Silo Pharma, Inc. announced that based on positive SPC-15 pre-clinical data, it is working with Kymanox as its regulatory partner to assist with the preparation of a pre-Investigational New Drug (IND) package and meeting request with the United States Food and Drug Administration (FDA). SPC-15 is a targeted intranasal prophylactic intended for the treatment and prevention of anxiety, PTSD, and other stress-related disorders. Kymanox, a full-service life sciences solutions provider, will provide regulatory affairs support to the Company including the development of a clinical pharmacology and biopharmaceutics strategy and program to be proposed to the FDA.

A pre-IND meeting request for collaborative discussions with the FDA will be filed early 2024. SPC-15 utilizes metabolic biomarker profiling to treat anxiety, PTSD, and other stress-related disorders. Its core technology, which is patent-protected, predicts levels of severity and progression of such disorders and informs their response to pharmacological treatments and prevention. Kymanox is a life science professional services organization that offers engineering, scientific, project management, quality, human factors, testing /QC, CQV, and regulatory support to companies exclusively in the biotechnology, pharmaceutical, medical device, and combination product industries.  With its diverse team of experts, Kymanox helps clients navigate commercialization challenges that arise throughout a product?s life cycle ?

from early development to post-market ? with optimized safety, quality, efficacy, and accessibility. Kymanox was founded in 2004 and is headquartered in Morrisville, North Carolina USA.