GlobalData: "Aribio AR1001 Named One of Three Leading Next-Generation Alzheimer's Treatments"

Improved Brain Injury Biomarkers and ARIA-Free Safety Proven in Phase 2 Trials
Oral Administration Advantage Highlighted
Sales Projected to Reach $674 Million by 2033
Recognized as an Alternative to Global Big Pharma

GlobalData, a leading global bio-pharmaceutical market research firm, has identified Aribio's oral Alzheimer's disease treatment AR1001 as one of the "three key next-generation promising pipelines" that will drive the future market.

In a recently published analysis report, GlobalData projected that the Alzheimer's treatment market will experience rapid growth, increasing from $2.4 billion in 2023 to $17 billion by 2033, representing a compound annual growth rate of 21.8%. The report noted that while current amyloid antibody therapies such as Eisai and Biogen's Leqembi and Eli Lilly's Kisunla are leading the market, there are limitations to patient accessibility due to issues such as ARIA (brain edema and hemorrhage side effects) and the inconvenience of intravenous administration.

Accordingly, GlobalData highlighted three new drug candidates with novel mechanisms and formulations: Eli Lilly's next-generation antibody therapy Remternetug, Annovis Bio's Buntanetap, and Aribio's AR1001, as treatments that warrant attention.

Aribio AR1001: "Oral Administration, No ARIA, Distinct Mechanism"-Three Key Strengths

Aribio's AR1001 is an oral treatment in the PDE5 inhibitor class, optimized for chronic disease management with once-daily dosing. Unlike existing antibody therapies that directly remove amyloid, AR1001 employs a novel mechanism that maintains and improves cognitive function by increasing cerebral blood flow and directly protecting neurons.

Notably, in Phase 2 clinical trials, plasma biomarker (pTau-181) levels improved significantly compared to the placebo group, and among patients with confirmed Alzheimer's pathology, both cognitive function and daily living abilities were shown to improve. Most importantly, no cases of ARIA side effects-commonly observed with antibody therapies-were reported.

The ongoing Phase 3 POLARIS-AD clinical trial is being conducted over 52 weeks, with the primary endpoint being changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB). The trial also comprehensively evaluates efficacy using ADAS-Cog13, MMSE, activities of daily living assessment (A-iADL), and blood and cerebrospinal fluid biomarkers. Top-line results are expected to be announced at the end of the second quarter of 2026.

GlobalData: "Sales Projected at $674 Million by 2033"

GlobalData stated that AR1001 "simultaneously possesses the strengths of convenient administration, a differentiated mechanism, and ARIA-free safety," and assessed that "it has the potential to achieve sales of $674 million (approximately 900 billion KRW) by 2033." This projection assumes Aribio markets the drug independently, and even higher sales are anticipated if the company partners with globally influential firms.

The report also noted, "While global pharmaceutical companies currently dominate the market with antibody therapies, there is rapidly growing demand for oral new drug candidates that offer the convenience and safety required for long-term treatment," and analyzed that "AR1001 is an alternative pipeline capable of meeting these needs."

Erella Dana, GlobalData's Head of Neurology and Immunology, explained, "This drug scored highly in GlobalData's competitive assessment for its novel mechanism of action and the convenience of oral administration, and, as demonstrated in preclinical studies, it potentially offers significant disease-modifying capabilities."

She added, "The differentiated mechanism and favorable administration profile of this drug position it as an attractive alternative to the current generation of complex anti-amyloid therapies. Aribio is actively pursuing major licensing partnerships, a strategy that can address the commercial limitations of being a small biotechnology company."

A representative from the domestic pharmaceutical and biotechnology industry commented, "GlobalData is a highly trusted institution whose reports are referenced by multinational pharmaceutical companies and global investment organizations for decision-making. For a Korean company's pipeline to be officially named as a global key candidate by such an institution is a very meaningful achievement."

The representative continued, "The Alzheimer's treatment market has the potential to grow by tens of trillions of won worldwide. If AR1001 secures a licensing agreement or joint development partnership with a global pharmaceutical company, it could significantly enhance the company's value."