November 29, 2024

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ABL Bio's corporate logo (ABL Bio)

Despite a regulatory setback for ABL Bio's degenerative brain disease medicine's approval, the South Korean biotech company said Tuesday that it will continue its studies for the new drug with lessened dosages, possibly starting at the end of this year.

The US Food and Drug Administration decided to suspend part of ABL Bio's clinical trials for the development of brain diseases drug ABL301 on Nov. 22.

"The company will initiate clinical trials by administering dosage of 20 milligrams per kilogram or less to its patients, in accordance with the FDA's regulations," an official from ABL Bio told The Korea Herald.

ABL Bio has recently submitted Investigational New Drug Applications, or IND, to the FDA and planned a dosage of up to 80 milligrams per kilogram per dosage for the new drug's clinical trials.

However, the company received a “partial clinical hold” for ABL301 trials in light of recent cases where inoculations made during clinical trials were suspected to have caused amyloid-related imaging abnormalities, or ARIAs. Such imaging abnormalities can connote cerebral hemorrhage, cerebral edema and even death for some of its patients.

"As reasons for the suspension of our ABL301 clinical trials, we suspect that the unfortunate side effects caused by Biogen's medicines has strengthened the US’ standard for degenerative brain disease-related clinical trials," she said.

US biotechnology company Biogen's Alzheimer's disease medicine Aduhelm was the toast of the pharmaceutical industry last year after the treatment received conditional approval from the FDA for its clinical trials, for the first time in the world.

However, controversy surrounding its efficiency ensued after Aduhelm produced brain swelling in 35 percent of treated patients.

Moreover, clinical trials for another Biogen candidate, Alzheimer's disease medicine Lecanemab, had also been under fire after clinical trial results showed that 12.6 percent of treated patients suffered from increased probability of cerebral edema.

"With such examples, we are assuming that the US' standards for clinical trials regarding degenerative brain diseases have risen," the official said.

Currently, ABL Bio is applying for permission to ship ABL301 produced by Chinese biologics technology platform WUXi Biologics to the US for administration to clinical trial patients.

Submission of additional data for high-dose administrations are also scheduled, after the company initiates further non-clinical research with the GLP Tox Study, a toxicology study conducted in compliance with laboratory practice standards endorsed by the FDA. 

By Lee Yoon-seo (yoonseo.3348@heraldcorp.com)