Tempero Bio has raised $70m in Series B financing to advance its lead candidate TMP-301 through two clinical trials for alcohol use disorder (AUD) and cocaine use disorder (CUD).

8VC led the Series B round, with participation from Aditum Bio, Khosla Ventures, and other investors. The capital will support Phase III-enabling activities, preclinical studies for additional indications, and new formulations of TMP-301, as per the 24 March announcement.

TMP-301 is a metabotropic glutamate receptor 5 (mGluR5)-negative allosteric modulator (NAM), which plays a role in central nervous system function. Tempero said that the candidate can prevent relapse by “targeting the underlying biology of addiction”.

US-based Tempero has kicked off two clinical studies to support TMP-301’s development. This includes a Phase II trial evaluating TMP-301’s safety and efficacy in patients with AUD (NCT06648655), and a drug-drug interaction (DDI) study (NCT06648668) assessing the mGluR5-targeting candidate in individuals using cocaine. A full Phase II study in CUD is planned once the DDI study concludes.

TMP-301 has shown promise in preclinical models of alcohol, cocaine, and opioid use disorder (OUD), and demonstrated safety and tolerability in Phase I studies involving over 80 healthy volunteers.

Tempero was launched in 2020 by Aditum Bio, the investment firm founded by former Novartis executives Joe Jimenez and Mark Fishman, in partnership with pharmaceutical company Sosei Heptares. Sosei licenced TMP-301 to Tempero in return for an upfront payment and strategic equity stake in Tempero.

Despite the public health burden of alcohol use disorder and cocaine use disorder, treatment options remain limited. Only three US Food and Drug Administration (FDA)-approved medications exist for alcohol use disorder, Antabuse (disulfiram), Revia/Vivitrol (naltrexone), and Campral (acamprosate). However, research from the US non-profit, the Federation of American Scientists (FAS), indicates they are only prescribed to around 2% of persons with AUD in the US.

In the announcement accompanying the funding, Ricardo Dolmetsch, chief scientific officer of Tempero Bio said: “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.”

Beyond mGluR5 modulation, several other approaches are emerging. Glucagon- like receptor 1 agonists (GLP-1RAs), currently used for diabetes and weight loss, are being investigated for their potential to curb alcohol use and opioid addiction, signalling a shift in how substance use disorders may be treated in the future.

mGluR5 modulation is also being explored in other indications. In January 2024, Switzerland-based Stalica raised $17.5m in Series B financing to fund clinical trials for its mGluR5-targeting candidate mavoglurant. Stalica signed an in-licencing agreement with Novartis to develop the drug as a treatment for substance use disorders and neurodevelopmental disorders (NDDs) in January 2023. The company is planning a Phase III trial for mavoglurant in patients with cocaine use disorder later in 2025.