#United States #Oakland #Substance Use #Tempero Bio #TMP-301

Tempero Bio Secures $70 Million Series B Financing

Tempero Bio, a pioneering clinical-stage biopharmaceutical company focused on innovative treatments for substance use disorders, has recently completed a $70 million Series B financing round. This funding provides crucial resources to advance their lead candidate, TMP-301, through Phase 2 clinical trials for both alcohol use disorder (AUD) and cocaine use disorder (CUD).

Background on the Financing

This financing round was led by 8VC, with participation from notable partners such as Aditum Bio and Khosla Ventures. The financial support will primarily fund two critical Phase 2 clinical trials aimed at evaluating the efficacy and safety of TMP-301. Additionally, funds will be allocated for Phase 3 enabling activities, as well as preclinical studies exploring other potential indications and formulations for TMP-301.

The Urgent Need for Effective Treatments

With approximately 48 million Americans grappling with substance use disorders, the development of effective treatments is more crucial than ever. The impact of addiction is profound, contributing to over 100,000 deaths annually. Dr. Ricardo Dolmetsch, President and Chief Scientific Officer of Tempero Bio, emphasized the necessity for novel therapies that address the biological underpinnings of addiction: "TMP-301 is designed to focus on the root biological issues leading to addiction, which can help prevent relapse among patients. This financing will allow us to further develop this promising therapy through significant clinical studies."

Overview of TMP-301

TMP-301 is a next-generation metabotropic glutamate receptor 5 (mGluR5) negative allosteric modulator (NAM), specifically developed to intervene in the neurobiological aspects of addiction. Early research has demonstrated promising results in preclinical models for various substance use disorders, including those related to alcohol, cocaine, and opiates. Initial assessments involving over 80 healthy volunteers in Phase 1 trials have shown that TMP-301 possesses an acceptable safety profile while achieving robust receptor occupancy as confirmed by positron emission tomography (PET) imaging.

Details on Clinical Studies

Tempero Bio has begun two significant clinical studies to support TMP-301’s progression:
1. Phase 2 Trial for Alcohol Use Disorder: This trial evaluates the safety and efficacy of TMP-301 in patients diagnosed with alcohol use disorder.
2. Drug-Drug Interaction Study: This study is designed to assess how TMP-301 interacts with cocaine in individuals currently using the substance, with plans to initiate a Phase 2 study focusing on cocaine use disorder once the DDI study is completed. It’s noteworthy that research under this program has been supported by the National Institute on Drug Abuse from the National Institutes of Health.

The Addiction Crisis: A Public Health Challenge

The addiction crisis constitutes one of the most pressing public health challenges of our time. According to the 2023 National Survey on Drug Use and Health, around 28 million Americans face alcohol-related issues, while 29 million contend with drug addiction—7 million of whom meet the criteria for both disorders. The survey also revealed that 1.3 million Americans struggle specifically with cocaine addiction, notably without any FDA-approved medication options currently. In response, nearly 13 million individuals sought treatment in 2023, underscoring the urgent demand for improved therapeutic alternatives.

Leadership Changes at Tempero Bio

In a bid to further enhance its capabilities, Tempero Bio has appointed Dr. John Wagner as the new Chief Medical Officer. Dr. Wagner comes with over 20 years of extensive drug development experience and has successfully led more than 150 first-in-human clinical trials. His previous roles include serving as CMO at Koneksa Health and Cygnal Therapeutics and holding senior positions at major pharmaceutical companies such as Takeda and Merck. He is also recognized for his editorial role with Clinical and Translational Science and is actively involved with the Foundation for the National Institutes of Health Biomarkers Consortium.

About Tempero Bio and Aditum Bio

Tempero Bio remains dedicated to addressing the gaps in treatment for substance use disorders, developing therapies that may redefine the treatment landscape. The company is part of the Aditum Bio portfolio, an organization focused on accelerating the advancement of promising drug candidates through clinical trials. For those interested in learning more about Tempero Bio, additional information can be found at www.temperobio.com.

As the fight against addiction persists, Tempero Bio’s continuing advancements in drug development shine a light of hope in challenging times. With TMP-301 in development, the journey towards better treatment options is on the horizon.