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

• 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

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.

“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.