What is the most likely treatment for Alzheimer's?

Inspection on the Development Status of Alzheimer's Treatment in '2021 Bio Korea'

GemVax & KAEL and Aribio among domestic companies are in the preparation stage of Phase III clinical trials

Global development of Roche, Lilly, and Eisai is nearing its end

With 2021 Bio Korea held on the 9th, an innovative strategy session is being held for early diagnosis and treatment of Alzheimer

As Biogen's Aducanumab (Aduhel) was approved by the U.S.

 

Food and Drug Administration (FDA) for the first time in 18 years as a treatment for Alzheimer's, competition for development of Aducanumab.

 

Currently, Roche, Eli Lilly, Ezai, Johnson and Johnson are considered companies that have started to develop treatments for Alzheimer's.

 

In Korea, GemVax & KAEL and Aribio, Ildong, MEDIPOST, and Hyundai are developing dementia drugs.

 

Among them, Zembax and Aribio are said to be fast in development.

 

At the "2021 Bio Korea" held at COEX in Seoul on the 9th, the current status of development of Alzheimer's drugs at home and abroad was discussed under the theme of "Innovative Strategies for Early Diagnosis and Treatment of Alzheimer's Disease." In particular, the session drew keen attention due to the influence of Aducanumab's FDA approval a day ago.

 

◆Aducanumab, positive impact on development of dementia treatment drugs by domestic companies GemVax has completed phase 2 of GV1001 in Korea.

 

Earlier this year, it applied for Phase III clinical trials, but the MFDS rejected.

 

The reason was that the number of test subjects was insufficient.

 

GemVax plans to re-apply for Phase III clinical trials by recruiting additional subjects.

 

GemVax is also preparing for Phase II clinical trials in the United States.

 

"We are actively discussing the resumption of clinical trials as COVID-19 situation calms down in the U.S.," Song Hyung-gon, CEO of GemVax & KAEL, said in an announcement on the day.

 

"We are also in contact with local companies in Europe for clinical progress." Aribio is on clinical trial in the United States.

 

In March, the company announced interim results of Phase II clinical trials on AR1001.

 

In a six-month clinical trial of 210 patients, both Aribio 10 mg and Aribio 30 mg groups showed improved cognitive function.

 

In the case of Aribio 10mg group, it was observed that the cognitive function improved 25.6% compared to the placebo group at 26 weeks.

 

Based on these results, Aribio plans to apply for Phase III clinical IND in the United States within this year.

 

With 2021 Bio Korea held on the 9th, an innovative strategy session is being held for early diagnosis and treatment of Alzheimer

Ildong received approval for phase 3 clinical trials of 'ID1201' in South Korea in 2019.

 

ID1201 is a natural product derived from the Pérsian lílac fruit.

 

The company believes that the ingredient will improve cognitive function by inhibiting the production of β-amyloid and brain inflammatory substances.

 

However, it is said that it is difficult to recruit subjects due to COVID-19 situation.

 

MEDIPOST completed Neurostem's Phase I and Phase 2a clinical trials.

 

In phase 2a, statistical significance was not obtained the Alzheimer's disease evaluation scale.

 

However, MEDIPOST plans to confirm the tendency of β-amyloid levels to fall and reaffirm the results after long-term tracking by continuing clinical trials like Biogen.

 

◆Phase 3 clinical trials such as Roche's Gantenerumab and Solanezumab by Lilly are underway Colin Masters, Professor of University of Melbourne, introduced the development of global Alzheimer's drugs.

 

According to him, in addition to FDA-approved Aducanumab by Biogen, there are Gantenerumab by Roche, Solanezumab and Donanemab by Lilly, Crenezumab co-developed by Roche and Genentech, Bapineuzumab co-developed by Pfizer and Janssen, and BAN2401 jointly developed by Eisai and Biogen.

 

Progress in development confirms that Solanezumab and Gantenerumab are relatively advanced.

 

Phase III clinical trials are under way.

 

Both treatments target β-amyloid, such as Aducanumab.

 

The target is the same, but there is a slight difference in how it is involved in β-amyloid.

 

Aducanumab removes β-amyloid directly.

 

Solanezumab neutralizes toxicity in the intermediate stage of β-amyloid formation.

 

Gantenerumab prevents amyloid from accumulating in the first place.

 

The β-amyloid reduction effect shown to date is comparable to that of Aducanumab.

 

A PET scan of the brain's β-amyloid buildup showed that Aducanumab succeeded in removing 70%.

 

Gantenerumab, Lecanemab, and Donanemab are similar.

 

Bapineuzumab is 12-25% lower, while Solanezumab and Crenezumab do not have separate PET imaging data.

 

"There is no doubt that we need to treat Alzheimer's with combination drugs," Professor Masters said.

 

"We need to use a variety of mechanisms at the same time to lower our amyloid levels." However, it is appropriate to start with low capacity in the early stages and gradually increase it to high capacity."