Neuro-Innovators is a clinical-stage drug company focused on engineering drugs to accelerate brain neuroplasticity (i.e., the capacity of the brain to remodel, rewire, and recover) for patients suffering with brain injuries and diseases. For our first neuroplasticity target, we have created a combinational drug designed for patients with chronic motor deficits from stroke (Chronic Stroke). Our three-drug combination (NIV-001) is designed to increase brain plasticity via multiple mechanisms of action or pathways within the brain. Historically, stroke patients have undergone repetitive exercise and stimulation therapies to help restore some functions. While those therapies help, most patients are still left with clinical deficits in motion, speech, cognition, and other critical functions. NIV-001 is a pharmacological solution to be used in conjunction with physical therapies to improve patient outcomes significantly.
We are preparing a clinical study for our drug (NIV-001) to present to the FDA in a pre-IND meeting. Our study design is based on the FDA’s 505(b)(2) filing process, a fast-track approval mechanism established under the Food, Drug, and Cosmetic Act. Since NIV-001 incorporates three drugs, each of which has been approved by the FDA for other indications, we plan to begin Phase II trials with the consent of the FDA. (Note that the drug trials completed initially by each of the drugs in their prior approvals are to stand-in for our Phase I trials). With the fast-track FDA filing, we expect our time to commercialization to be reduced by 30% to 50% relative to a brand-new drug and our drug trial costs to be reduced by 90%. These are strong competitive advantages for NIV and will permit us to move more quickly when we prepare combinational drugs for other brain injuries and diseases.
Neuroplastic medicine can alleviate patient suffering from a multitude of brain impairments, including injuries to the central nervous system, dementia and movement disorders, depressions, immune system attacks, neuro-psychiatric disorders, and cognitive deficits. We expect Traumatic Brain Injury and Concussion to be our second target with the development of the drug NIV-002.
With three co-founders, seven other professional staff members from a wide range of disciplines, and a Scientific Advisory Board, NIV possesses the management, operational, and financial skills it needs to succeed. Further, we have and will continue to protect NIV intellectual property through trade secrets and multiple new patents.
We are headquartered in the Pittsburgh, Pennsylvania area. We welcome your interest. To get in touch, please contact Howison Schroeder, CEO, at 412-427-0988 or through email at h.schroeder@niv-neuro.com.