Tempero Bio Announces FDA Clearance of Investigational New Drug (IND) Application for TMP-301 for the Treatment of Alcohol and Other Substance Use Disorders

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Excerpt from the Press Release:

OAKLAND, Calif., Jan. 4, 2023 /PRNewswire/ —

• Tempero Bio has recently been awarded a grant expected to total $5.3 million over two years from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, to support Phase I clinical studies for the treatment of cocaine use disorder.
• Tempero Bio’s TMP-301 is being researched to treat alcohol and other substance use disorders through the use of its mGluR5 NAM that modulates glutamate signaling in the brain. Phase I study to begin Q1 2023.
• Alcohol and other substance use disorders affect over 40 million people in the US alone and have limited treatment options.

Tempero Bio, Inc, a clinical-stage biopharmaceutical company focused on developing transformative therapies for the treatment and prevention of alcohol and other substance use disorders, today announced the U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application for TMP-301. TMP-301 is the Company’s investigational metabotropic glutamate receptor 5 (mGluR5) negative allosteric modulator (NAM) candidate, poised for a lead indication in the treatment of cocaine use disorders (CUD). 

The addiction crisis has become deadlier than ever, as overdoses have rapidly increased and are now the leading cause of accidental death in the U.S. The 2020 National Survey on Drug Use and Health found that 1.3 million Americans aged 12 or older had a CUD in the past year. Despite this, there are currently no approved medications for the treatment of CUD.

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