Synergy Innovation's subsidiary Neurobiogen announced on the 19th that it has successfully completed Phase 1 clinical trials of KDS2010, a newly developed novel drug candidate that did not previously exist.
They explained that this marks a step forward in the development potential of an innovative oral treatment that surpasses existing therapies worldwide for severe dementia and obesity treatment.
At the recent clinical results briefing, Neurobiogen's self-developed drug candidate KDS2010 was introduced as an innovative treatment targeting the MAO-B enzyme, which completely breaks the incomplete paradigms of existing GLP-1 target class obesity treatments and amyloid-beta target antibody class dementia treatments. It is a novel concept drug capable of fundamentally treating dementia and obesity.
Unlike other existing treatments, KDS2010 does not easily induce drug resistance and exhibits excellent efficacy with over 10,000 times selectivity for its drug target, the MAO-B enzyme. It is described as a groundbreaking therapeutic substance that causes no serious side effects or drug toxicity even with long-term use.
Moreover, while other existing treatments show reduced efficacy after two weeks due to drug resistance, this drug maintains very high efficacy after 2 and 4 weeks of administration. It is a compound with excellent BBB (blood-brain barrier) permeability, making it a highly competitive drug candidate compared to any existing drugs.
Neurobiogen conducted a global-level Phase 1 clinical trial in Korea involving 88 healthy Korean and Caucasian subjects to assess the drug safety and tolerability of KDS2010, and announced that the trial was very successfully completed, marking the final conclusion of Phase 1.
The company stated that the Phase 1 results showed no side effects or tolerability issues in both Korean and Caucasian healthy subjects treated with KDS2010, and reliable pharmacokinetic/pharmacodynamic data were obtained, preparing the way to enter global Phase 2 clinical trials covering both Korea and the United States.
Additionally, at the briefing, Neurobiogen demonstrated the superiority of KDS2010 by presenting comparative research results on obesity treatment efficacy against existing GLP-1 target drugs, Wegovy (Semaglutide) and Zepbound (Tirzepatide), showing that KDS2010 far exceeds the efficacy of existing GLP-1 agonists.
Currently, existing GLP-1 class obesity treatments such as Novo Nordisk's Wegovy and Eli Lilly's Zepbound have limitations, including insufficient weight loss effects relative to their high prices and rapid weight gain reported upon discontinuation, making long-term administration essential.
Furthermore, due to uncertain or multiple treatment mechanisms and gastrointestinal side effects and resistance associated with these drugs, serious appetite suppression and risks of severe depression and suicidal impulses cannot be completely ruled out.
Therefore, amid the urgent need to develop fundamentally new treatments that overcome these limitations, the study results indicate that KDS2010, a new paradigm drug targeting the MAO-B enzyme, shows potential and promise as a groundbreaking alternative for obesity treatment.
A Neurobiogen representative stated, “We are preparing to conduct global Phase 2 clinical trials targeting obesity and dementia patients in Korea and the United States, while simultaneously pursuing technology export and joint development with overseas global pharmaceutical companies. Additionally, through the development of other next-generation novel drug candidates, we are accelerating the development of fundamental treatments for diseases with high unmet medical needs beyond dementia and obesity, including non-alcoholic steatohepatitis (NASH), inflammatory bowel disease (IBD), and rare neurodegenerative diseases such as ALS and MS.”
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