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Press Release

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

By February 9, 2023September 24th, 2024No Comments
  • 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.

Sparian Biosciences is a clinical-stage CNS-focused biopharmaceutical company committed to developing transformational therapies to address significant medical needs. The company was co-founded by Jeff Reich, MD, and Gavril Pasternak, MD, PhD, and was spun out of Memorial Sloan Kettering Cancer Center (MSKCC). Sparian has five programs that address acute and chronic pain, opioid use disorder, acute opioid overdose, and stimulant use disorder. Sparian is the recipient of two NIH/ NIDA grants worth nearly $20 million. For more information, visit www.sparianbiosciences.com.

Annie Pasternak
Chief Operating Officer
Sparian Biosciences
contact@sparianbiosciences.com