Sparian Biosciences Announces Initiation of Phase 1 Clinical Trial of First-In-Class Arylepoxamide Agonist, SBS-1000, for the Treatment of Pain 

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• SBS-1000 is the first arylepoxamide agonist for the treatment of pain to receive IND clearance

• Phase 1 clinical trial will evaluate the safety, tolerability, pharmacokinetics, and analgesic efficacy of SBS-1000 

• SBS-1000 may present an alternative to opioids for the treatment of pain

 

NEW YORK, NY,  February 23, 2023 -- Sparian Biosciences, Inc., a clinical-stage CNS-focused biopharmaceutical company, today announced the initiation of a phase 1 clinical trial of SBS-1000, its first-in-class arylepoxamide receptor (AEAr) agonist. SBS-1000 is the first AEAr agonist to receive IND clearance from the FDA and to proceed to a phase 1 human clinical study.
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 addition, in preclinical safety studies, SBS-1000 does not demonstrate respiratory depression, physical dependence, or abuse liability compared to morphine. 
“Effective pain management remains a significant challenge across medical and surgical conditions, and SBS-1000 has the potential to replace opioids for the treatment of acute and chronic pain. In the face of the ongoing opiate crisis, we believe SBS-1000 could represent a fundamental and critically needed innovation,” said Jeffrey B. Reich, MD, Chief Executive Officer, Sparian Biosciences. “We have been eager to start the  phase 1 trial and hope that the promising preclinical profile of SBS-1000 will translate to human studies.”

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.

About Sparian Biosciences
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. 

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

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• 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

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NEW YORK, NY,  February 9, 2023 -- 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.

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About Sparian Biosciences

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.