ABL Bio announced on the 1st that it confirmed the safety and tolerability of the treatment candidate ABL301 (SAR446159) for degenerative brain diseases such as Parkinson's disease in a U.S. Phase 1 clinical trial.
The trial was conducted from December 2022 to April this year, involving 91 healthy adults. It was divided into two parts: a single ascending dose (SAD) and a multiple ascending dose (MAD), with 56 and 35 participants, respectively. The primary endpoint was the adverse reactions that occurred after treatment.
As a result, no serious adverse reactions were observed, and most adverse reactions were confirmed to be mild, at grades 1 to 2. In the SAD, 4 out of 56 participants (7.1%) experienced treatment-related adverse reactions (TRAE·Treatment Emergent Adverse Events), while in the MAD, 2 out of 35 participants (5.7%) experienced them.
ABL301 is a dual antibody that applies the blood-brain barrier penetration technology 'Grabody-B platform' to inhibit the accumulation of alpha-synuclein, which is the cause of Parkinson's disease, and effectively deliver drugs into the brain.
ABL Bio signed a contract in 2022 with the French pharmaceutical company Sanofi for the transfer of exclusive rights to develop and commercialize the candidate. Sanofi is currently conducting follow-up clinical trials and is undergoing the process to change the clinical trial sponsor.
CEO Lee Sang-hoon noted, 'The Phase 1 results of ABL301 are evidence supporting the follow-up trials,' adding, 'I hope it will become an innovative treatment that can provide new therapeutic options for patients with Parkinson's disease.'
ABL Bio is developing a total of eight pipelines, including ABL001, ABL202, and ABL111, in clinical and non-clinical phases in the U.S., China, Australia, and Korea, with some products receiving Fast Track designation from the U.S. Food and Drug Administration (FDA).