Stroke is an acute event, which in many cases results in a lifelong injury. It occurs when blood supply to the brain is disrupted, preventing brain tissue from receiving oxygen and nutrients. Immediately following a stroke, acute and chronic pathologies, including inflammation, edema, and cell death, are triggered in the brain and throughout the body. NTS is developing novel therapeutics to target these pathological processes.
Brain Injury
Stroke: Major Unmet Medical Need
In the US, approximately 900,000 acute strokes occur annually. The thrombolytic agent, tissue plasminogen activator (tPA) is the only FDA-approved drug for treating acute stroke.
Stroke recovery can be a lifelong condition, causing significant disability, comorbidity and mortality. The prevalence of chronic stroke in the US is approximately 7-8M patients. These patients display a wide range of motor, sensorimotor, cognitive, neurobehavioral and systemic deficits.
AIS: Thrombolytics and mechanical thrombectomy are used within 4.5 and 24 h, respectively, for reestablishing blood flow; they are the only available therapies. Outside of the thrombolytics, there are no other approved AIS therapeutic options currently available.
SR: Similarly, there are no approved pharmacologic therapeutics for stroke recovery. In this space, small improvements in neurological outcomes are considered meaningful.
The annual direct health care cost burden of stroke is estimated at $103.5B in the US and $721B worldwide.
TBI: Major Unmet Medical Need
In the US, approximately 2.8M TBIs occur annually. The prevalence of TBI in the US is approximately 5.4M patients.
Similar to stroke, TBIs can result in lifelong disability and there are currently no approved therapies to treat TBI.
The annual direct health care cost burden of TBI is estimated at $48B in the US and >$400B worldwide.
Stroke and TBI vs Major Neurological Conditions
U.S. epidemiological data shows an alarming level of both incidence and prevalence for stroke and TBI in comparison to other major neurological conditions. There is a massive global unmet need for novel therapeutics in these areas.
NTS Success Criteria
Over 100 stroke neuroprotection clinical trials have failed, with each one deficient in multiple criteria. The lessons learned from these failures have provided invaluable contributions to guide NTS’ research and development strategy.
- Strong scientific basis
- Multi-targeted mechanism of action
- Independently verified pharmacology in models of AIS and brain injury
- Linear PK – efficient release of NTS-105 across species
- Penetrates CNS
- Strong safety profile in animals and humans
- High aqueous solubility-critical
- Manufacturability
- Commercial viability
- Strong intellectual property position
References
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Cramer et al. Stroke. 2023 Mar; 54(3): e86-e90.
Feigin et al. Int J Stroke. 2022 Jan; 17(1): 18-29.
Gladstone et al. Stroke. 2022 Aug; 33(8): 2123-2136.
Grupke et al. Clin Neuro. 2015 Feb; 129: 1-9.
Kidwell et al. Stroke. 2001 Jun; 32(6): 1349-1359.
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Lu et al. Life Sci. 2009 Sep; 85(11-12): 450-456.
Robba et al. Curr Opin Crit Care. 2020 Apr; 25(2) 137-146.