Tokyo, Japan and Cambridge, UK, 25 March 2025 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) announces that its partner Tempero Bio, Inc. has initiated a Phase 2 trial of TMP-301, a potent, selective and orally available mGluR5 negative allosteric modulator (NAM), for the treatment of alcohol use disorder (Clinical Trial ID: NCT06648655). The full announcement from Tempero Bio can be found by clicking here, in which Tempero Bio also announces the close of a $70 million financing, the proceeds of which will be used to advance TMP-301 through the Phase 2 trial for alcohol use disorder and a second Phase 2 trial in cocaine use disorder planned to start over the next year. The funds will also be used by Tempero Bio to conduct Phase 3-enabling activities for TMP-301 and preclinical studies for additional indications and formulations.
The Phase 2 study initiated will assess the safety, tolerability and effect on alcohol use of TMP-301 compared to placebo in patients with alcohol use disorder.
Matt Barnes, EVP, President of Nxera Pharma UK and Head of R&D, commented: “We are excited to see another program originating from our NxWave™ discovery platform advancing into the next stage of clinical development, as our partner Tempero Bio progresses TMP-301 to a Phase 2 trial for alcohol use disorder. This asset is another example highlighting the strength of our NxWave™ platform to continue delivering innovative candidates for further development. We are expecting an important year ahead across both our partnered and inhouse pipelines, with key data readouts anticipated from multiple trials as well as several new trials due to start.”
Tempero Bio was created in 2020 by the venture firm Aditum Bio to advance the clinical development of a portfolio of potent, orally available metabotropic glutamate receptor 5 (mGluR5) NAMs, including TMP-301, discovered by Nxera and in development for substance use disorders.
Under the terms of the 2020 agreement, Tempero Bio acquired exclusive global rights to Nxera’s portfolio of mGluR5 NAM candidates. In return, Nxera received a strategic equity stake in Tempero Bio and is eligible to receive future success-based development and commercial milestone payments plus tiered royalties from any future product sales.
There is no milestone payment payable by Tempero Bio to Nxera associated with the start of the Phase 2 trial. Nxera will disclose if a milestone event is reached that results in a material payment from Tempero Bio to Nxera.
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About Nxera Pharma
Nxera Pharma is a technology powered biopharma company, in pursuit of new specialty medicines to improve the lives of patients with unmet needs in Japan and globally.
In addition to several products being commercialized in Japan, we are advancing an extensive pipeline of over 30 active programs from discovery through to late clinical stage internally and in partnership with leading pharma and biotech companies. This pipeline is focused on addressing major unmet needs in some of the fastest-growing areas of medicine across neurology, GI and immunology, metabolic disorders and rare diseases, and leverages the power of our unique and industry leading GPCR-targeted structure-based drug discovery NxWave™ platform to provide a sustainable source of best- or first-in-class candidates.
Nxera employs over 350 talented people at key locations in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland) and Seoul (South Korea) and is listed on the Tokyo Stock Exchange (ticker: 4565).
For more information, please visit www.nxera.life
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Forward-looking statements
This press release contains forward-looking statements, including statements about the discovery, development, and commercialization of products. Various risks may cause Nxera Pharma Group’s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in clinical development programs; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
