PIPELINE IN A PRODUCT
NoNO’s initial focus is stroke. Nerinetide and its subsequent analogs have been tailored to offer opportunities for a better life to increasingly large numbers of people who have experienced a stroke. We anticipate a registration-ready package for our initial indication upon completion of ESCAPE-NEXT for people experiencing an acute ischemic stroke, followed by expansion to those also receiving thrombolytics, to those treated outside a hospital setting, and ultimately to the majority of the 101 million stroke survivors who remain on the road to recovery.
NoNO’s pipeline delivers on the promise of neuroprotection and neurorestoration across a broad range of indications. The same fundamental new mechanism in neuroscience of PSD-95 inhibition that offers opportunities for a better life to people following stroke may benefit people who have experienced other brain injuries. Researchers worldwide have confirmed the potential benefits of PSD-95 inhibition not only in stroke but also subarachnoid hemorrhage, traumatic brain injury and concussion, retinal ischemia and dementia including Alzheimer’s disease.
initial Focus on Stroke
Initially, NoNO has focused on protecting the brain against the damaging effects of a stroke during the emergency phase and restoring function once a stroke has occurred. Treating stroke remains one of the grand challenges of biotechnology. It is the second leading cause of death worldwide and the leading cause of neurological disability, greater than all dementias combined, including Alzheimer’s. Beginning with our lead product nerinetide, our pipeline directly addresses ever greater population segments of this massive unmet medical need.
Nerinetide is a 20 amino acid peptide intended for intravenous infusion to improve outcomes for people who have experienced an acute ischemic stroke. Hospitals in the US alone treat approximately 800,000 strokes per year, of which only about 10% ever return to life as it was before. In the global Phase 3 ESCAPE-NA1 study of 1105 participants, when compared to placebo in people experiencing an acute ischemic stroke and not receiving alteplase, a single dose of nerinetide given within 12 hours of symptom onset improved functional independence at 90 days by almost 20%, reduced infarct volume by 22% and lowered mortality by 40%. NoNO is currently completing the registrational Phase 3 ESCAPE-NEXT study in people experiencing an acute ischemic stroke who are selected for endovascular thrombectomy as well as the pre-hospital FRONTIER study for suspected stroke.
NoNO-42 is a nerinetide analog presently in Phase 1 for use in people experiencing an acute ischemic stroke with or without thrombolytics. Of the 650,000 people experiencing an acute ischemic stroke treated annually in US hospitals, approximately 10% receive a thrombolytic, which may reduce the applicability of nerinetide. Compatibility of NoNO-42 with thrombolytics broadens the availability neuroprotection and neurorestoration to all hospital treated strokes.
NoNO-SC is a subcutaneously injectable nerinetide analog for the treatment of all strokes. Autoinjector compatibility (i.e. a “stroke pen”) enables administration by any caregiver at home, en route to the hospital or upon arrival in the emergency department.