Sone-214

The Phase IIa data validated target engagement and informed the dose selection for the ongoing Phase IIb/III trial.

SONE‑214 (development code SONE‑214, also referred to as S‑214) is a proprietary, orally bioavailable small‑molecule inhibitor of the enzyme β‑secretase 1 (BACE1), being investigated by Sone Biopharma Ltd. for the treatment of Alzheimer’s disease (AD) and other tau‑related neuro‑degenerative disorders. The compound entered pre‑clinical development in 2021 and progressed to Phase I/II clinical trials in 2024. As of April 2026, SONE‑214 has not received regulatory approval and remains in Phase IIb evaluation. SONE-214

| Parameter | Value (healthy volunteers) | |-----------|-----------------------------| | Oral bioavailability | 68 % (fasted) | | C_max | 2.1 µM (after 50 mg dose) | | T_max | 2.5 h | | Half‑life (t_1/2) | 12.4 h (dose‑linear up to 200 mg) | | Volume of distribution (V_d) | 2.2 L kg⁻¹ | | Plasma protein binding | 96 % (albumin) | | BBB penetration | Unbound brain/plasma ratio ≈ 0.8 | | Clearance (CL) | 0.48 L h⁻¹ kg⁻¹ (primarily hepatic via CYP3A4) | | Metabolites | Two minor oxidative metabolites (M1, M2) cleared renally; no active metabolites detected. | The Phase IIa data validated target engagement and

Pharmacodynamic markers (measured in cerebrospinal fluid, CSF) show a dose‑dependent reduction in Aβ₄₂ (up to 71 % at 100 mg BID) within 14 days of treatment. M2) cleared renally