[Transfer] Where does Alzheimer's disease hope in the second half of the second half of the year?

[Transfer] After a variety of innovative therapies folded, where does Alzheimer's disease hope in the second half of the second half of the year?

Source: Same freehand

According to a report released by the International Alzheimer Society in 2018, every 3 seconds, the world will have more Alzheimer's disease (AD) patients.

AD is a degenerative neurodegeneration disease. Clinically, comprehensive dementia, such as memory disorders, dismissal, misses, dislocation, visual space skills damage, execution dysfunction, and changes in personality and behavior changes. The cause is unknown so far.

In the past 20 years, the FDA has only approved the treatment of 5 ADs, and the total number of drugs approved at home and abroad is less than 20. This huge blue ocean has attracted many pharmaceutical companies to rush in, but from the current situation, it is not optimistic.

With the rapid increase of global prevalence, AD has been identified as the main health threat of human beings by the international medical community. In order to continuously improve everyone's attention, the international medical community set June as Alzheimer's disease and brain conscious moon. However, last month was not very good for the AD field, including some companies including Roche, Athira, Acadia and Bo Jian announced that the clinical trials of drugs developed at different stages of AD were not good.

But this track has no shortage of hope. In the second half of this year, Nuplazid, LecaneMab and other high -profile products will be approved by regulatory agencies.

1

Roche: Crenezumab missed the main end point

On June 16, Roche announced its anti-amylin-β monoclonal antibody (MAB) Crenezumab failed in Phase II test (NCT01998841). The study aims to evaluate Crenezumab's cognitive mutations that lead to early -loss ADs that cause early -rate AD to slow or prevent AD potential. Unfortunately, Crenezumab failed to reach any common endpoint of the change rate of cognitive ability or situation memory function.

Although the small value differences that are conducive to Crenezumab are observed at the common endpoint, multiple secondary end points, and exploratory endpoints, these differences are not statistically significant. Roche said preliminary data will be announced at the International Conference of Alzheimer's Association in August. Roche will give up Crenezumab or change the direction of drug development, and maybe you can get a glimpse of these data.

Roche another subcutaneous injection of Aβ antibody GANTENENERMAB may become the focus of the future. Last year, the FDA awarded GANTENERUMAB breakthrough therapy that Roche had expressed his hope to submit a listing application to the FDA as soon as possible.

Roche is evaluating the efficacy of early AD in the key III clinical trial Graduate1/2 research, which is expected to be disclosed in the fourth quarter of 2022. As a subcutaneous injection preparation, GANTENERUMAB has the potential of home administration, which is more advantageous than other similar products.

2

Acadia: NuPlazid turned from Parkinson to AD

NuPlazid (Pimavanserin) is a selective 5-hydroxylidine reverse agonist and antagonist. It was approved in 2016. It became the first drug to treat some Parkinson's patients with psychological illusions and delusions.

On June 17 this year, the FDA Psychiatric Pharmaceutical Pharmaceutical Consultation Committee opposed ACADIA's Nuplazid tablets for 9: 3 votes for the treatment of new drug applications related to AD spiritual illusion and delusion. The committee believes that the existing data cannot support NuPlazid to have a clear effect in relevant indications.

Although the FDA does not need to follow the advice of the expert group, in order to in April last year, the FDA refused to approve the illusion and delusion of Nuplazid to treat mental patients related to dementia (AD as one of the sub -groups). The FDA seemed unlikely to approve the drug.

At present, the FDA has postponed the application of the new drug supplementation of the therapy until August 4. It is worth noting that NuPlazid's sales reached $ 115.5 million in the first quarter of this year, an increase of 8%year -on -year.

3

Bo Jian: ADUHELM is dead, LECANEMAB stands up?

In June last year, the FDA announced that it approved the BLA of the BLA for the treatment of early AD patients in the treatment of early AD patients. Aduhelm is considered the first new drug approved by the FDA since 2003.

However, this move caused many questions and concerns about the production process, efficacy and annual costs of the drug, and three well -known professors resigned from the FDA consulting committee to protest the listing of ADUHELM for the FDA.

In April of this year, CMS announced that the United States Federal Medicare's coverage of Aduhelm was limited to patients participating in random control clinical trials. On June 21, the latest news released by ClinicalTribis.gov stated that Bo Jian had terminated observation iCareAD test, which aims to collect the real data used by Aduhelm in the United States.

Due to the limited number of patients with clinical trials, ADUHELM's medical insurance restrictions actually mean the end of its business prospects. Bo Jian's first quarter financial report showed that ADUHELM's first quarter sales were only $ 2.8 million. Earlier, many analysts predicted that the sales of Aduhelm in the first quarter after listing may exceed $ 10.79 million. Whether Bo Jian has the opportunity to get a wider range of ADUHELM coverage depends on the current phase IV ENVISION test. This is a verification research designed to obtain accelerated approval, but it takes several years to complete.

However, Bo Jian has shifted its focus to its second antibody β -antibody LECANEMAB. In March 2014, Wei Materials and Bo Jian signed a joint development and commercialization agreement on LECANEMAB, and Wei Materials had the final decision -making power. In May, the security material completed the application to the LecaneMab rolling to the FDA, seeking accelerated approval of biomarker -based data.

In addition, LECANEMAB has been determined by the FDA breakthrough therapy in June last year. According to the clinical trial data disclosed earlier, LECANEMAB can selectively combine to eliminate soluble, toxic Aβ agglutinations (original fibers), which are considered to promote the nerve degeneration process in AD.

The data of the Clarity AD is expected to be announced in the fall of Clarity AD, which will be obtained at that time. Bo Jian and Weiming expect to submit an application to the FDA in the 2022 fiscal year to realize the complete approval of LECANEMAB.

4

Athira: Fosgonimeton impacts "heavy bombs"

In June, Athira Pharma announced that its Fosgonimeton (ATH-1017) that it used to treat AD failed to reach the main end in the II Act-AD test.

FOSGONIMETON (ATH-1017) is a small molecule that aims to enhance the activity of hepatocyte growth factor (HGF) and its receptor MET to affect neurodegeneration and regeneration of brain tissue. In the case of nerve degeneration, the function of the HGF/MET system may be damaged in the brain.

The ACT-AD test lasts for 26 weeks to evaluate the efficacy of Fosgonimeton in the treatment of mild to medium-degree AD. The main endpoint of this study is the change of event-related potential (ERP) P300 incubation period (a functional, objective, objective work memory processing speed measurement method). CGIC) and daily life tool activities (ADCS-ADL23). In addition, the research will evaluate Fosgonimeton's plasma pharmacokinetics.

Although the trial did not reach the main end of the study, Athira pointed out that compared with placebo, patients with Fosgonimeton single drugs (with the combined use of standard acetylcholine inhibitors) pre -designated sub -group analysis showed that the ERP P300's incubation period Both the AD evaluation table-cognitive quantity table has improved.

At present, Athira has launched a light medium -sized AD FOSGONIMETON Phase III clinical trial (NCT04488419), but in this larger test, Fosgonimeton is still observed whether FOSGONIMETON will show the effect of single drug treatment. If the experiment is successful, GlobalData is expected to reach US $ 824 million in the United States by 2030.

In addition to AD, FOSGONIMETON is also expected to treat more extensive dementia people, including Parkinson's dementia and Louis dementia.

5

Hope that has not yet arrived

The success rate of AD clinical trials is the lowest in history, and new drugs developing AD can be said to be difficult. Nevertheless, the future of AD still has hope. Roche, Wei Materials/Bo Jian and Lili Lili are expected to announce the results of the phase III clinical trials of their respective AD drugs at the end of this year or early next year.

In addition, Okasuka Pharmaceutical and Lingbei Pharmaceutical announced on June 27 that during the III Test (NCT03548584), Brexpiprazole significantly reduced the restlessness of AD dementia patients.

In 2015, Brexpiprazole was approved by FDA for the treatment of adult schizophrenia and severe depression. Based on the active results of the above test, the Okasuka and Lingbei Pharmaceutical plan to submit a new drug application to the FDA later this year. GlobalData predicts that by 2030, Brexpiprazole's sales in the United States will reach $ 415 million.

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