MIAMI--(BUSINESS WIRE)--ECP Pharma has received a favorable, positive written response from the FDA regarding its Pre-IND submission of novel drugs for targeted indications with no clinically proven treatment options using underutilized APIs (Active Pharmaceutical Ingredients).
The FDA provided a clear order of when clinical studies should be conducted by ECP Pharma, which increases the likelihood of successful sequential program development. The battery of nonclinical studies will help to inform the clinical program, which will now follow an outline from the FDA on the requirements needed to commence with its clinical trials. One initial takeaway is that the FDA is supportive of the development of this combination drug therapy program for Neurological and CNS diseases.
"The Pre-IND meeting notes are a wonderful indicator that ECP Pharma is on the right track,” says Dr. Michael Hoffer, ECP Pharma’s Chief Medical Officer and a Professor of Otolaryngology and Neurological Surgery at the University of Miami. “The FDA’s feedback provides a clear path forward which will alleviate future headaches with the inclusion of nonclinical feedback to help avoid a Clinical Hold when the IND is submitted. We expect to be on schedule to start first in human trials after our IND submission.”
According to Dr. Hoffer, ECP Pharma’s focus and areas of research target the field of neuroscience and neurology to identify target indications to develop a robust drug product development pipeline. Its drug discovery process and business development analytics are backed by world-class experts in the fields of drug research, regulatory compliance, and business management. The company’s unique collaboration with the University of Miami’s Miller School of Medicine through research agreements provides another strategic edge for ECP Pharma.
The ECP Pharma clinical trials team is currently in discussions with regulatory agencies in North and South America to be able to undergo multiple comprehensive, inclusive trials in addition to Phase 1 and 2 clinical trials set to begin in Miami, Florida. Several new FDA approved diagnostic technologies that the company is utilizing will allow it to quantify the improvement in each patient’s condition after the treatment course has been administered.
ECP Pharma’s unique product pipeline uses a combination of cannabinoids, psychedelics and other compounds to therapeutically treat disease indications from which millions of patients suffer worldwide. Founded in March 2019, ECP Pharma is a global company with operations in the United States, Canada, and Latin America that is committed to research, development & manufacturing of innovative drug products that enhance human life. For more information about ECP Pharma and its work across multiple clinical and functional areas go to www.ecppharma.com.
ECP Pharma Inc. is a clinical-stage pharmaceutical company focused on treating neurological and CNS diseases. The Company's product pipeline includes drugs derived from cannabinoids, psychedelic and other compounds to offer potential therapeutic benefit to multiple central nervous system diseases such as spasticity for Multiple Sclerosis, mild cognitive impairment for early on set of Alzheimer’s Disease and mild Traumatic Brain Injury (mTBI). More information may be found on the company's website www.ecppharma.com.