Newleos Therapeutics Receives $15.5M Grant from NIH

Newleos Therapeutics, a Boston-based clinical-stage biotechnology company developing treatments for neuropsychiatric disorders, has received a $15.5 million grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH).

The five-year, milestone-based grant will support the development of NTX-2001, the company's experimental drug for cocaine use disorder (CUD). The funding will cover a Phase 1 drug-drug interaction study followed by a Phase 2 efficacy study.

What is Newleos Therapeutics?

Newleos Therapeutics develops treatments for neuropsychiatric disorders, including anxiety, substance use disorders and cognitive impairment.

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Its drug pipeline includes oral small-molecule therapies targeting several neurological mechanisms. The company licensed its pipeline from Roche and is working on treatments designed to address conditions where existing therapies have limitations.

One of its key candidates, NTX-2001, is a partial agonist of trace amine-associated receptor 1 (TAAR1). The company is developing it as a potential treatment for substance use disorders, including alcohol use disorder (AUD) and cocaine use disorder.

NTX-2001 is designed to act on the TAAR1 pathway, which is being studied for its role in regulating brain functions associated with substance use.

How Much Funding Has Newleos Therapeutics Received?

Newleos Therapeutics has received a $15.5 million federal grant from NIDA. This is the company's first federal grant.

The five-year award is linked to development milestones and will fund two planned clinical studies of NTX-2001 for cocaine use disorder.

Who Provided the Funding to Newleos Therapeutics?

The $15.5 million grant was awarded by the National Institute on Drug Abuse (NIDA), which is part of the National Institutes of Health.

The funding will support clinical development of NTX-2001 for cocaine use disorder.

Why the Funding Matters

The grant will help Newleos advance NTX-2001 through a Phase 1 drug-drug interaction study and a subsequent Phase 2 efficacy study.

The company said the award followed preclinical evidence supporting the drug's potential mechanism of action, along with safety and tolerability data from human studies.

Separately, the US Food and Drug Administration has granted Fast Track designation to NTX-2001 for alcohol use disorder. This designation is intended to support the development and review of treatments for serious conditions with unmet medical needs.

Who founded Newleos Therapeutics?

Newleos Therapeutics was founded in 2024 by Federico Bolognani. The company is headquartered in Boston, Massachusetts.

“Cocaine use disorder is a serious, growing public health crisis with no FDA-approved pharmacotherapies available today, and this NIDA award provides funding to advance NTX-2001 through Phase 2 studies,” said Federico Bolognani, M.D., Ph.D., Newleos’ Co-founder and Chief Medical Officer.

Market and Business Growth

Newleos is currently conducting a Phase 1b proof-of-concept study of NTX-2001 in the United States for alcohol use disorder.

The study is evaluating the drug's effects on alcohol consumption compared with a placebo. It is also assessing safety, tolerability and pharmacokinetics in people with AUD.

The company's pipeline includes drug candidates targeting GABAA-γ1, V1a, TAAR1 and GABAA-α5 mechanisms. These programmes are being developed for conditions such as general anxiety, social anxiety, substance use disorders and cognitive impairment.

What Happens Next?

Newleos plans to use the grant to advance NTX-2001 through clinical studies for cocaine use disorder. The company will also continue its ongoing Phase 1b study for alcohol use disorder.

The FDA's Fast Track designation will support the drug's development for AUD, while the NIDA grant will fund its next clinical development stages for CUD.

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