Nyrada Inc (ASX: NYR), a preclinical stage, drug development company specialising in novel small molecule drugs to treat cardiovascular and neurological diseases, continues to progress its Brain Injury Program.
During preclinical development, NYR-BI02 was shown to be a potent blocker of TRPC ion channels, limiting excitotoxicity and secondary brain damage following a traumatic brain injury (TBI) or stroke.
However, Good Laboratory Practice (GLP) studies completed by the company demonstrated a sub-optimal safety profile for continuous dosing in patients with these conditions.
Following a review of over 200 available compounds generated by the company’s medicinal chemistry programme, NYR-BI03, a closely related analogue of NYR-BI02, was identified as having a superior safety profile along with better potency on the TRPC ion channel protein target, securing its selection as Nyrada’s new lead brain injury drug candidate.
The company has paused the preclinical GLP studies while a sufficient quantity of NYR-BI03 is manufactured. Additional slots have been secured at the Contract Research Organisation (CRO) contracted by Nyrada to undertake these studies later in the calendar year.
Strong results delivered through our medicinal chemistry program have allowed us to pivot quickly to a superior brain injury molecule to take forward into GLP studies and the TBI efficacy study that will be run at the Walter Reed Army Institute of Research,” CEO, James Bonnar, said.
“The exploratory studies using NYR-BI03 gives us confidence it is the optimal drug candidate to take into clinical development. We are working closely with our CRO to expedite the manufacture of NYR-BI03 ahead of commencing the preclinical, TBI efficacy and stroke model studies in the second half of this year,” Mr Bonnar added.
Nyrada’s abstract on the TRPC channel ion channel blocker has been accepted for presentation at the MHSRS conference being held in August in Florida, US. The MHSRS is the Department of Defense’s foremost scientific meeting, focusing specifically on the unique medical needs of military personnel, drawing approximately 3,500 attendees.
With one in five military service members suffering a TBI, developing the first ever drug to treat this injury is a key priority for the Department of Defense. The invitation to present at the Symposium is recognition of the potential for Nyrada’s Brain Injury Programme to positively impact the lives of those who have been affected by TBI.
NYR-BI03 replaces NYR-BI02 as the compound to be tested in the Walter Reed Army Institute of Research (WRAIR) TBI efficacy study and stroke model study to be run in the second half of the year. The progress of the stroke model study had to be halted when the limitations of NYR-BI02 were identified.