Tempero Bio announced today it has secured $70 million in Series B financing to advance its lead candidate TMP-301 through Phase 2 clinical trials for substance use disorders. The funding round was led by 8VC with participation from Aditum Bio, Khosla Ventures, and other investors.
The Oakland, California-based clinical-stage biopharmaceutical company will use the proceeds to support two Phase 2 trials evaluating TMP-301 in alcohol use disorder and cocaine use disorder, as well as to fund Phase 3-enabling activities and preclinical studies for additional indications and formulations.
"Substance use disorders affect 48 million Americans and contribute to more than 100,000 deaths per year. We urgently need more effective treatments to help patients and families with these diseases," said Ricardo Dolmetsch, Ph.D., President and Chief Scientific Officer of Tempero Bio. "TMP-301 is a novel therapy that helps prevent relapse by targeting the underlying biology of addiction. This financing will allow us to advance TMP-301 through key proof of concept phase 2 studies in humans."
Novel Mechanism Targeting Addiction Biology
TMP-301 is a next-generation metabotropic glutamate receptor 5 (mGluR5) negative allosteric modulator (NAM) designed to address the neurobiological basis of addiction. The compound modulates glutamate signaling in the brain, a pathway with potential applications in treating various substance use disorders.
The drug candidate has demonstrated promising results in preclinical models of alcohol, cocaine, and opiate use disorders. Phase 1 studies have evaluated TMP-301 in over 80 healthy volunteers, showing an acceptable safety and tolerability profile along with robust receptor occupancy as demonstrated through positron emission tomography (PET) imaging.
Clinical Development Progress
Tempero Bio has already initiated a Phase 2 trial evaluating TMP-301's efficacy and safety in patients with alcohol use disorder. Additionally, the company is conducting a drug-drug interaction (DDI) study assessing TMP-301 in individuals using cocaine, supported by the National Institute on Drug Abuse under Award Number U01DA057118.
Following completion of the DDI study, Tempero plans to initiate a Phase 2 study in cocaine use disorder, addressing a condition for which there are currently no FDA-approved medications.
Addressing a Significant Public Health Challenge
The addiction crisis represents one of the most pressing public health challenges in the United States. According to the 2023 National Survey on Drug Use and Health:
- 28 million Americans suffer from alcohol use disorder
- 29 million Americans have a drug use disorder, with 7 million meeting criteria for both
- 1.3 million Americans have cocaine use disorder, with no FDA-approved medications available
Despite these staggering numbers, nearly 13 million people sought treatment in 2023, reflecting strong demand for better therapeutic options.
Leadership Expansion
As part of its growth strategy, Tempero Bio announced that Dr. John Wagner will join the company as Chief Medical Officer. Dr. Wagner brings more than 20 years of drug development experience, having successfully led over 150 first-in-human clinical trials and played pivotal roles in bringing multiple blockbuster therapies to market.
Prior to joining Tempero Bio, Dr. Wagner served as Chief Medical Officer at Koneksa Health and Cygnal Therapeutics, held senior leadership positions at Takeda and Merck, and was a venture partner at Foresite Capital. He currently serves as Editor-in-Chief of Clinical and Translational Science and holds an executive committee position with the Foundation for the National Institutes of Health Biomarkers Consortium.
Company Background
Tempero Bio was formed in 2020 through a partnership between Aditum Bio and Sosei Heptares (now known as Nxera). Aditum Bio, an investment firm run by former Novartis CEO Joe Jimenez and former head of Novartis Biomedical Research Mark Fishman, provided funding for Tempero, while Sosei licensed a suite of mGlu5 NAM modulator molecules, including TMP-301.
The company received investigational new drug (IND) clearance for TMP-301 in early 2023, along with a $5.3 million grant from the National Institutes of Health to study the compound in cocaine use disorders.
Tempero Bio is dedicated to developing innovative treatments for substance use disorders, which it describes as "chronic, relapsing brain diseases with limited pharmacologic solutions." The company aims to advance science-driven therapies that redefine treatment paradigms for addiction.
