Korean biotech and pharmaceutical companies are actively developing Alzheimer’s disease treatments in various forms, such as stem cell therapy and peptide drug.
Korea Biotech Industry Organization (Korea BIO) published a report on the analysis of Alzheimer’s disease and the treatment development trends on Monday.
According to the report, developing an Alzheimer’s drug is extremely difficult to succeed, and many researchers face failure in phase 3 studies.
However, to secure an Alzheimer’s treatment market as soon as possible, drug companies are working on about 170 pipelines worldwide in 2022.
Alzheimer’s disease treatment developers include GemVax & Kael, CHA Biotech, AriBio, D&D Pharmatech, and ABL Bio in Korea.
In January, GemVax & Kael obtained the Ministry of Food and Drug Safety’s nod for a phase 3 clinical trial of GV1001, a peptide drug, to treat severe Alzheimer’s. The company expects that GV1001’s protection of the nerve cells could effectively treat Alzheimer’s.
CHA Biotech is working on a stem cell therapy-based Alzheimer’s drug. The company developed “neuronal progenitor cell” culture technology to induce mass-proliferated neural progenitor cells to differentiate into nerve cells. The company hopes that the technology could help treat neurological diseases, including Alzheimer’s and Huntington’s.
D&D Pharmatech is developing a neurodegenerative disease treatment, NLY01.
In 2020, the company received FDA approval for a phase 2b trial of the drug to treat Alzheimer’s.
AriBio aims to develop a multi-mechanism drug to suppress the progression of dementia and improve cognitive function. AriBio discovered the treatment candidate AR1001 using its ARIDD drug development platform. As a result, the company ended a U.S. phase 2 trial and began a global phase 3 study.
ABL Bio is studying an antibody, ABL301, using “GrabBody-B,” a blood-brain barrier (BBB) shuttle platform, to treat degenerative brain diseases.
Celltrion and Icure Pharmaceutical obtained the local permit for a patch-type donepezil drug for Alzheimer’s in a joint development project.
Other companies are also expected to develop various formulations to commercialize donepezil, other than a pill or an injection.
Korea BIO said in the report that studies on Alzheimer’s treatments have made significant progress. Researchers could produce imaging through markers specific to amyloid-beta accumulation and tau accumulation in the brain and diagnose the disease by measuring amyloid beta and phosphorylated tau in blood and cerebrospinal fluid (CSF).
Still, the organization said there are not many markers, except for a biomarker for amyloid, that was verified, approved, and used in real clinical care.
Despite challenges, Alzheimer’s researchers are developing various diagnostic and treatment methods to measure changes in brain activity and body fluid metabolites and assess the severity of the disease, Korea BIO said.
“As the clinical diagnosis of Alzheimer’s requires high sensitivity and specificity of a biomarker, companies should consider this when developing diagnostic methods in the future,” it said.
Korea BIO mentioned the case of Biogen’s Aduhelm, which obtained conditional approval under the FDA’s fast-track policy but was rejected from the EU’s authorization due to a lack of data to prove clinical usefulness.
“As the success probability of a new drug development (for Alzheimer’s) is low, it is important for the government to actively support the industry and devise a long-term strategy to respond to the private sector’s demand,” Korea BIO said.
The fact that most Alzheimer’s studies are about disease-modifying therapies (DMTs) indicates that researchers worldwide are searching for a real cure for Alzheimer’s, the report went on to say.
“The future treatment for Alzheimer’s disease will have to change from ‘relief’ to ‘cure,’” it added.