Sparian Biosciences Reports Phase 1 Trial Results for Novel Analgesic SBS-1000

Sparian Biosciences, Inc., a clinical-stage biopharmaceutical company that focuses on central nervous system (CNS) disorders, has announced the results from a Phase 1 clinical trial of its innovative arylepoxamide receptor (AEAr) agonist analgesic, SBS-1000. This study aimed to assess the safety, tolerability, and pharmacokinetic profile of SBS-1000 administered via intravenous infusion at various dosages to healthy adult volunteers.

Arylepoxamide receptors (AEAr) are a newly identified class of receptors distributed throughout the brain and spinal cord, believed to play a significant role in modulating pain signaling and perception. SBS-1000, the first AEAr agonist of its kind, has shown potent analgesic properties in pre-clinical models without the severe side effects commonly associated with opioids, such as respiratory depression, abuse potential, and physical dependence.

Jeff Reich, M.D., CEO and Co-Founder of Sparian, highlighted that in animal models, SBS-1000 has demonstrated strong analgesic effects with a notable safety profile. He expressed optimism that if these pre-clinical results can be replicated in clinical settings, SBS-1000 could potentially replace opioids for managing acute and chronic moderate to severe pain. Dr. Reich also noted that no new non-opioid analgesics with novel targets have yet shown comparable efficacy.

The Phase 1 Single Ascending Dose (SAD) study explored a range of doses in healthy volunteers. The study found no serious adverse events, and respiratory parameters such as respiratory rate, pulse oximetry, and end tidal CO2 remained within normal ranges at all doses. However, sedation at the higher doses was identified as the dose-limiting toxicity. This observation aligns with pre-clinical studies where sedation also appeared as a dose-limiting factor but showed improvement with repeated dosing. As this was a single dose study, tolerance to sedation over time was not evaluated.

The study also provided a complete pharmacokinetic profile of SBS-1000 intravenous infusion. Additionally, pharmacodynamic measurements included the Cold Pressor Test and pupillometry. The Cold Pressor Test, used to measure analgesia in healthy volunteers, indicated a positive trend towards efficacy, though it was not powered for statistical significance. Pupillometry, typically employed to measure off-target binding, particularly at the mu opioid receptor (MOR), revealed no significant changes in pupillary diameter at any dose, including those causing sedation, indicating no MOR activation.

Dr. Reich mentioned that while the results of the SAD study for SBS-1000 are promising, Sparian Biosciences is preparing to advance its next-generation AEAr agonist, SBS-147. Unlike SBS-1000, SBS-147 can be administered through various routes, not just intravenously. The company aims to submit an Investigational New Drug (IND) application by the following year for a combined Phase 1 SAD/Multiple Ascending Dose (MAD) trial.

SBS-1000's development has been supported by a grant from the National Institutes of Health/National Institute of Drug Abuse (NIH/NIDA). Sparian Biosciences, co-founded by Jeff Reich, M.D., and Gavril Pasternak, M.D., Ph.D., originated from Memorial Sloan Kettering Cancer Center. The company is focused on developing therapies for acute and chronic pain, opioid use disorder, acute opioid overdose, and stimulant use disorder, having received substantial NIH funding to support their research efforts.

Sparian Biosciences continues to work towards developing transformative therapies that address significant medical needs, aiming to provide safe and effective alternatives to current pain management options.