Tempest Therapeutics (TPST) Stock Jumps 83% on FDA Phase 3 Trial News

Tempest Therapeutics announced today that it secured an FDA agreement on the design and execution of its upcoming Phase 3 cancer drug trial.

Ryan Troup August 15, 2024Last Updated: August 15, 2024

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DNA stand floats in front of a rising Tempest Therapeutics stock chart. — Source: Shutterstock

Tempest Therapeutics (NASDAQ: TPST), a clinical-stage biotechnology firm focused on innovative cancer therapies, announced a significant milestone on Thursday as it secured the U.S. Food and Drug Administration’s (FDA) agreement on the design and execution of its upcoming Phase 3 trial for the experimental cancer drug amezalpat (TPST-1120). This news prompted an intra-day surge of as much as 83% in Tempest stock, reflecting investor optimism about the potential of this new treatment.

Amezalpat, an oral PPAR⍺ antagonist, is being developed as a first-line treatment for hepatocellular carcinoma (HCC), a form of liver cancer. The planned global Phase 3 trial is designed to evaluate the efficacy of amezalpat in combination with atezolizumab and bevacizumab—two existing cancer therapies—against the current standard of care. This trial will be a pivotal step in determining whether amezalpat can offer a significant survival advantage for patients with unresectable or metastatic HCC.

Promising Phase 2 Results Fuel Confidence

The design of the Phase 3 trial closely mirrors that of a preceding Phase 2 study, which produced promising results, particularly in terms of overall survival—a key metric in cancer treatment.

Tempest’s Chief Medical Officer and Head of Research & Development, Dr. Sam Whiting, expressed confidence in the upcoming trial, stating:

“The strongly favorable hazard ratio for overall survival observed at topline analysis of Phase 2, confirmed at the latest survival follow-up, gives us confidence in the potential success of Phase 3.”

The FDA’s feedback during the end-of-Phase 2 meeting was largely positive, with broad agreement on several critical aspects of the Phase 3 trial. These include the appropriateness of the current amezalpat dosage, the schedule for the trial, and the statistical plan that includes a pre-specified early efficacy analysis. This early analysis could significantly shorten the time to the primary analysis by up to eight months, potentially accelerating the availability of results that could influence treatment standards for HCC.

Innovative Mechanism and Strategic Approach

Amezalpat’s mechanism of action, targeting tumor cells directly while also modulating the tumor microenvironment, positions it as a potentially groundbreaking therapy. By inhibiting PPAR⍺, amezalpat aims to both suppress cancer cell growth and modulate the immune response within the tumor environment, offering a dual approach to fighting cancer.

The Phase 3 study, set to commence in the first quarter of 2025, will be a global, blinded, randomized trial involving patients with unresectable or metastatic HCC. Participants will be randomly assigned to receive either the combination of amezalpat with atezolizumab and bevacizumab or the current standard of care alone. This rigorous trial design, along with the early efficacy analysis, reflects Tempest Therapeutics’ commitment to advancing cancer treatment through innovative approaches.

A Cautious Optimism

While the FDA’s alignment with Tempest’s trial design is a significant step forward, the company remains cautious. Investors are reminded that forward-looking statements are not guarantees of future performance, and actual results may differ due to a variety of factors. Nonetheless, the strong foundation laid by the Phase 2 results and the strategic planning for Phase 3 offer a beacon of hope for advancements in treating liver cancer.

“We are thrilled with the positive outcome of our end-of-Phase 2 meeting with the FDA,” Dr. Whiting added. “This planned Phase 3 study closely mirrors the randomized Phase 2 study and the strongly favorable hazard ratio for overall survival observed at topline analysis of the Phase 2, confirmed at the latest survival follow-up, give us confidence in the potential success of the Phase 3.”

As Tempest Therapeutics prepares for this critical trial, the biotechnology world watches with interest, hopeful that amezalpat could become a new cornerstone in the treatment of hepatocellular carcinoma.

Shares of Tempest Therapeutics stock soared as much as 83% today topping out at an intra-day high of $2.18. Tempest Therapeutics stock closed the day at $1.55, up 30.25% today. YTD, TPST stock is down 64.85%. All time, TPST stock is down 99.91%.