Pittsburgh Company Collaborates with Spaulding Rehabilitation to Study its New Combination Drug to Help Chronic Stroke Survivors Regain Brain and Motor Function

Pittsburgh Company Collaborates with Spaulding Rehabilitation to Study its New Combination Drug to Help Chronic Stroke Survivors Regain Brain and Motor Function

For Immediate Release

Neuro-Innovators, LLC Contact: Jack Schroeder
804 Persimmon Rd. j.schroeder@neuro-innovators.com
Sewickley, PA  15143 (412) 759-9953


Pittsburgh Company Collaborates with Spaulding Rehabilitation to Study its New Combination Drug to Help Chronic Stroke Survivors Regain Brain and Motor Function

Pittsburgh, PA: [May 22, 2024] Neuro-Innovators, LLC (“NIV-Neuro”), a clinical stage, Pittsburgh-based pharmaceutical company engineering drugs to enhance neuroplasticity, announces a collaboration with Spaulding Rehabilitation Hospital (“Spaulding”), a member of the Mass General Brigham healthcare system. Spaulding and NIV-Neuro are working together with a goal to help millions of stroke survivors’ brains rewire, rebuild, repair, and heal, by improving neuroplasticity, the brain’s capacity to create new connections in response to intrinsic or extrinsic stimuli.

Under a Master Research Agreement signed in February, NIV-Neuro will launch its first study, a Phase 2(a) Investigator Initiated/Proof of Concept study, to evaluate the effectiveness of its lead candidate, NIV-001, a combination drug engineered to enhance the brain’s neuroplasticity in conjunction with active stroke therapy. 

NIV-001 is a three-drug combination of medications that already have earned FDA approval; each has proven to impact mechanisms of neuroplasticity, are known to be safe, and, when repurposed and used together in conjunction with active stroke therapy, holds promise to be even more impactful. It will come in the form of a once-a-day pill to be taken concurrently with the patient’s prescribed physical/occupational stroke therapy. NIV-Neuro’s goal is to efficiently commercialize novel compound drugs engineered to enhance the brain’s neuroplasticity without hallucinogenic side effects.

Because the three drugs that comprise NIV-001 already have earned FDA approval, the company has been able to build a low-risk strategy for neuro drug commercialization.

“NIV-Neuro is and will continue to capitalize on its first-mover position in the burgeoning neuroplastic space, by developing safe drugs concurrently targeting multiple mechanisms of plasticity and enabling more effective neurologic drugs for today and tomorrow,” said NIV-Neuro Co-Founder & CEO Howison Schroeder. 

The lead investigator for this study is Spaulding’s Paolo Bonato, Ph.D., Director of its Motion Analysis Laboratory, along with Dr. Qing Mei Wang, M.D., Ph.D., a physician investigator in the Department of Physical Medicine and Rehabilitation at Mass General Research Institute. Their abundant publications on stroke and stroke rehabilitation (with and without pharmaceuticals) make them excellent collaborators for this research. 

“We are excited to evaluate the potential of a new therapeutic combination to help stroke survivors recover motor function,” said Dr. Qing Mei Wang and Dr. Paolo Bonato. “Stroke is a leading cause of long-term disability, and therapeutics that enhance rehabilitation and recovery are of great need.”

Through extensive research, NIV-Neuro has gathered existing pre-clinical and clinical data supporting a strategy that concurrent targeting of these mechanisms will result in an increase of the brain’s ability to rebuild, restore, rewire, and heal, thereby allowing improvement in the response to therapies for motor disfunction for stroke survivors who are six months and beyond post-stroke. 

This target population, stroke survivors with motor disabilities six or more months post-stroke, have been generally warehoused due to the absence of any standard of care or clinically accepted therapies to improve their condition. The population, nearly 7 million in the U.S. alone, represents a significant unmet need, estimated to represent a market of greater than $20 billion. 

The study is designed to evaluate prospects and valuation inflection point milestones. Study design includes 40 patients at 10-patient increments, who will complete an eight-week stroke rehabilitation protocol while taking a daily dose of NIV-001. Upon successful completion of this study, expected no later than year-end 2025, NIV-Neuro expects to begin a Phase 2(b) dosing study for the final configuration of NIV-001. NIV-Neuro is planning a 505(b)(2) fast track pathway with the FDA. 

“Working with Spaulding’s Drs. Bonato and Wang has been fabulous,” said Mark Cochran, Ph.D., Director and COO of NIV-Neuro. “They are bringing vast experiences from numerous prior studies they have conducted, which informs their study of our combination drug.”

The clinical endpoint for the study will be a measurable difference in the widely accepted Fugl-Meyer Assessment Upper Extremity (FMA-UE) Score, a metric heavily dependent on objective motor function measurements, showing at least a 5-point, out of a possible 66-point, change in function. 

Schroeder said management believes successful completion of the Phase 2(a) study in late 2025 represents another milestone for NIV-Neuro, one that could generate substantial acquisition or partnership interests.

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Neuro-Innovators, LLC is a clinical-stage pharmaceutical company whose mission is to engineer compound drugs that engage multiple mechanisms of plasticity to enhance the healing, rewiring, and rebuilding of human brains. NIV-Neuro’s goal is to improve the lives of millions of patients suffering from brain traumas, strokes, or a range of neurologic diseases, addressing substantial unmet need and lessening the large financial and emotional burden. For more information, visit NIV-Neuro.