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

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. "Clearance of the IND for TMP-301 brings us one step closer to our goal of developing medicines with the potential to benefit patients with alcohol and other substance use disorders," said Dr. Praveena Kandula, President of Tempero Bio, Inc. "Based on the robust preclinical data in animal models, we eagerly anticipate evaluating TMP-301 in patients with alcohol and other substance use disorders. This decision from the FDA is a critical achievement, and our team is committed to translating this mechanism into treatments that will help revitalize lives."

The TMP-301 program was awarded a grant expected to total $5.3 million over two years from NIDA to support Phase I development, with TMP-301's lead indication of treatment of cocaine use disorder. The grant was issued as part of the Grand Opportunity in Medications Development for Substance-Use Disorders (U01), a cooperative agreement providing financial assistance and significant scientific support from the NIH to selected clinical programs. Phase I studies of TMP-301 are expected to begin in Q1 2023. "Securing funding and scientific support from the NIH and NIDA to advance our mGlu5R NAM program is a significant achievement and reflects the need for new therapies for those afflicted," said Dr. Bruce Imbert, Chief Medical Officer of Tempero Bio, Inc.

Glutamate is an abundant excitatory neurotransmitter in the human CNS, with alterations in signaling being associated with alcohol and other substance use disorders. TMP-301 is a potent, selective, and orally available mGluR5 NAM designed to reduce excessive glutamate signaling. Tempero Bio plans to initiate a Phase I trial in the first quarter of 2023 in healthy volunteers.

Tempero Bio is a clinical-stage biopharmaceutical company developing treatments for substance use disorders and related conditions. Addiction is a chronic, relapsing brain disorder that can be treated, but for which limited therapeutic options exist. Tempero Bio is committed to bringing innovative medicines forward that change the course of treatment in substance use disorders and related conditions. Tempero Bio is an Aditum Bio portfolio company. For more information, please visit www.temperobio.com.

Aditum Bio is committed to improving public health by accelerating R&D in disease areas with both large and more targeted patient populations, where medical innovation can have a huge impact. Aditum Bio focuses on basic mechanisms of disease, in-licenses promising drug candidates directed at such pathophysiology's, and spins-out individual companies dedicated to bringing each candidate through Phase II clinical trials. Aditum Bio uses data, software and technology to help bring innovative medicines through the clinical trial phase more quickly and with lower costs than traditional pharmaceutical companies. For more information, please visit www.aditumbio.com.

The research and development activities will be supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number U01DA057118. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. 

SOURCE Tempero Bio