2024-02-29 22:00:00
Images related to the development of new drugs for stroke./Photo = Shutterstock, Graphics = Designer Eunsil Kim
[시사저널e=김지원 기자] Domestic stroke drug development is accelerating. 8 out of 10 stroke patients are over 60 years old, so it is also called the ‘aging society time bomb’, but it is an area where new treatments are not active. This is because development is difficult due to difficulties in recruiting clinical patients. Attention is being paid to whether global pharmaceutical companies will be able to launch new stroke drugs domestically, which have failed several times.
According to the industry on the 1st, research and development of new stroke drugs in Korea are actively underway. GNT Pharma plans to conduct the second phase 3 clinical trial of the stroke treatment drug ‘Nelonemdaz’ under development. Dr. Noah Biotech plans to release a new drug that can be used in stroke stabilization to prevent complications. Jeil Pharmaceutical has completed Phase 2a of the related pipeline.
Stroke is a cerebrovascular disease in which blood vessels supplying blood to the brain become blocked or burst. It refers to both cerebral infarction, in which a cerebral blood vessel is blocked, and cerebral hemorrhage, in which blood leaks into the brain tissue due to a rupture of a cerebral blood vessel. According to the Health Insurance Review and Assessment Service, stroke has a high fatality rate, ranking as the fourth leading cause of death in Korea. When brain cells are damaged due to a stroke, various followingeffects such as hemiplegia and speech impairment may be left behind.
The size of the stroke treatment market is expected to expand. The current stroke treatment market size is estimated at 16 trillion won, and demand is expected to grow further as we enter an aging society. Stroke is more commonly observed in the elderly. Eight out of 10 stroke patients are over the age of 60, and the incidence of cerebral hemorrhage per 100,000 people is 34 times higher in people in their 70s or older than in those in their 30s.
However, despite the high demand, there are not many treatments available on the market. The main treatment is thrombolytic drug (tPA), which is used to treat acute cerebral infarction. It is a drug that dissolves already formed blood clots. It was developed in 1997 and is administered as an emergency intravenous injection. It is known that there is no other suitable treatment. Accordingly, the industry expects that if a new stroke treatment drug emerges, it will become a blockbuster new drug.
Domestic pharmaceutical and bio companies are also speeding up the development of stroke treatments.
GNT Pharma is developing a new stroke drug, Nelonemdaz. Nelonemdaz is a multi-target brain neuroprotective drug that prevents the death of brain neurons following stroke. It inhibits the activity of N-methyl-D aspartate (NMDA) receptor, a neural receptor that regulates signaling between brain cells in inflammatory macrophages. At the same time, it removes free radicals and blocks excitatory neurotoxicity and free radical toxicity, which are the causes of brain cell death following stroke.
According to the results of the phase 3 clinical trial of Nelonemdaz recently announced by GNT Pharma, the drug’s effectiveness was confirmed. This phase 3 clinical trial of Nelonemdaz was conducted on patients with severe stroke who underwent intra-arterial thrombectomy within 12 hours of onset. The 496 patients who participated in the clinical trial received the drug within 7 hours of arriving at the emergency room following onset. At the same time, thrombectomy was performed and the effectiveness and safety of disability improvement were analyzed following 12 weeks.
As a result, when nelonemdaz was administered to patients within one hour of arriving at the emergency room following a stroke, the effect of improving disability was nearly five times higher than that of placebo. Significant improvement in disability was also observed in 79 patients who received the drug within 70 minutes of arriving at the emergency room.
GNT Pharma plans to conduct additional multinational phase 3 clinical trials for nelonemdaz. The goal is to confirm whether the patient’s disability improves when nelonemdaz is administered along with thrombectomy following arrival at the emergency room through the second phase 3 clinical trial.
A GNT Pharma official said, “Regarding the second phase 3 clinical trial, we are discussing various options, including cooperation with overseas companies and self-promotion.”
Dr. Noah Biotech, an artificial intelligence (AI)-based new drug development company, is developing a new drug ‘NDC-002’ to be used in the stable phase of stroke rather than the acute phase. Most stroke drugs currently prescribed are for acute use. The thrombolytic agent tPA is injected within 4 hours following the onset of a stroke, and aspirin and warfarin are prescribed within 48 hours.
On the other hand, there are almost no medications to prevent and manage complications during the stable phase of stroke. Even if stroke is treated in the acute stage, followingeffects such as cognitive impairment may remain depending on the patient. Accordingly, Dr. Noah Biotech plans to introduce a treatment that prevents and manages stroke complications.
./Data = each company, Table = Designer Seungah Jeong
The NDC-002 pipeline is a new drug combination that combines drugs that have already been released. Dr. Noah Biotech’s complex drug candidate derivation AI platform ‘ARK’ was used. It is explained that the number of combinations with a high possibility of compounding drugs is in the hundreds of millions, but by using the AI platform, the number of combinations of 100 million can be reduced to 1/1000 in 3 months. NDC-002 contains donepezil, which is used as an existing dementia treatment.
Currently, NDC-002 has completed phase 1 clinical trials in Korea. We plan to prepare for phase 2 clinical trials in the U.S. through funding. An official from Dr. Noah Biotech said, “We plan to receive approval and conduct clinical trials in the U.S. for either the stroke or amyotrophic lateral sclerosis (ALS) pipeline this year.”
As such, the development of stroke treatments is accelerating in Korea, but some say that developing related new drugs will be difficult.
An industry insider said, “Strokes often cause sudden collapse,” and “since there is no warning, it is difficult to find patients for clinical trials.”
Global pharmaceutical companies have also failed to develop new drugs for stroke. AstraZeneca’s anti-thrombotic drug ‘Brilinta’ failed to prove effectiveness in stroke patients. Merck’s antithrombotic drug ‘Vorapaxa’ has shown a serious risk of bleeding in some patients.
Development of Korea’s Jeil Pharmaceutical’s stroke pipeline ‘JPI-289’ has also been temporarily halted. JPI-289 completed phase 2a clinical trials in the third quarter of 2021, but plans for phase 3 clinical trials have not yet been announced.
An official from Jeil Pharmaceutical said, “We are looking for overseas partnerships to conduct phase 3 clinical trials due to cost issues, etc.” and “We are continuing our efforts to establish partnerships in overseas academic societies, but there is no progress yet.” He added, “Currently, the development of the JPI-289 pipeline has been temporarily halted, and there are no plans for its own phase 3 clinical trial.”
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