Sparian Biosciences Awarded $19 Million Five-Year NIH/NIDA Grant to Fund Development of SBS-518 for Stimulant Use Disorder Through Phase 1 Clinical Development

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• SBS-518 is a dual sigma receptor antagonist/dopamine active transporter inhibitor in development for the treatment of stimulant use disorder (e.g., cocaine and methamphetamine)

• Grant awarded by National Institutes of Health / National Institute of Drug Abuse (NIH/NIDA) under the Help End Addiction Long-Term (HEAL) initiative

 

NEW YORK, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Sparian Biosciences, Inc.(“Sparian”), a clinical-stage CNS-focused biopharmaceutical company, today announced that it has been awarded a $19 million, five-year grant to fund development of SBS-518 from IND submission through Phase 1 clinical development. SBS-518 is a first-in-class dual sigma receptor (SR)antagonist/dopamine transporter (DAT) inhibitor in development for the treatment of stimulant use disorder (StUD). StUD is a subset of substance use disorders that includes cocaine and methamphetamine use disorders. The grant was awarded by NIH/NIDA under the Help End Addiction Long-Term (HEAL) initiative.
SBS-518 is a novel first-in-class compound that targets within the brain both the sigma receptor (S1 and S2) and the dopamine active transporter (DAT). In pre-clinical efficacy assays, SBS-518 blocks the stimulant induced rise in extra-cellular dopamine and blocks cocaine and methamphetamine self-administration without itself producing self-rewarding behavior. DAT, the site of action for stimulants, including illicit stimulants, has proven to be an elusive target for therapeutics. The combination of sigma and DAT inhibition appears to block the action of methamphetamine and cocaine without interfering with the physiologic transport of dopamine.

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“Sparian was founded to develop innovative therapeutics to treat CNS disorders, particularly pain and substance use disorders,” said Jeff Reich, M.D., Chief Executive Officer and Co-founder. “StUD presents a major unmet medical and public health need for which there are currently no approved therapies. If we can successfully advance SBS-518 into the clinic, it could represent a significant step forward in the treatment of substance use disorders.”
The $19 million dollars in funding represents the third NIH/NIDA grant Sparian has received. Since its founding, Sparian has been awarded a total of $41 million in government grants to support three programs. The lead program SBS1000, a non-opioid analgesic, is now in phase 1 clinical trials. SBS-226, a dual mu opioid receptor(MOR) agonist/delta opioid receptor (DOR) antagonist, is being developed for opioid use disorder (OUD).

“We are extremely proud of the ongoing support we have received from NIDA,” said Dr. Reich. “NIDA, through the HEAL initiative, has sparked a new wave of innovation and entrepreneurship dedicated to the treatment of substance use disorders. Sparian, along with our academic partners, is honored to be a trusted collaborator.”

SBS-518 is being developed in collaboration with the National Institute of Drug Abuse (NIDA), University of Florida College of Pharmacy, and the Harvard Medical School-McLean Hospital.

About Stimulant Use Disorder (StUD)

StUD represents a serious public health crisis in the U.S. with a growing prevalence of 4.1 million and approximately 57,000 annual deaths reported in 2021. There are no U.S. Food and Drug Administration-approved drugs to treat StUD. The current treatment approach includes off-label use of prescription therapies, such as antidepressants, and/or behavioral-psychosocial modalities. Only modest benefits have been demonstrated. It is estimated that only 13% of eligible patients are undergoing treatment of any kind reflecting the lack of effective medication.

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, M.D., and Gavril Pasternak, M.D., Ph.D., and was spun out of Memorial Sloan Kettering Cancer Center (MSK). Sparian has five programs that address acute and chronic pain, opioid use disorder (OUD),acute opioid overdose, and stimulant use disorder (StUD). Sparian is the recipient of two NIDA UG3/UH3 grants and an SBIR grant totaling nearly $41M in NIH support. For more information, visit www.Sparianbiosciences.com

 

Research reported in this press release was supported by the National Institute on Drug Abuse of the National Institutes of Health under award number1UG3DA058553-01.
The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health

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.