Tempero Bio Raises $70M for Phase 2 Trials of TMP-301 in Substance Use Disorders

Tempero Bio, Inc., a biopharmaceutical company focused on developing innovative treatments for substance use disorders, recently secured $70 million in Series B financing. The funding round was led by 8VC, with contributions from Aditum Bio, Khosla Ventures, and other investors. The infusion of capital will support the advancement of TMP-301, a treatment targeting alcohol and cocaine use disorders, through Phase 2 clinical trials. Additionally, the funds will facilitate Phase 3 preparation and further preclinical studies for new indications and formulations.

The prevalence of substance use disorders in the United States is staggering, impacting 48 million Americans and resulting in over 100,000 deaths annually. Tempero Bio aims to address this crisis with TMP-301, a novel therapy designed to prevent relapse by targeting the biological underpinnings of addiction. Ricardo Dolmetsch, Ph.D., President and Chief Scientific Officer of Tempero Bio, emphasized the critical need for effective treatments, highlighting TMP-301's potential to make a significant impact.

TMP-301 is a cutting-edge metabotropic glutamate receptor 5 (mGluR5) negative allosteric modulator (NAM) aimed at addressing the neurobiological aspects of addiction. It has shown promising outcomes in preclinical models for alcohol, cocaine, and opiate use disorders. In Phase 1 trials involving over 80 healthy volunteers, TMP-301 demonstrated an acceptable safety and tolerability profile, with robust receptor occupancy confirmed via positron emission tomography (PET) imaging.

Tempero Bio has initiated clinical studies to further TMP-301's development. These include a Phase 2 trial assessing the drug's efficacy and safety in patients with alcohol use disorder and a drug-drug interaction (DDI) study examining its effects in individuals using cocaine. The National Institute on Drug Abuse of the National Institutes of Health has supported the drug-drug interaction study under Award Number U01DA057118. A Phase 2 study for cocaine use disorder is planned after the DDI study concludes.

The addiction crisis remains a significant public health challenge. According to the 2023 National Survey on Drug Use and Health, 28 million Americans are affected by alcohol use disorder, and 29 million suffer from drug use disorders. Of these, 1.3 million Americans have cocaine use disorder, with no existing FDA-approved medications. Although nearly 13 million people sought treatment in 2023, the demand for better therapeutic options continues to grow. Tempero Bio is committed to providing improved treatments to meet this demand.

The company also welcomed Dr. John Wagner as Chief Medical Officer. With over 20 years of experience in drug development, Dr. Wagner has successfully led more than 150 first-in-human clinical trials and contributed to the market introduction of multiple blockbuster therapies. His previous roles include Chief Medical Officer positions at Koneksa Health and Cygnal Therapeutics, senior leadership positions at Takeda and Merck, and a venture partner role at Foresite Capital. Dr. Wagner also 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.

Tempero Bio is dedicated to developing transformative therapies for substance use disorders, chronic brain diseases with limited pharmacological solutions. As an Aditum Bio portfolio company, it aims to redefine treatment paradigms through science-driven therapies, ultimately improving the lives of those affected by addiction.