ABL Bio Applies for Phase 1 Clinical Trial in the US for Parkinson's Disease Treatment

Sanofi's Technology Out-licensing up to 1.5 Trillion KRW
Application of BBB Penetrating Bispecific Antibody Technology

[Asia Economy Reporter Chunhee Lee] ABL Bio announced on the 4th that it submitted an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) on the 30th of last month (local time) to enter Phase 1 clinical trials for its bispecific antibody candidate 'ABL301,' being developed as a treatment for Parkinson's disease.

In this clinical trial, ABL Bio plans to evaluate the safety and tolerability of ABL301 monotherapy in 68 healthy adult men and women aged 18 to 55.

ABL301 was licensed to the global big pharma Sanofi in January under a non-refundable upfront payment of $75 million (approximately 107.6 billion KRW), with milestones and other payments totaling up to $1.06 billion (approximately 1.52 trillion KRW).

ABL301 is a bispecific antibody drug candidate that combines an antibody targeting aggregated alpha-synuclein with the BBB shuttle platform (Grabody-B), which targets IGF1R to maximize blood-brain barrier (BBB) penetration. The Phase 1 clinical trial is being co-developed under the leadership of ABL Bio, while Sanofi will lead the process from Phase 2 clinical trials through commercialization.

Parkinson's disease is a degenerative brain disorder caused by the progressive loss of dopamine-secreting nerve cells. It manifests as motor impairments such as slowed movement and muscle rigidity. Approved treatments to date only supplement the deficient dopamine to alleviate symptoms and slow disease progression, resulting in a high level of unmet medical needs.

Recently, Anobis Bio received FDA approval for a Phase 3 clinical trial of its oral Parkinson's disease treatment candidate 'Buntanetap,' intensifying the development competition. Additionally, in South Korea, DND Pharmatech ('NLY01') and Kainos Medicine ('KM-819') are also developing Parkinson's disease treatments.

Lee Sang-hoon, CEO of ABL Bio, stated, “BBB penetration is a very important aspect in developing treatments for degenerative brain diseases, and we expect to confirm the safety of the new BBB shuttle target IGF1R through the Phase 1 clinical trial of ABL301.” He added, “The two companies will work closely to accelerate the development of ABL301 and do their best for the better lives of patients with degenerative brain diseases who do not lose hope even in difficult circumstances.”