Sparian Biosciences Announces IND Clearance of First-In-Class Arylepoxamide Agonist, SBS-1000, for the Treatment of Pain by the U.S. FDA

• SBS-1000 is the first arylepoxamide agonist for the treatment of pain to receive IND clearance
• Phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and analgesic efficacy of SBS-1000 will begin in 1Q2023
• SBS-1000 may present an alternative to opioids for the treatment of pain​​

Sparian Biosciences, Inc., a clinical-stage CNS-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to commence a phase 1 clinical trial of its first-in-class arylepoxamide receptor (AEAr) agonist, SBS-1000, for the treatment of pain. SBS-1000 is the first AEAr agonist to receive IND clearance from the FDA.

SBS-1000 targets the newly discovered AEA receptor (AEAr) in the pain pathway. In preclinical efficacy studies, SBS-1000 demonstrates potent analgesia in nociceptive, neuropathic, and inflammatory pain models. In preclinical safety studies, SBS-1000 does not demonstrate respiratory depression, physical dependence, or abuse liability as compared to morphine.

“The characterization of the AEAr and the development of arylepoxamide agonists represent a major new innovation in field of pain research,” said Jeffrey B. Reich, MD, Chief Executive Officer, Sparian Biosciences. “Our success so far has been the result of a productive collaboration with NIH/NIDA and we look forward to the start of our phase 1 trial.”

The phase 1 clinical trial will primarily evaluate the safety, tolerability, and pharmacokinetics of SBS-1000. In addition, the compound’s analgesic efficacy will be assessed using the Cold Pressor Test as an exploratory endpoint. More details about the trial design are available on www.clinicaltrials.gov.