Silo Pharma (NASDAQ:SILO) has announced the initiation of a preclinical pharmacokinetic (PK) and tolerability study, in partnership with AmplifyBio, to assess Silo’s dissolvable, ketamine-based injectable implant, SP-26 in a minipig model.
The company states that SP-26 is being developed as a self-administered, non-opioid therapeutic aimed at treating chronic pain and fibromyalgia. The non-GLP study, set to span three weeks, will investigate the absorption, distribution, metabolism, and excretion of extended-release ketamine hydrochloride implants. Two distinct polymer formulations will be tested at varying dose levels.
“So far this year we have conducted several studies of our SP-26 ketamine implants including analytical testing and small batch proof-of-concept extrusion trials, manufacturing and production evaluation, and sterilization and dissolution tests, with what we believe are encouraging results,” said Eric Weisblum, CEO of Silo.
“The advancement of this program into animal studies is an important milestone achievement as we work to bring a safe and effective and to our knowledge, first-of-its-kind ketamine treatment for those living with chronic pain,” Mr. Weisblum added.
Jerry Hacker, EVP and CCO of AmplifyBio, commented, “AmplifyBio is honored to support Silo Pharma in this critical safety milestone for SP-26. We understand and take seriously the trust put in us to execute the PK study efficiently and with excellence.”
