Tempero Bio, a clinical-stage biotech firm tackling the growing substance use disorder crisis, has secured $70 million in Series B funding. This fresh capital injection, led by 8VC with support from Aditum Bio, Khosla Ventures, and other investors, will fuel the clinical development of its lead candidate, TMP-301. The company plans to conduct two critical Phase 2 trials targeting alcohol and cocaine use disorders—two areas of urgent unmet need.
With millions struggling with addiction nationwide, Tempero Bio aims to fast-track TMP-301 through proof-of-concept studies and preclinical work that could pave the way for broader applications and new formulations. Phase 3-enabling activities are also on the horizon as the company doubles down on its mission to combat addiction at the neurobiological level.
“Substance use disorders devastate millions of families across the U.S., contributing to over 100,000 deaths every year. We desperately need better treatment options,” said Ricardo Dolmetsch, Ph.D., President and Chief Scientific Officer of Tempero Bio. “TMP-301 represents a new class of therapy designed to address the root causes of addiction and prevent relapse. Thanks to this funding, we can advance our Phase 2 trials and move closer to delivering hope for patients and their loved ones.”
A New Approach to Treating Addiction
TMP-301 is a next-generation metabotropic glutamate receptor 5 (mGluR5) negative allosteric modulator (NAM). This novel compound directly targets the neural pathways involved in addictive behavior. In preclinical studies, TMP-301 demonstrated promising potential across multiple substance use disorders—including alcohol, cocaine, and opioids.
The drug has already passed initial safety testing in over 80 healthy volunteers during Phase 1 trials. Results showed an acceptable safety and tolerability profile, with strong evidence of brain receptor engagement confirmed through PET imaging. These encouraging findings set the stage for advancing into more extensive clinical trials.
Advancing Clinical Trials for Alcohol and Cocaine Use Disorders
Tempero Bio has now launched a Phase 2 trial focusing on patients with alcohol use disorder (AUD), evaluating both the safety and effectiveness of TMP-301. A separate drug-drug interaction (DDI) study is underway, exploring TMP-301’s impact on individuals actively using cocaine.
The cocaine study receives partial funding support from the National Institute on Drug Abuse (NIDA) under the National Institutes of Health (NIH) grant U01DA057118. Once the DDI study wraps up, the company plans to initiate a dedicated Phase 2 trial for cocaine use disorder.
Growing Demand for New Addiction Treatments
The addiction crisis continues to escalate, making effective treatment options more urgent than ever. Data from the 2023 National Survey on Drug Use and Health reveals the staggering scope of the problem:
- 28 million Americans battle alcohol use disorder
- 29 million suffer from drug use disorders, with 7 million meeting the criteria for both alcohol and drug issues
- 1.3 million Americans struggle with cocaine use disorder—a condition with zero FDA-approved treatments
Despite the growing demand for care, just under 13 million individuals sought treatment last year. This gap underscores the pressing need for innovative therapies like TMP-301 that address the root causes of addiction and offer hope for lasting recovery.
Leadership Expansion: John Wagner, M.D., Ph.D. Joins as Chief Medical Officer
Strengthening its leadership team, Tempero Bio has welcomed Dr. John Wagner as Chief Medical Officer. Dr. Wagner brings over two decades of clinical drug development expertise, having overseen more than 150 first-in-human trials. His track record includes pivotal roles in the approval of several blockbuster drugs.
Before joining Tempero Bio, Dr. Wagner held senior executive positions at Koneksa Health, Cygnal Therapeutics, Takeda, and Merck. He also served as a venture partner at Foresite Capital. In addition to his new role, Dr. Wagner remains Editor-in-Chief of Clinical and Translational Science and serves on the executive committee of the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium.
With this new funding round and strengthened leadership, Tempero Bio is well-positioned to push TMP-301 through the next critical stages of development. The company remains focused on delivering transformative therapies that can address the nation’s escalating addiction crisis.
