Sparian Biosciences has initiated a Phase I clinical trial of SBS-147, a next-generation arylepoxamide receptor (AEAr) agonist being developed as an oral treatment for both acute and chronic pain.

The early-stage trial will evaluate the safety, tolerability and pharmacokinetics of SBS-147 in healthy volunteers through a combined single ascending dose (SAD) and multiple ascending dose (MAD) design. The study marks the company’s return to clinical development following encouraging preclinical results.

SBS-147 builds on Sparian’s first-generation AEAr agonist, SBS-1000, which has already completed a Phase I single ascending dose study as an injectable therapy for acute pain. Unlike its predecessor, SBS-147 is designed for oral administration, offering greater flexibility and expanding its potential use across a wider range of pain indications.

Preclinical studies have shown that SBS-147 delivers potent and durable pain relief in both nociceptive and neuropathic pain models, with effects lasting up to 24 hours. Importantly, the compound demonstrated a differentiated safety profile, with no evidence of respiratory depression or abuse potential typically associated with opioids such as Morphine.

The development programme for SBS-147, spanning Phase I through Phase II trials, is supported by a USD 15 million grant under the HEAL (Helping to End Addiction Long-term) Initiative led by the National Institute on Drug Abuse, part of the National Institutes of Health. The initiative was established to accelerate the development of treatments addressing opioid addiction and related disorders.

Sparian Biosciences, co-founded by Jeffrey B. Reich and Gavril Pasternak and spun out of Memorial Sloan Kettering Cancer Center, has received nearly USD 75 million in government funding across multiple programmes. Its pipeline targets a range of conditions, including acute and chronic pain, opioid use disorder, withdrawal syndrome, overdose and stimulant use disorder.

The company said SBS-147 could represent a significant step toward reducing reliance on opioids in pain management, addressing a critical unmet need amid the ongoing global opioid crisis.