cent and is trading at C$2.59 at 12:25 pm EST
NervGen Pharma (NGEN) has received approval from Bellberry Limited’s Human Research Ethics Committee (HREC) to proceed with its Phase 1 NVG-291 trial.
In preclinical studies, NVG-291 has been demonstrated to promote repair mechanisms in the nervous system, including axonal regeneration, remyelination and enhanced plasticity.
NervGen is now screening healthy volunteers for participation in the multiple dosing portion of the trial and expects to dose the first subjects early in 2022.
“Commencing the MAD portion of our Phase 1 trial is an important milestone for the development of NVG-291,” stated Dr. Daniel Mikol, NervGen’s Chief Medical Officer.
“Completing the MAD portion of the study is an important step as we move towards our Phase 1b/2 studies in spinal cord injury, multiple sclerosis and Alzheimer’s disease, which we plan to start in the second half of 2022,” added Mikol.
The MAD portion of the Phase 1 study will administer NVG-291 or a placebo in a blinded fashion once a day for 14 consecutive days. The study is expected to complete the three planned dose cohorts in the first half of 2022.
Following completion of ongoing toxicology studies requested by the US Food and Drug Administration (FDA) and provision of available data from this Phase 1 study to the FDA, NervGen will seek removal of the partial clinical trial hold initiated by the FDA and evaluate the safety and pharmacokinetics of NVG-291 in cohorts of healthy males and healthy premenopausal females.
NervGen is enabling the nervous system to repair itself by creating innovative treatments of nervous system injury due to trauma or disease. It is initially developing treatments for multiple sclerosis, spinal cord injury and Alzheimer’s disease.
NervGen holds the exclusive worldwide rights to NVG-291 and is developing a unique new class of drugs around the technology. NVG-291 is a therapeutic peptide that is a mimetic of the intracellular domain of protein tyrosine phosphatase, a cell surface receptor known to interact with chondroitin sulphate proteoglycans and to be involved in the regulation of neuroplasticity and central nervous system repair.
NervGen Pharma Corp. (NGEN) is down 4.07 per cent and is trading at C$2.59 at 12:25 pm EST.