We are continuing the development of the drug Ronopterin for patients suffering from acute, severely debilitating and life-threatening diseases.
veriNOS’ lead product Ronopterin is in late-stage clinical development.
Ronopterin is the first and only selective inhibitor of inducible Nitric Oxide Synthase (iNOS) which has repeatedly shown signs of biochemical and clinical neuroprotection in patients with traumatic brain injury (TBI).
In two late-stage clinical trials Ronopterin significantly reduced brain glutamate in the human injured brain (microdialysis), reduced therapy aggressiveness, improved neurological outcome (extended Glasgow Outcomes Scale, eGOS), and improved Quality of Life (QOLIBRI).
There is strong enthusiasm and support from Key Opinion Leaders (KOLs) and treating physicians, with a clear regulatory pathway for marketing authorization in the EU and US for the treatment of TBI. TBI data is expected in 3 years with potential treatment options in 4 years.
The mechanism of action of Ronopterin, particularly the reduction of elevated brain glutamate carries strong potential for a neuroprotective franchise in other indications such as reduction of life-threatening brain edema in neuro-oncology and vision-impairing retinal edema in ophthalmology addressing the high unmet medical needs in these areas.
KOL support enables rapid access to cost-effective proof of concept (POC) studies in these broader indications with results possible in short-term time frames.
New IP has been filed which extends protection until 2042 with orphan drug designation in the EU and 10 years market exclusivity for TBI.