Tempero raises $70m for addiction treatment development

Tempero Bio, a biopharmaceutical company based in the United States, has successfully raised $70 million in Series B financing to accelerate the development of its leading drug candidate, TMP-301. This funding round was spearheaded by the venture firm 8VC, with additional investments from Aditum Bio, Khosla Ventures, and other stakeholders. The substantial capital influx is intended to support pivotal Phase III-enabling activities, conduct preclinical studies for additional uses, and develop new formulations of TMP-301.

TMP-301 is designed as a metabotropic glutamate receptor 5 (mGluR5) negative allosteric modulator (NAM), which plays a crucial role in the functioning of the central nervous system. According to Tempero, TMP-301 holds significant potential in preventing relapse by addressing the fundamental biology underlying addiction. The therapeutic focus is on alcohol use disorder (AUD) and cocaine use disorder (CUD), areas in dire need of effective treatment options.

Tempero Bio has initiated two clinical trials to advance TMP-301's development. The first is a Phase II trial, which aims to assess the safety and efficacy of TMP-301 in patients suffering from AUD. The second is a drug-drug interaction (DDI) study focused on individuals using cocaine, assessing how TMP-301 interacts with other substances. A comprehensive Phase II study for TMP-301 targeting CUD is anticipated to launch following the completion of the DDI study.

Preclinical models have shown TMP-301 to be promising in addressing alcohol, cocaine, and opioid use disorders (OUD). Additionally, Phase I studies involving over 80 healthy volunteers have demonstrated the drug's safety and tolerability.

Tempero Bio was established in 2020 through a collaboration between Aditum Bio—a firm founded by former Novartis executives Joe Jimenez and Mark Fishman—and the pharmaceutical company Sosei Heptares. Sosei Heptares licensed TMP-301 to Tempero in exchange for an upfront payment and a strategic equity stake in the company.

The public health challenges posed by alcohol and cocaine use disorders are significant, yet treatment options remain scarce. In the United States, there are only three approved medications for AUD: Antabuse (disulfiram), Revia/Vivitrol (naltrexone), and Campral (acamprosate). Despite these available treatments, research from the Federation of American Scientists (FAS) suggests that only about 2% of individuals with AUD in the U.S. receive these medications.

In a statement accompanying the funding announcement, Ricardo Dolmetsch, Chief Scientific Officer of Tempero Bio, highlighted the urgent need for more effective treatments. He noted that substance use disorders affect 48 million Americans and are linked to over 100,000 deaths annually, underscoring the critical demand for innovative solutions to support patients and their families.

Beyond the modulation of mGluR5, other therapeutic approaches are also being investigated. Glucagon-like receptor 1 agonists (GLP-1RAs), traditionally used for managing diabetes and facilitating weight loss, are under examination for their potential in reducing alcohol use and treating opioid addiction. This signals a broader shift in the approaches to treating substance use disorders in the future.

Moreover, mGluR5 modulation is being explored for other health conditions. A Swiss company, Stalica, secured $17.5 million in Series B financing in early 2024 to further clinical trials for its mGluR5-targeting drug, mavoglurant. Stalica has entered into an in-licensure agreement with Novartis to develop mavoglurant for treating substance use disorders and neurodevelopmental disorders. The company is planning a Phase III trial focusing on mavoglurant in patients with cocaine use disorder, expected to commence in 2025.