ABL Bio's New Parkinson's Drug Demonstrates Safety and Tolerability in US Phase 1 Trial

On September 1, ABL Bio announced that its bispecific antibody candidate 'ABL301' for the treatment of degenerative brain diseases has demonstrated safety and tolerability in a Phase 1 clinical trial in the United States.

This clinical trial was conducted from December 2022 to April this year, involving 91 adult participants. After intravenous administration of ABL301, its safety, tolerability, pharmacokinetic, and pharmacodynamic properties were evaluated.

According to the results report, both the single ascending dose (SAD) and multiple ascending dose (MAD) studies confirmed safety and tolerability, and no deaths or serious adverse events occurred among all participants.

In the SAD study, 4 out of 56 participants (7.1%) experienced at least one treatment-related adverse event (TRAE), with 2 of these cases occurring in the placebo group. All 39 participants who reported adverse events experienced only Grade 1 or 2 events.

In the MAD study, 2 out of 35 participants experienced TRAEs, and these adverse events were also limited to Grade 1 or 2.

This Phase 1 trial was led by ABL Bio. The company explained that from Phase 2 onward, Sanofi will take responsibility for the clinical development, and they are currently in the process of changing the sponsor to proceed with subsequent trials.

Previously, in January 2022, ABL Bio signed a joint development and technology transfer agreement with Sanofi for ABL301, valued at approximately 1.06 billion US dollars (about 1.47 trillion Korean won).

Lee Sanghoon, CEO of ABL Bio, stated, "The results of this Phase 1 trial will serve as important evidence for Sanofi to continue with the subsequent clinical studies. Degenerative brain diseases, including Parkinson's disease, pose a significant threat to the lives of patients and their families, but there are no fundamental treatments available, resulting in substantial unmet needs. We hope that ABL301 will become an innovative drug that offers new treatment options and improves the quality of life for patients."

ABL301 is a bispecific antibody that utilizes ABL Bio's 'Grabody-B' platform technology, which maximizes blood-brain barrier (BBB) penetration. Its key feature is the effective delivery of antibodies to the brain to inhibit the accumulation of pathogenic proteins responsible for the onset of Parkinson's disease.