HomeInvestors & MediaNews
- Confirmed safety and tolerability of ABL301 (SAR446159) in healthy adults
- Sanofi to conduct following clinical study of ABL301 (SAR446159) after transfer of sponsorship
Seoul (South Korea) – September 1, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that it has confirmed safety and tolerability of ABL301 (SAR446159), a bispecific antibody candidate for the treatment of neurodegenerative diseases such as Parkinson’s disease, in Phase 1 U.S. clinical trial in healthy adults.
ABL Bio conducted Phase 1 clinical trial from December 2022 to April 2025 in 91 healthy adults to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ABL301 (SAR446159) administered via intravenous injection. The Phase 1 study consisted of two parts: a Single Ascending Dose (SAD) study and a Multiple Ascending Dose (MAD) study, enrolling 56 and 35 participants respectively. The primary endpoints were safety and tolerability, which were assessed based on indicators such as treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
According to the clinical study report, ABL301 (SAR446159) demonstrated safety and tolerability in both the SAD and MAD studies, with no deaths or serious adverse events (SAEs) reported in any participants. In the SAD analysis, 4 out of 56 participants (7.1%) experienced at least one treatment-related adverse event (TRAE), and 2 of those 4 participants were in the placebo group. Additionally, 39 out of 56 participants (69.6%) reported at least one treatment-emergent adverse event (TEAE), all of which were classified as Grade 1 or Grade 2.
In the MAD study, 2 out of 35 participants (5.7%) experienced at least one treatment-related adverse event (TRAE), while treatment-emergent adverse events (TEAEs) were reported in 20 out of 35 participants (57.1%). All TEAEs reported in the MAD study were also classified as Grade 1 or Grade 2.
In January 2022, ABL Bio entered into a licensing agreement with the biopharma company Sanofi, granting Sanofi exclusive rights for the development and commercialization of ABL301 (SAR446159). Currently, the two companies are in the process of transferring the clinical trial sponsorship of ABL301 to Sanofi to conduct following clinical studies.
Sang Hoon Lee, CEO of ABL Bio said, “The results of this Phase 1 trial provided supporting evidence for Sanofi’s decision to advance the following clinical development of ABL301 (SAR446159). Neurodegenerative diseases such as Parkinson’s disease seriously threaten the quality of life of patients and their families, yet there are still no fundamental treatments available, resulting in a significant unmet need. We hope that ABL301 will offer Parkinson’s patients a new treatment option and become an innovative therapy that improves their lives.”
ABL301 is a bispecific antibody developed using ABL Bio’s ‘Grabody-B’ platform technology, which has the potential to effectively deliver antibodies into the brain to inhibit the accumulation of alpha-synuclein—the cause of Parkinson’s disease—thereby potentially enhancing therapeutic efficacy. The Grabody-B platform utilizes the Insulin-like Growth Factor 1 Receptor (IGF1R) to maximize the potential penetration of various neurodegenerative disease drug candidates across the blood-brain barrier (BBB).
About ABL Bio
ABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. Clinical projects for 8 pipelines, including ABL301 (SAR446159), ABL001 (tovecimig), ABL111 (givastomig), ABL503 (ragistomig), ABL105 (YH32367), ABL104 (YH32364), ABL202, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. ABL001 (tovecimig) has received Fast Track designation by the U.S. Food and Drug Administration (FDA). In addition, ABL111 (givastomig), co-developed with I-Mab, has presented encouraging data from the Phase 1b clinical trial evaluating the triple combination therapy with nivolumab and chemotherapy in ESMO GI 2025. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs).