SHENZHEN, China, 16 September 2026 — Artivila Biopharma, a clinical-stage AI‑driven drug discovery and development biotechnology company, today announced that the first healthy volunteer has been dosed in a Phase 1 clinical trial of ARD‑489AD. The study is a randomized, double‑blind, placebo‑controlled, single‑ and multiple‑ascending‑dose study to evaluate the safety, tolerability and pharmacokinetic profile of ARD‑489AD in healthy subjects in China. ARD‑489AD received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) in May 2026 and from China 's National Medical Products Administration (NMPA) in June 2026, respectively, for the treatment of chemotherapy‑induced peripheral neuropathy (CIPN). This Phase I trial will provide key data to support dose selection and indication positioning for subsequent Phase II clinical studies.

About ARD‑489AD

ARD‑489AD is a highly selective, brain-penetrating small‑molecule inhibitor of SARM1 (sterile alpha and TIR motif-containing 1), a neuronal NAD⁺ hydrolase that serves as a central driver of axonal degeneration. SARM1 is activated upon nerve fiber injury and depletes NAD⁺, triggering the destruction of axonal structures and, ultimately, neuronal cell death. This pathway is implicated in multiple neurological disorders, such as CIPN and amyotrophic lateral sclerosis (ALS). Preclinical data show that ARD-489AD demonstrates favorable neuroprotective effects and effectively inhibits neuroinflammatory responses in multiple animal disease models.

About Chemotherapy‑Induced Peripheral Neuropathy (CIPN)

CIPN is a common and debilitating dose‑limiting toxicity caused by chemotherapeutic agents. Over 60% of patients experience some degree of CIPN within the first month of treatment, and 30‑40% progress to chronic neuropathic pain. Symptoms of CIPN often lead to dose reduction or premature discontinuation of life‑saving cancer therapy, severely impacting patients’ quality of life and treatment outcomes.  There remains a substantial unmet clinical need because current clinical management largely relies on off-label symptomatic interventions that do not halt or reverse nerve damage

About Artivila Biopharma

Founded in late 2018, Artivila Biopharma is a clinical‑stage AI-driven biotechnology company with a diversified portfolio of therapeutic pipelines across autoimmune diseases, neurodegenerative diseases and oncology. Leveraging its proprietary “AI + HI” (Artificial Intelligence + Human Intelligence) dual-driven model, the company combines a modular AI R&D platform with the deep scientific expertise of its core team to build multiple programs in its pipeline. Artivila is committed to delivering innovative therapeutic options to patients worldwide.

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Artivila Biopharma

Email: BD@artivila.com