Sparian Biosciences Awarded $19.5 Million Five-Year NIH/ NIDA Grant to Fund Development of SBS-226 for Opiate Use Disorder/ Opiate Withdrawal Syndrome Through Phase 1 Clinical Development

• SBS-226 is a dual mu opiate receptor (MOR) partial agonist and delta opiate receptor (DOR) full antagonist in development for opiate use disorder (OUD) and Opiate Withdrawal Syndrome (OWS)
• 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 $19.5 million, five-year grant to fund development of SBS-226 from IND submission through Phase 1 clinical development. SBS-226 is a first-in-class dual mu opiate receptor (MOR) partial agonist and delta opiate receptor (DOR) full antagonist in development for opiate use disorder (OUD)/ Opiate Withdrawal Syndrome (OWS). The grant was awarded by NIH/NIDA under the Help End Addiction Long-Term (HEAL) initiative.

SBS-226 is a novel first-in-class compound that is both a partial agonist at the MOR and full antagonist at DOR. In pre-clinical efficacy models, SBS-226 is highly effective at reducing opiate induced withdrawal. Even in models in which acute opiate intoxication is reversed, SBS-226 will mitigate withdrawal symptoms. Unlike the current medications on the market for OUD, SBS-226 does not precipitate withdrawal in animals that have been chronically exposed to highly potent opioids.

“While Sparian was founded to develop innovative therapeutics to treat neurologic and neuropsychiatric conditions, we quickly focused our efforts in the areas of pain and substance use disorders,” said Jeff Reich, M.D., Chief Executive Officer and Co-founder. “Opiate Use Disorder still represents a huge unmet medical and public health need. Despite the crisis, there has been little innovation and new drug development to help patients control their addiction. We think SBS-226 has a chance to replace the current standard of care as a more effective and safer option particularly as it avoids the problem of precipitated withdrawal.”

The $19.5 million dollars in funding represents the third NIH/NIDA grant Sparian has received. Since its founding, Sparian has been awarded over $60 million in government grants to support four programs. The lead program SBS1000, a non-opioid analgesic, just completed phase 1 clinical trials. 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).

“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-226 is being developed in collaboration with Susruta Majumdar, PhD from Washington University, National Institute of Drug Abuse (NIDA), and Memorial Sloan Kettering Cancer Center.

About Opiate Use Disorder (OUD)

OUD represents a serious public health crisis in the U.S. with a growing prevalence of over 4 million and approximately 75,000 opiate related overdose annual deaths reported in 2023. While there are U.S. Food and Drug Administration-approved drugs to treat OUD, there have been many barriers and obstacles to wider and more effective adoption of these therapeutics. A new drug with a novel mechanism of action has a chance to transcend the stigma of the current standard of care, transform the treatment paradigm and pave the way to finally curbing this substance use epidemic.