Electronic drugs show potential to conquering Alzheimer's

Remed confirms improvement in dementia diagnostic indicators in clinical trial

AriBio is developing an electric drug that uses vibroacoustic stimulation

The Korean pharmaceutical bio industry is making a bid into the electronic drug market for Alzheimer's disease.

 

Recently, Remed unveiled the results of its transcranial magnetic stimulation (TMS) therapy that demonstrated an effect in treating Alzheimer's disease.

 

AriBio, which is developing a new drug for Alzheimer's disease, is developing an electronic drug that uses vibroacoustic stimulation On July 7, Remed disclosed clinical results showing that an electronic drug being developed by Remed was effective in patients with Alzheimer's disease.

 

Remed is a Korean biotech company that has been identifying the potential of electronic drugs in various areas including depression, attention deficit hyperactivity disorder (ADHD), and dementia.

 

The electronic drug being developed by Remed for Alzheimer's disease uses transcranial magnetic stimulation.

 

Transcranial magnetic stimulation is a brain stimulation procedure that uses magnetic fields to stabilize or activate brain nerve cells in a specific area at the base of the skull.

 

It has been used to treat various brain disorders such as depression, intractable obsessive-compulsive disorder (OCD), and chronic pain.

 

Remed’s subsidiary NextCure’s helmet-type wearable electronic therapy

Remed has confirmed a change in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), an important indicator in the diagnosis of dementia, with its electronic drug in clinical development.

 

The clinical trial was conducted from May 2020 to April 2022 to evaluate the efficacy and safety of the electronic drug in 30 patients with Alzheimer's disease.

 

Trial results showed that the ADAS-Cog value of patients treated with the electronic drug improved significantly compared to those who did not receive treatment.

 

More specifically, the change in ADAS-Cog values was above the ADAS-Cog MCID threshold of 4.0, which is regarded as a clinically significant change in dementia medications, and showed no serious adverse events.

 

"These results suggest that transcranial magnetic stimulation may be effective in Alzheimer's patients in addition to depression, intractable OCD, chronic pain, and stroke," said the researchers involved in the trial.

 

Remed plans to complete the exploratory trial and submit a confirmatory IND to the Ministry of Food and Drug Safety.

 

AT&C is developing a treatment system that combines an electronic drug that uses transcranial magnetic stimulation and digital therapeutics (DTx) for the treatment of mild Alzheimer's disease.

 

The company is currently conducting a confirmatory clinical trial with 158 patients at Korea University Anam Hospital, Dong-A University Hospital, Chonnam National University Hospital, Jeonbuk National University Hospital, Chung-Ang University Gwangmyeong Hospital, Chungnam National University Hospital, and Hanyang University Hospital.

 

According to the company, the combination of transcranial magnetic stimulation and digital therapeutics showed better and longer treatment effects than conventional medication and cognitive training, which showed low treatment effects and short treatment duration.

 

In addition to Remed and AT&C, another company, AriBio, is developing electronic drugs for Alzheimer's disease.

 

In May, Aribio received approval from the Ministry of Food and Drug Safety to conduct a clinical trial for an electronic drug that uses vibroacoustic stimulation on Alzheimer's disease patients.

 

The company’s brain vibroacoustic stimulation electronic drug offers a new approach to treating Alzheimer's disease.

 

The company explained how their trial is the first clinical trial of an electroacoustic brain stimulation device that uses vibroacoustic stimulation, although there have been devices that use electric, electromagnetic field, and ultrasonic methods in the past.

 

The clinical trial will be conducted by Professor Sang-Yoon Kim’s team from the Seoul National University Bundang Hospital, to confirm the efficacy and safety of brain vibroacoustic stimulation.

 

The efficacy of the electronic drug will be evaluated in a double-blind, 6-month trial in 30 patients with early-stage Alzheimer's disease, including those with mild cognitive impairment.

 

If the exploratory clinical trial confirms the efficacy of the electronic drug, AriBio aims to launch the electronic drug for dementia by 2026 after conducting a confirmatory clinical trial.

 

In addition to the electronic drug, AbiBio is also conducting a Phase III clinical trial on AR1001, a novel drug candidate for Alzheimer's disease.

 

AR1001 targets multiple causes of Alzheimer's disease, including the PDE5 protein.

 

Recently, studies have shown that phosphodiesterase 5 (PDE5) inhibitors, such as Viagra and Cialis, are effective in preventing Alzheimer's disease, raising interest in AR1001's commercialization potential.

 

The introduction of electronic drugs in the field...will Alzheimer's disease finally be conquered?

Eisai and Biogen’s Alzheimer’s treatment

Alzheimer's disease has been a challenging area for drug development.

 

After the hypothesis that Alzheimer's disease is caused by amyloid beta emerged, targeted drugs were developed, and then were found ineffective.

 

One such drug was Eisai’s Aduhelm (aducanumab).

 

The amyloid beta hypothesis was highly suspect, so there was not much confidence in the drug, but the drug worked.

 

However, Aduhelm was withdrawn from the market due to its high price and concerns about side effects.

 

Then came Leqembi (lecanemab), developed by Eisai and Biogen.

 

Leqembi showed efficacy in early-stage Alzheimer's disease in clinical trials and has cleared regulatory hurdles in South Korea, the U.S., Japan, and China.

 

Lilly’s Alzheimer’s treatment

More recently, Lilly's Kisunla (donanemab) has also been approved by regulatory authorities.

 

Kisunla was shown to delay cognitive deterioration in patients with early Alzheimer's disease in the Phase III TRAILBLAZER-ALZ2 study.

 

In the study, donanemab delayed cognitive deterioration regardless of disease progression or pathologic stage.

 

However, there is currently no cure for Alzheimer's disease.

 

Although Leqembi and Kisunla have emerged, experts believe that they are only effective in patients with early-stage Alzheimer's disease.

 

This is why the pharmaceutical industry continues to tackle Alzheimer's disease with a variety of possibilities, including not only new drugs but also electronic drugs and digital therapeutics.

 

To date, clinical trials using electronic drugs have been limited to exploratory trials, but if they show effectiveness in confirmatory trials, they may also show synergy with the new drugs on the market.