German cerebrovascular specialist Vasopharm has announced a statistically-significant result from post hoc analyses of its clinical trial program for ronopterin.
The company is running the Phase II NOSTRA and Phase III NOSTRA III trials of the candidate, an analog of the natural cofactor tetrahydrobiopterin, to evaluate its potential in traumatic brain injury (TBI).
The new analyses show reduced brain microdialysate glutamate levels. The firm noted that increased glutamate levels are “associated with evolving cell damage and poor prognosis.”
Lead investigator Andreas Unterberg said: “This significant reduction of glutamate in TBI patients is impressive, especially in view of the long-standing attempts to reduce elevated glutamate levels where other compounds have failed due to unacceptable side effects or lack of efficacy.”
He added: “It appears that the dual effects of reducing iNOS activity and glutamate release are ronopterin’s very promising mode of action.”
The company said the results provided a strong basis to expand its clinical development plans.
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