Silo Pharma, Inc. (Nasdaq: SILO), a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research, today announced initial dosing in its IND-enabling study of SP-26, its novel time-released, topical formulation of ketamine.
The objective of this safety evaluation study, conducted by Experimur, a Frontage Company, is to evaluate the tolerability of the SP-26 compound to establish a maximum tolerated dose. The new drug is intended to treat fibromyalgia, a chronic condition causing widespread musculoskeletal pain accompanied by memory issues, sleep problems and fatigue.
“Our team is excited about this milestone in our collaboration with our joint venture partner Zylö Therapeutics, headquartered in South Carolina. Together we have developed a delivery method for a new ketamine formulation that has shown in pre-clinical studies to hold and distribute the drug in a time-released fashion and reduce neuropathic nerve pain. This IND-enabling study coupled with our existing data brings us another step closer to testing in human patients.”Eric Weisblum, Chief Executive Officer of Silo Pharma
Silo Pharma recently began working with a regulatory partner to prepare a pre-Investigational new drug (IND) package submission to the U.S. Food and Drug Administration (FDA). The Company intends to pursue the 505(b)(2) regulatory pathway for SP-26.
Silo cites that according to Fortune Business Insights, the market for fibromyalgia treatments was valued at US$764 million in 2020 and will be worth US$1.4 billion in 2027 with a compound annual growth rate (CAGR) of 9.2 per cent over the next five years.
About Silo Pharma
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.