#Hemera biosciences full
#Hemera biosciences trial

There are currently no effective pharmaceutical treatments to enhance recovery in PNI. The work described in the project would establish preclinical proof-of-concept for the use of NVG-291-R to improve the rate and extent of nerve regeneration following peripheral nerve crush injury or transection followed by repair. announced it has been awarded up to USD 1.5 million in US Department of Defense (DoD) funding from the Military Operational Medicine Research Program (MOMRP/JPC-5) to evaluate NervGen's NVG-291-R as a therapeutic to enable accelerated and enhanced restoration of function following peripheral nerve injury. Receives Up to $1.5 Million US Department of Defense Funding to Evaluate NervGen's NVG-291-R for Peripheral Nerve Injury

#Hemera biosciences full

Pending successful completion of these preclinical safety studies and provision of available data from the ongoing Phase 1 study to the FDA, NervGen will seek full removal of the partial clinical hold. The additional preclinical safety studies requested by the FDA will further investigate the preclinical safety margin of NVG-291, testing exposures of NVG-291 higher than those tested in the follow-up preclinical safety studies. After the third and final dose cohort of postmenopausal females is completed, bridging cohorts of males and premenopausal females will be evaluated.

Results from the follow-up preclinical studies did not show adverse reproductive organ toxicity effects, including a repeat 28-day study, a 13-week study, and female and male fertility and early embryonic development studies. NervGen conducted the preclinical studies requested by the FDA, in addition to conducting longer 13-week studies.

The FDA requested additional preclinical safety data prior to inclusion of males and premenopausal females in the Phase 1 program. Under the partial clinical hold, NervGen was permitted to enroll females and postmenopausal females in the single ascending dose (SAD) and MAD portions of the study, respectively, and recently completed enrollment of the third and final MAD dose cohort. A partial clinical hold was placed on NVG-291 by the FDA in March 2020 when adverse dose- dependent reproductive organ toxicity results were observed in initial 7-day and 28-day preclinical toxicology studies.

#Hemera biosciences trial

Food and Drug Administration (FDA) has amended the partial clinical hold to permit the inclusion of males and premenopausal females at certain dose levels in the Company's Phase 1 clinical trial of NervGen's proprietary compound, NVG-291. Receives FDA Authorization to Expand Enrollment of Males and Premenopausal Females in Phase 1 Clinical Trial of NervGen's NVG-291