Pre-IND submission to FDA targeted for first quarter 2024
Silo partners with Kymanox for SPC-15
Silo Pharma, Inc. (Nasdaq: SILO) (“the Company”), a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research, today 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.
“Our pre-clinical data indicate that SPC-15 has additive benefits for combating stress-induced pathophysiology, both at the behavioral and neural levels. In conjunction with Columbia University, we are pleased to announce this milestone in advancing our potential therapeutic development for those suffering from stress-induced anxiety and PTSD. We are confident that our own pre-clinical work coupled with published preclinical data provides a strong foundation for our pre-IND application, which we plan to submit during the first quarter of 2024.”
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. For more information, visit www.kymanox.com.
Silo Pharma. Inc. is a development-stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research for people suffering from indications such as PTSD, Alzheimer’s disease, and other rare neurological disorders. Silo’s mission is to identify assets to license and fund the research which we believe will be transformative to the well-being of patients and the healthcare industry. For more information visit www.silopharma.com