- NervGen Pharma Corp. (NGEN) updates its Phase 1 program with NVG-291
- It includes new data for the highest single ascending dose (SAD) cohort that demonstrated NVG-291 was well tolerated and had favorable pharmacokinetic properties
- NVG-291 was well tolerated at doses higher than the dose equivalent in animal models of spinal cord injury and multiple sclerosis, where dramatic recoveries were recorded
- NervGen also announces its completion of its six planned SAD cohorts
- The company will proceed to the multiple ascending dose (MAD) portion of the study pending approval of the SAD portion of the Phase 1 trial by the ethics review committee
- NervGen Pharma Corp. is down 1.754 per cent and is trading at $2.80 per share at 2:42 p.m. ET
NervGen Pharma Corp. (NGEN), a clinical-stage biotech company, has provided updates on its Phase 1 program with NVG-291.
NervGen’s Chief Medical Officer, Dr. Daniel Mikol, presented blinded safety and pharmacokinetic data.
It includes new data for the highest single ascending dose (SAD) cohort that demonstrated NVG-291 was well tolerated and had favourable pharmacokinetic properties.
NVG-291 was well tolerated at doses higher than the dose equivalent in animal models of spinal cord injury and multiple sclerosis, where dramatic recoveries were recorded.
NervGen has also announced the completion of its six planned SAD cohorts.
The safety review committee overseeing the study has recommended the company proceed to the multiple ascending dose (MAD) portion of the trial.
Blinded safety data was provided from 37 healthy volunteers who participated in the six cohorts of the SAD portion of the study and have been treated with either placebo or NVG-291.
All reported adverse events have been mild and transient and there were no observed effects on vital signs, electrocardiograms or laboratory assessments.
Subjects were dosed as high as 0.864 milligrams per kilogram, which, when using the appropriate dose conversion model, is 170 per cent more than the highest effective dose studied in the various animal models of nervous system injury.
The company will proceed to the MAD portion of the study pending approval of the SAD portion of the Phase 1 trial by the ethics review committee.
Subjects will be dosed in a blinded fashion with NVG-291 or placebo once a day for 14 consecutive days.
The MAD portion of the study is expected to include three dose cohorts and be completed in early 2022.
Following the completion of the MAD study, NervGen will seek removal of the partial clinical trial hold initiated by the FDA and perform bridging studies in healthy males and in healthy premenopausal females.
NervGen Pharma Corp. is down 1.754 per cent and is trading at $2.80 per share at 2:42 p.m. ET.