K-made new stroke drugs accelerate towards commercialization

The efficacy of GNT Pharma’s Nelonemdaz was confirmed in a later-stage clinical study

Merk and AstraZeneca were unsuccessful in their attempts. However, several Korean biopharma are challenging the field with cell therapy

New candidate products for ischemic stroke developed by Korean pharmaceutical companies are proving to be effective.

 

As global pharmaceutical companies have faced difficulties in development, attention is drawn to the possibility of commercializing new stroke drugs made in Korea.

 

According to industry experts on the 17th, Phase 3 clinical demonstrated the efficacy of Nelonemdaz, a new ischemic candidate product developed by the bioventure company GNT Pharma.

 

Nelonemdaz is a derivative of aspirin and sulfasalazine, selectively inhibiting the NR2B subunit of the N-methyl-D-aspartate (NMDA) receptor, a receptor of glutamate.

 

This drug can prevent neuronal injury after surgical thrombectomy by blocking NMDA-receptor-mediated neurotoxicity and reactive oxygen species.

 

A Phase 3 clinical study investigating the efficacy of Nelonemdaz included 496 patients with moderate ischemic stroke who required surgical thrombectomy within 12 hours of contracting ischemia.

 

The patients were randomly assigned to two groups: a group receiving high doses of Nelonemdaz and another receiving a placebo.

 

After receiving the medication, patients underwent surgical thrombectomy.

 

The primary endpoint was a change in the modified Rankin Scale (mRS) score, used to measure the degree of disability in stroke patients, at 90 days after the first dose.

 

The clinical outcome showed no significant difference in mRS changes between the Nelonemdaz group and the placebo group.

 

However, among 47 patients who received the medication within one hour of emergency room arrival, there was 4.93 times greater mRS improvement in the Nelonemdaz group compared to the placebo group.

 

This result demonstrates that administering Nelonemdaz to patients with acute ischemic stroke upon early arrival at the emergency room may provide significant benefits.

 

GNT Pharma announced that it would complete the study this year and aims to launch Nelonemdaz in Korea.

 

GNT Pharma is preparing for a Phase 3 study of Nelonemdaz for indications beyond ischemic stroke, including cardiac arrest.

 

Can Korean pharma succeed in developing new stroke drugs, where global pharma companies have failed in the past? The potential commercialization of new stroke drugs draws attention because global pharmaceutical companies have repeatedly failed in clinical trials.

 

When assessing the probability of a stroke recurrence within 90 days after an ischemic stroke, AstraZeneca’s Brilinta, an antiplatelet medication, did not show a significant reduction compared to aspirin.

 

Merck’s vorapaxar, an antiplatelet medication, was unsuccessful in demonstrating efficacy, as the clinical study revealed an increased risk of intracranial hemorrhage in stroke patients.

 

Several biopharmaceutical companies in Korea are investigating the potential development of disease-modifying candidate products, including Natural Killer (NK) or stem cell therapies.

 

NK cells can detect malignant cells and kill them via necrosis.

 

They can directly attack malignant cells or secret cytokines to induce T cells and B cells to attack.

 

NKMAX explained that the new Alzheimer’s candidate product SNK01 is also effective in stroke patients.

 

NKMAX reports a significant improvement in language ability and overall energy level in stroke patients in Mexico when administering SNK01.

 

Furthermore, Phase 1a/2 clinical studies using cord-derived mesenchymal stem cell therapy ‘CordSTEM-ST,’ developed by CHA Biotech, have shown the inhibition of anti-inflammatory cytokines in stroke patients.

 

Regarding acute stroke, it is well-established that neuronal repair is impaired after a stroke.

 

However, CordSTEM-ST treatment has been found to strongly inhibit such inflammatory responses, thereby reducing neuronal damage.

 

Due to confirming the CordSTEM-ST effect, Cha Biotech plans to proceed to the later stages of clinical trials.