Tempero Bio – a clinical-stage biopharmaceutical company developing transformative treatments for substance use disorders – announced the closing of a $70 million Series B financing. The funding was led by 8VC with participation from Aditum Bio, Khosla Ventures, and other investors.
These proceeds will be used to advance TMP-301 through two Phase 2 clinical trials for alcohol use disorder and cocaine use disorder and Phase 3-enabling activities and preclinical studies for additional indications and formulations.
TMP-301 is a next-generation metabotropic glutamate receptor 5 (mGluR5) negative allosteric modulator (NAM) designed to address the neurobiological basis of addiction. It has shown promising results in preclinical models of alcohol, cocaine, and opiate use disorders.
TMP-301 was evaluated in over 80 healthy volunteers in the Phase 1 setting, with an acceptable safety and tolerability profile. It has also demonstrated robust receptor occupancy via positron emission tomography (PET) imaging.
Tempero Bio has initiated two clinical studies to support TMP-301’s development:
— A Phase 2 trial evaluating TMP-301’s efficacy and safety in patients with alcohol use disorder.
— A drug-drug interaction (DDI) study assessing TMP-301 in individuals using cocaine. The National Institute on Drug Abuse of the National Institutes of Health supported the research under Award Number U01DA057118.
— A Phase 2 study in cocaine use disorder is planned following the completion of the DDI study.
The addiction crisis remains a significant public health challenge. The 2023 National Survey on Drug Use and Health reported that:
— 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 numbers, nearly 13 million people sought treatment in 2023, reflecting a strong demand for better therapeutic options. And the goal is to provide better treatments for these patients.
KEY QUOTE:
“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. 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.”
– Ricardo Dolmetsch, Ph.D., President and Chief Scientific Officer of Tempero Bio