Nxera Pharma and Tempero Bio Initiate Phase 2 Trial for Alcohol Use Disorder Treatment
Tokyo, Japan and Cambridge, UK – Nxera Pharma Co., Ltd. (Nxera) and its partner Tempero Bio, Inc. are taking significant strides in the development of a new treatment for alcohol use disorder. Nxera, a Japanese pharmaceutical company listed on the Tokyo Stock Exchange (TSE 4565), and Tempero Bio, a US-based clinical-stage biotechnology company, have announced the initiation of a Phase 2 clinical trial for TMP-301, a potent, selective, and orally available mGluR5 negative allosteric modulator (NAM).
About TMP-301
TMP-301 is an innovative drug candidate designed to modulate the activity of metabotropic glutamate receptor 5 (mGluR5). This receptor plays a crucial role in the regulation of synaptic plasticity, learning, and memory. In the context of alcohol use disorder, excessive activation of mGluR5 contributes to the development and maintenance of addiction. TMP-301’s ability to selectively inhibit mGluR5 could potentially reduce the craving and relapse associated with alcohol use disorder.
Clinical Trial and Financing
The Phase 2 trial, which is taking place at multiple sites in the US, is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of TMP-301 in treating alcohol use disorder. Tempero Bio has also announced the close of a $70 million financing round, the proceeds of which will be used to advance TMP-301 through this Phase 2 trial and a second Phase 2 trial in cocaine use disorder planned to start over the next year. Additionally, the funds will be allocated to conduct Phase 3-enabling activities for TMP-301 and preclinical studies for additional indications and formulations.
Implications for Individuals and Society
For individuals struggling with alcohol use disorder, this development represents a potential new treatment option. Alcohol use disorder affects millions of people worldwide, and current treatment methods, such as behavioral therapies and 12-step programs, have varying degrees of success. If TMP-301 proves effective in clinical trials, it could offer a more targeted and potentially more successful approach to treating this condition.
From a societal perspective, the successful development and approval of TMP-301 could lead to significant cost savings. Alcohol use disorder imposes a substantial economic burden on society, with costs related to healthcare, lost productivity, and criminal justice involvement. A more effective treatment could help reduce these costs and improve overall societal well-being.
Conclusion
The initiation of a Phase 2 clinical trial for TMP-301, a potent, selective, and orally available mGluR5 negative allosteric modulator, by Nxera Pharma and its partner Tempero Bio is an exciting development in the field of alcohol use disorder treatment. With the support of a $70 million financing round, the companies aim to advance TMP-301 through clinical trials and explore its potential in additional indications and formulations. The successful development of this drug could offer a new, more targeted treatment option for individuals with alcohol use disorder, ultimately leading to improved outcomes for patients and significant cost savings for society.
- Nxera Pharma and Tempero Bio initiate Phase 2 trial for TMP-301, an mGluR5 NAM for alcohol use disorder
- $70 million financing to support clinical trials and preclinical studies
- Potential for new, targeted treatment option for alcohol use disorder
- Significant societal cost savings if successful
