K-pharma advances in new Alzheimer’s drug discovery

Aribio has submitted the IND of the European Phase 3 clinical trials and is conducting Phase 3 clinical trials in Korea and the United States.

GemVex & CHA Biotech have entered Phase 2 clinical trials utilizing the a ‘multimodal mechanism’ for their drug candidates.

New drugs for treating Alzheimer’s disease developed by Korean pharmaceutical companies have entered the late phase of clinical trials, and industry watchers are closely monitoring their potential for commercialization.

 

Aribio has recently submitted an Investigational New Drug (IND) application for its oral treatment candidate AR1001 for Alzheimer’s disease, to eight European countries.

 

Aribio is about to enter the late phase of clinical trials in Europe, following its success in initiating Phase 3 clinical trials in Korea and United States.

 

Additionally, each of the new Alzheimer’s disease drug candidates developed by GemVex, CHA Biotech, and NKMAX has entered Phase 2 clinical trials.

 

The Korean pharmaceutical companies including Aribio (candidate product: AR1001), GemVex (candidate product: GV1001), CHA Biotech (candidate product: CB-AC-02), NKMAX (candidate product: SNK01), Shaperon (candidate product: Nucerin), and Neurorive (candidate product: NR-0701), and others are advancing in new Alzheimer’s drug developments.

Aribio entered Phase 3 clinical trials in the United Sates…GemVex has concluded Phase 2 clinical trials in Korea and is preparing for global clinical trials. According to the industry on the 6th, Aribio submitted a European IND application on the 26th of last month for the approval of a global Phase 3 clinical trials called ‘Polaris-AD’ for AR1001.

 

The European clinical trials will enroll 400 patients with early Alzheimer’s disease from eight European countries, including the U.K., France, Germany, Spain, Italy, Denmark, Netherlands, the Czech Republic, and Slovakia.

 

AR1001 utilizes multimodal mechanisms to target the underlying causes of Alzheimer’s disease, such as PDE5 and toxic proteins.

 

In 2022, Phase 3 clinical trials were initiated in the United States, and these trials are recruiting patients and administering the drug at 60 major clinical sites across the United States.

 

Samjin Pharmaceutical holds exclusive sales rights for AR1001 in Korea.

 

Samjin Pharmaceutical and Aribio have signed a joint development of Phase 3 trials in Korea, as well as the exclusive sales rights for the domestic market.

 

Both companies are currently conducting Phase 3 trials in Korea.

 

In Phase 2 clinical trials, AR1001 demonstrated therapeutic effects in patients with elevated levels of blood pTau-181, a significant factor associated with Alzheimer’s disease.

 

Additionally, the AR1001 10mg cohort demonstrated a decrease in cognitive decline compared to the placebo group, while the AR1001 30mg cohort demonstrated enhancements in cognitive abilities related to pattern recognition.

 

GemVex is currently developing GV1001, a candidate multimodal treatment for Alzheimer’s disease.

 

GV1001 has successfully concluded the Korean Phase 2 clinical trials and is preparing for global Phase 2 clinical trials.

 

GV1001 binds to the Gonadotropin-releasing hormone receptor (GnRHR) expressed in microglia and astrocytes, effectively suppressing neuroinflammation.

 

By binding to GnRHR, present on these two cell types, GV1001 functions as a cytokine that modulates brain immune responses.

 

GemVex will conduct simultaneous clinical trials in seven European countries using the Phase 2 clinical trials IND application submitted to the FDA.

 

The clinical trials will evaluate the therapeutic effects and safety of the drug with 185 moderate to severe patients administered with doses of 0.56 mg and 1.12 mg over 52 weeks.

 

CHA Biotech is conducting Phase 1/2a clinical trials for its new drug candidate CB-AC-02.

 

CB-AC-02 is a stem cell therapy utilizing placenta-derived mesenchymal stem cells and is under development using mass culture and cryopreservation techniques.

 

NKMAX is currently developing the cell therapy SNK01 through its subsidiary NKGen Biotech.

 

The company has successfully completed the drug administration to patients enrolling in the Phase 1/2a clinical trials.

 

SNK01 is designed to recognize and eliminate reactive T cells and damaged neurons, thereby reducing neuroinflammation and improving the overall brain immune system.

 

In the Phase 1 clinical trials conducted in Mexico, NKGen Biotech’s SNK01 demonstrated the therapeutic effects in patients with moderate to severe Alzheimer’s disease.

 

Three out of ten patients who were administered SNK01 showed improved symptoms in the AD Composite Score (ADCOMS), while six patients showed no change without further deterioration.

 

Furthermore, the FDA has granted permission to continue the Phase 1/2a clinical trials without requiring preclinical trials, based on the results obtained from the Mexico Phase 1 clinical trials.

 

Neurorive and Shaperon, completing pre-clinical trials, aim to enter a late phase of clinical trials. Shaperon is developing NuCerin for treating patients with moderate to severe Alzheimer’s disease.

 

NuCerin is designed to inhibit microglia and TNF-α production and under development to alleviate neuroinflammation.

 

NuCerin is currently in the Korean Phase 1 clinical trials.

 

Nucerin demonstrated no Dose Limiting Toxicities (DLT) up to the third level of dosage during the trial, following a dose escalation design.

 

Additionally, Shaperon signed a technology transfer contract with Kukjeon Pharmaceutical in March 2021.

 

Neurorive is currently conducting Korean Phase 1 clinical trials for their candidate product NR-0701.

 

NR-0701 utilizes acetylcholinesterase and phosphodiesterase (PDE) inhibitors, which are the active ingredients found in medications like Donepezil, used for Alzheimer’s disease, and Viagra, respectively.

 

Through this mechanism, Neurorive aims to achieve effects that are comparable to increased therapeutic effects of Alzheimer's disease drug Donepezil while simultaneously reducing the toxicity associated with Viagra-class drugs, maximizing neurotransmission capacity.