FDA clears investigational new drug application for cocaine use treatment
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The FDA has given clearance to an investigational new drug application for TMP-301, a treatment for cocaine use disorders, according to the drug manufacturer.
The program has also been awarded a grant expected to total $5.3 million grant over the course of 2 years from the National Institute on Drug Abuse in support of the development of TMP-301, according to a press release from Tempero Bio.
“We're really excited to have NIDA as a partner to help support us on our mission to ... bring this new therapy into the clinic, and to really help develop therapies for underserved populations,” Praveena Kandula, MD, president of Tempero Bio, told Healio. “This funding helps validate both the need for this therapy as well as our approach to developing therapies in this space.”
TMP-301 is the company’s investigational metabotropic glutamate receptor 5 negative allosteric modulator candidate. Glutamate is an excitatory neurotransmitter in the central nervous system, with alterations in signaling that are associated with alcohol and substance use disorders, according to the release. The treatment is designed to reduce glutamate signaling.
“We formed Tempero Bio in response to what we were seeing with the global pandemic, when we saw addiction rates skyrocketing,” Kandula said. “We didn't see that this problem was going away anytime soon, and it was such a huge area of unmet need. We knew we had to think about building a company around delivering a new treatment for substance use disorders.”
Tempero Bio plans to initiate a phase 1 trial for TMP-301 in healthy volunteers during the first quarter of 2023.