L&J BIO (CEO Ho-Jun Lee) announced that its new drug candidate “AL04,” developed to treat Alzheimer’s disease as its core pipeline, was granted a patent (Patent No.: US 12,115,212 B2) by the United States Patent and Trademark Office (USPTO) on October 15.
This patent relates to a drug that simultaneously removes amyloid beta and tau proteins, which are known as the main causes of Alzheimer’s disease, and is gaining global attention as a novel treatment method.
Alzheimer’s disease is known to occur due to the accumulation of amyloid beta plaques and tau protein tangles in the brain. The treatment goal for Alzheimer’s disease, which was difficult to define, has been established by the U.S. National Institute on Aging and the Alzheimer’s Association (NIA-AA) and recommended by the FDA for clinical trials as reducing amyloid beta plaques and tau plaques.
Most existing treatments have targeted only amyloid beta, but AL04 has a unique mechanism that removes both amyloid beta and tau proteins. The title of L&J BIO’s patent is “Method for simultaneously reducing amyloid beta plaques and tau plaque deposition in Alzheimer’s disease patients using cystatin C fusion protein.” This is considered a breakthrough in the newly defined treatment goals for Alzheimer’s disease.
One of the main components of AL04, cystatin C, inhibits amyloid beta while preventing excessive phosphorylation of tau protein, thereby reducing the accumulation of these two proteins. Additionally, a special peptide helps the drug effectively cross the blood-brain barrier (BBB) and deliver it inside brain cells. Due to these actions, AL04 is likely to be applicable to a broader range of Alzheimer’s patients compared to existing antibody therapies.
With this U.S. patent registration, L&J BIO has secured exclusive rights in the United States, the world’s largest therapeutic market. The company also explained that patent examinations are currently underway in major countries such as Europe, Korea, Japan, and Australia, and once patent registrations are sequentially completed in other countries, it is expected to gain competitiveness in the global market.
L&J BIO received global pharmaceutical industry attention by presenting the outstanding mechanism and efficacy of AL04 at the Alzheimer’s Association International Conference (AAIC) held recently in Philadelphia, USA, and at BIO USA 2024 (BIO International Convention 2024), the world’s largest biotech event.
In addition to AL04, the company is researching various new drug candidates for Parkinson’s disease, amyotrophic lateral sclerosis (ALS), diabetes, hair loss, and chronic pain treatments, and plans to continue more active research and development following this U.S. patent registration.
An L&J BIO official stated, “We are very pleased to have achieved this patent registration after 12 years of research in both Korea and the United States,” and expressed the ambition to expand its presence in the global bio market through new drug development for various diseases in the future.
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