Silo Pharma and AmplifyBio Team up To Advance SPC-15 For Anxiety

Silo Pharma, biopharmaceutical firm focused on in the formation of novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments declared that it has secured a agreement to its its contract research organization (CRO) partner AmplifyBio to investigate new drug (IND) allowing large animal GLP (Good Laboratory Practice) study of its lead asset, SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD). 

The 28-day repeat intranasal dosing and 14-day recovery will be evaluated in the 4-week GLP study. SPC-15 demonstrated quick absorption and good exposure over a 24-hour period in a recent non-GLP small animal dose-ranging study with AmplifyBio, indicating a straightforward one-time human intranasal dose. In the beginning of 2023 and 2022, the business had previously signed agreements with AmplifyBio for research and development.

“Silo has partnered with AmplifyBio since 2022. Our longstanding collaboration has played a key role in advancing SPC-15 through multiple successful pre-clinical studies. A successful IND large animal GLP study is the final study that should facilitate seeking U.S. Food and Drug Administration (FDA) permission for first-in-human clinical studies in PTSD patients and would constitute a significant milestone achievement for the Company,” said Silo CEO Eric Weisblum.

This month, Silo requested a meeting with the FDA and a pre-IND briefing package for SPC-15. Before submitting an IND application to the FDA, one of the final steps is the IND-enabling GLP toxicology study.