At Neuro-Innovators (NIV), we engineer drugs to accelerate brain neuroplasticity (the capacity of the brain to remodel, rewire, and recover) for patients with brain injuries and diseases. Our first combinational drug, NIV-001, is for patients with chronic impairments after stroke (Chronic Stroke). NIV-001 combines three existing FDA-approved drugs, each with well-studied neuroplastic properties.

Medically prescribed drugs in the US must be approved by the Food and Drug Administration (FDA), as specified by the Food, Drug and Cosmetic Act of 1938. Brand new drugs are filed for approval with the FDA through the 505(b)(1) new drug applications (NDAs).

The 505(b)(2) NDA regulatory pathway evaluates drugs that have been previously approved by the FDA but for a different indication. The 505(b)(2) route was introduced by the Hatch-Waxman Amendments of 1984 to avoid unnecessary duplication of research. The fast-track 505(b)(2) pathway permits drug companies to apply for approval using existing public data in lieu of conducting studies.

Note that 505(b)(2) filings are initiated with a pre-IND meeting. The objective of a 505(b)(2) pre-IND meeting is to gain input from the FDA and consensus on the studies required; plans for clinical research; and the chemistry, manufacturing, and controls (CMC) strategy in order to minimize the number of new studies required for approval.

We are preparing for our pre-IND meeting with the FDA prior to beginning Phase II trials (the drug trials completed initially by each of the drugs in their prior approvals are to stand in for our Phase I trials).