Camino Pharma initiates Phase 1 study of SBP-9330 in development for the treatment of tobacco use disorder

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Aug 25, 2021, 08:15 ET

SAN DIEGO, Aug. 25, 2021 /PRNewswire/ -- Camino Pharma, LLC, a San Diego–based biotechnology company developing small molecules to treat central nervous system disorders, announced today that it has dosed the first cohort in a Phase 1 clinical trial of SBP-9330 in healthy subjects. SBP–9330 targets a neuronal signaling pathway underlying addictive behaviors and would be a first-in-class oral therapeutic to help people quit smoking.

The study is being funded by the National Institute on Drug Abuse (NIDA) at the National Institutes of Health (NIH) through a grant awarded to Sanford Burnham Prebys, Camino Pharma, LLC, and the Department of Psychiatry, University of California San Diego, School of Medicine.

"We are excited to initiate the first-in-human study of SBP-9330 and are grateful for the investment that NIDA has made in the treatment of tobacco use disorder," says Gonul Velicelebi, Ph.D., CEO and co-founder of Camino Pharma. "Smoking continues to be the leading cause of preventable death in the US. Nearly 70% of adult smokers try to quit smoking, but only succeed less than 30% of the time, and often relapse after quitting. It has been 15 years since the U.S. Food and Drug Administration (FDA) last approved a therapeutic for this indication. We hope to advance SBP-9330 rapidly toward a Phase 2a clinical proof-of-concept trial, and ultimately as a viable therapeutic option for smokers to quit for good."

The randomized, placebo-controlled, double-blind, single-ascending and multiple-ascending dose study is being conducted at a single site in the United States under an Investigational New Drug (IND) application recently allowed by the FDA and will enroll up to 80 healthy volunteers through multiple cohorts (https://clinicaltrials.gov/ct2/show/NCT04948827). The goal of the study is to determine the safety, tolerability and pharmacokinetic profile of SBP-9330 in humans and to determine a safe dose range for further clinical development for the treatment of tobacco use disorder.

As a novel selective positive allosteric modulator of the metabotropic glutamate receptor 2 (mGlu₂), SBP–9330 is designed to reduce levels of glutamate, a neurotransmitter linked to addiction and relapse behavior. Preclinical studies of SBP-9330, supported by a previous NIDA grant awarded to the same three institutions, demonstrated that the drug candidate reduces nicotine self-administration in animal models and is safe and well tolerated in preclinical safety and toxicology studies.

"In the future, we also hope to broaden the indication of SBP-9330 to other types of addiction, such as cocaine, opioid, or methamphetamine use disorders. This is supported by preclinical data in other models of substance use as well as the mechanism of action of SBP-9330," states Nicholas Cosford, Ph.D., professor and deputy director of the National Cancer Institute–designated Cancer Center at Sanford Burnham Prebys and co-founder of Camino Pharma.

"We are excited about collaborating in the development of SBP-9330 to treat tobacco use disorder. Each year in the United States, roughly half a million people die from tobacco-related diseases. It is critical to have more therapeutic options if we want to reduce the number of deaths and illnesses related to smoking," says Robert Anthenelli, M.D., UC San Diego professor of psychiatry and one of the co-principal investigators on the NIDA project.

About Camino Pharma, LLC

Camino Pharma is a San Diego–based start-up focused on discovering and developing safe and effective first-in-class drugs to treat patients suffering from (1) psychiatric disorders that are poorly addressed by current medications, including substance use and major depression; and (2) the most aggressive forms of cancer with currently limited treatment options. We target signaling proteins based on emerging biological concepts and discover novel mechanisms for modulating these targets with small molecule drugs. Our leadership team has proven expertise in the relevant target biology, as well as extensive experience in drug discovery and development. Our innovative technology platform allows for exploiting inadequately served targets that require a highly adaptive and specialized approach to drug discovery. We intend to find novel cures using our deep understanding in target biology combined with well-tailored, cutting-edge discovery technologies. Visit Camino Pharma at www.caminopharma.com.

SOURCE Camino Pharma, LLC