(Health Korea News / Siwoo Lee) Dong-A ST is accelerating the development of new drugs by significantly expanding its investment in research and development. Donga ST, which consistently invests more than 10% of its sales in research and development (R&D) every year, invested more than 18% of its sales in R&D in the first half of this year.
Dong-A ST’s investment in research and development is yielding results, and it appears to be entering the global market in earnest. A representative example is the Stelara biosimilar ‘IMULDOSA (project name DMB-3115)’, which is expected to be the next-generation growth engine.
Imuldosa, which is about to be launched globally, received product approval from the U.S. FDA on the 10th. This is the second FDA approval following the antibiotic ‘Sivextro’ that received FDA approval in 2014, and Dong-A ST has once again proven its global-level R&D capabilities.
Dong-A ST signed a global licensing out agreement with multinational pharmaceutical company Intas and Imuldosa in 2021. Intas plans to pursue the commercialization of Emuldosa in the Stellara market, worth approximately 28 trillion won, through its affiliates around the world.
Dong-A ST is expanding its research and development pipeline to include obesity treatments, MASH treatments, dementia treatments, and anticancer drugs, with the goal of developing first-in-class new drugs and best-in-class new drugs in the class. are focusing on
Dong-A ST is particularly focused on developing obesity treatments. The GLP-1 series of obesity treatments, which are currently causing a craze in the global market, eliminates hunger by suppressing appetite and has a weight loss effect.
Dong-A ST is developing an advanced obesity treatment that goes beyond its appetite suppressing effect and increases basal metabolic rate.
GLP-1 series obesity treatment drugs produce an appetite suppressant effect by secreting GLP-1, which is involved in appetite control, causing the brain to feel full. DA-1726, an obesity treatment drug currently under development, not only suppresses appetite through GLP-1 activation, but also increases basal metabolic rate by activating the glucagon receptor, which is involved in increasing basal metabolic rate.
If your basal metabolic rate is high, you expend energy easily, so even if you eat the same amount, you consume more energy and gain less weight than people with a low basal metabolic rate.
DA-1726 showed excellent weight loss effects in an obese animal model despite food intake similar to that of the GL-1 analog semaglutide obesity treatment. Above all, a similar weight loss effect was confirmed despite consuming more food compared to the GLP-1, GIP dual agonist ‘Tirzepatide’, an obesity treatment drug. In addition, more weight was lost when people took more than the tirzepatide-based obesity treatment or when they took it similarly to the semaglutide-based obesity treatment.
Dong-A ST is conducting a global phase 1 clinical trial of DA-1726 through its subsidiary Neurobo Pharmaceuticals.
The global phase 1 clinical trial is being conducted in two parts. Part 1 single dose escalation trial was conducted as a single administration test of DA-1726 or placebo, and excellent safety and tolerability were confirmed on the 2nd. Part 2, a multiple dose escalation trial, will be conducted as a repeated administration trial of DA-1726 or placebo, and clinical results are scheduled to be released in the first quarter of 2025.
Dong-A ST is also challenging the metabolic disorder-related steatohepatitis (MASH) treatment market.
There was no treatment for MASH due to the complex cause of the disease, but in March, the U.S. Food and Drug Administration (FDA) approved the use of ‘Rezdipra’, a MASH treatment drug from Madrigal Pharmaceuticals.
The first treatment for MASH has been released, but as the MASH treatment market is expected to continue to grow, the demand for more advanced treatments is expected to increase.
DA-1241, which Donga ST is developing as a MASH treatment, is a first-in-class new drug with a GPR119 agonist mechanism, and the possibility of developing a MASH treatment has been confirmed in preclinical trials. After DA-1241 administration, improvement effects on liver cirrhosis, inflammation, fibrosis, lipid metabolism, and glucose control were confirmed.
Dong-A ST began developing MASH treatment through Neurobo Pharmaceuticals. In May of last year, the global phase 2 clinical trial of DA-1241 was approved by the U.S. FDA, and in September of last year, part 1 of the phase 2 clinical trial was initiated. In January of this year, part 2 of the phase 2 clinical trial was initiated.
The company plans to complete Parts 1 and 2 of the DA-1241 global phase 2 clinical trial in the second half of this year.
Dong-A ST is also focusing on developing treatments for dementia, which have a high unmet medical need. DA-7503, a tau-targeting dementia treatment, is a first-in-class new drug candidate being developed as a treatment for Alzheimer’s disease and primary tauopathies (frontotemporal dementia, progressive supranuclear palsy).
Tau is a protein that stabilizes the structure of nerve cells by binding to the microtubules of nerve cells. In pathological situations such as Alzheimer’s disease, modified tau is separated from microtubules and forms neurotoxic tau oligomers and aggregates.
DA-7503 is a low-molecular-weight compound that selectively acts on isolated and modified tau to inhibit oligomer formation and intracellular accumulation. Phase 1 clinical trials were approved by the Ministry of Food and Drug Safety in April 2024, and domestic phase 1 clinical trials began in May 2024.
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