Patent protects CU-00048 into 2042 as T-type calcium channel antagonists near their first FDA decision in Essential Tremor
SAN CARLOS, Calif., Oct. 26, 2026 /PRNewswire/ -- Acurex Biosciences Corporation today announced the issuance of U.S. Patent No. 12,760,017, its first composition-of-matter patent covering CU-00048, an oral, brain-penetrant T-type calcium channel antagonist in late-preclinical development for Essential Tremor. The patent, issued October 13, 2026, provides protection into 2042, before any patent term extension.
T-type CaV3.1 calcium channels are now a clinically validated target in Essential Tremor, a condition affecting about seven million Americans. Praxis Precision Medicines' ulixacaltamide met primary endpoints of two pivotal Phase 3 studies and is under FDA review with a January 29, 2027 target action date. CU-00048 is designed to address the years of treatment that Essential Tremor requires:
- Designed for once-daily dosing. CU-00048 showed low clearance and high oral bioavailability in preclinical studies, a profile intended to keep brain levels steady without a modified-release formulation or the high peaks linked to side effects.
- State-dependent block. CU-00048 is 9.4-fold more potent against CaV3.1 channels in the inactivated state typical of overactive neurons. This is intended to dampen tremor-driving activity while limiting effects on normal signaling.
- Tremor reduction at low doses. CU-00048 significantly reduced tremor at 1 and 3 mg/kg in the mouse harmaline model of Essential Tremor. Tested head-to-head at 1 mg/kg, ulixacaltamide and suvecaltamide did not significantly reduce tremor, a difference Acurex attributes to CU-00048's higher brain exposure.
- A translational biomarker. In rats, CU-00048 reduced non-REM sleep sigma-band EEG power in step with brain drug levels, the same signal Praxis used to guide ulixacaltamide dosing in healthy volunteers. Acurex plans to use this EEG signal in Phase 1 to measure target engagement.
"Ulixacaltamide's Phase 3 results showed this mechanism works, so the question now is which molecule delivers that benefit with the best tolerability and simplest dosing," said Bill Shrader, Ph.D., co-founder and Chief Scientific Officer of Acurex. "We designed CU-00048 to be that molecule. We anticipate that Phase 1 will tell us quickly whether the design holds up in people."
"With this patent, CU-00048 offers many of the elements that partners look for in a CNS program: a mechanism validated in Phase 3, a differentiated molecule protected into 2042, and a fast objective path to human target engagement data," said Lev Leytes, co-founder and Chief Executive Officer of Acurex. "We are in discussions with potential partners and investors about advancing CU-00048 into the clinic."
About Acurex Biosciences
Acurex Biosciences Corporation is a privately held biotechnology company in San Carlos, California, developing small-molecule therapies for neurological diseases.
Forward-Looking Statements
This release contains forward-looking statements, including statements about CU-00048's potential efficacy, safety, tolerability, development, patent protection, and partnering. CU-00048 has not been tested in humans, and preclinical results may not predict clinical outcomes. Actual results may differ materially.
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SOURCE Acurex Biosciences Corporation
