Shanghai, October 20, 2023 /PRNewswire/ — Shanghai Zhimeng Biopharmaceutical Co., Ltd. (hereinafter referred to as “Zhimeng”) announced its innovative small molecule KCNQ2/3 selective opener for the treatment of amyotrophic lateral sclerosis (ALS) Compound (CB03) obtained orphan drug status and drug designation (ODD) from the US FDA. CB03 is also being developed for other central nervous system diseases, such as refractory epilepsy, major depressive disorder (MDD), etc.
CB03 is a drug candidate independently developed by Zhimeng for the treatment of central nervous system (CNS) diseases such as ALS.A Phase 1 study is currently underway to evaluate the safety, tolerability and pharmacokinetics of CB03 in healthy subjects Australia and the United States. The Phase 1 study is expected to complete dosing phases (single-dose and multiple-dose) by the end of 2023.
“The U.S. FDA’s orphan drug designation for CB03 is an important milestone in its global clinical development for ALS and other central nervous system diseases.“Said Dr. Chen Huanming, President and CEO of ZhimenG. “Since ALS is a very serious disease with insufficient treatment options, we hope that through our unremitting efforts, we can bring safer and more effective drugs to ALS patients around the world as the first indication of CB03.”
About CB03
Research on neurons has shown that neuronal hyperexcitability is one of the important potential causes associated with neurodegenerative and neuropsychiatric central nervous system diseases, including ALS, epilepsy, MDD, neuropathic pain, etc. As the most widely distributed and abundant ion channel, potassium (K+) channel is mainly involved in the regulation of neuronal excitability and the frequency and amplitude of action potential discharges. Therefore, CB03, as a KCNQ2/3 potassium channel opener, has the potential to be a safe and effective therapeutic option for ALS and other CNS designs.Meeting.
as new gGeneration of selective KCNQ2/3 potassium channel openers, CB03 exhibits better chemical and metabolic stability, higher biological/pharmacological activity in vitro and in ALS animal disease models, and ricePharmacokinetics of minerals that can be made into drugstie.Therefore, it is unlikely that CB03 is associated with Other channel pioneers Further clinical development is needed to demonstrate potential benefit in the ALS patient population.
About amyotrophic lateral sclerosis (ALS)
ALS is a neurodegenerative disease that affects nerve cells in the brain and spinal cord. ALS causes a loss of muscle control and can become more severe over time. The exact cause of ALS is unknown, but neuronal hyperexcitability leading to neuronal damage may play an important role in the onset and progression of the disease. A small number (about 10%) of ALS cases are hereditary.
ALS usually begins with muscle twitching, weakness in the arms or legs, difficulty swallowing, or slurred speech. Eventually, ALS affects the control of muscles needed to move, speak, eat, and breathe. Most ALS patients may only survive 3-5 years after diagnosis. There are some drugs approved to treat ALS symptoms or slow the progression of the disease, but there is currently no cure for this deadly disease.
About Zhimeng
Zhimeng is a clinical-stage biopharmaceutical company developing innovative medicines to treat chronic hepatitis B (CHB) and serious neurological diseases where there is an unmet medical need. The company recently announced the successful completion of the Phase Ib clinical trial of its new hepatitis B virus capsid inhibitor canocavir (ZM-H1505R), and has launched Phase II research in June 2022. In addition, the company’s clinical trial application for TLR8 has also been completed.Agonist (CB06) approved by FDA in 2017 December 2021the first phase of research started in USA exist March 2022.
Disclaimer
This press release contains forward-looking statements. Although Zhimeng believes that these forecasts are based on reasonable assumptions, these forward-looking statements are subject to a number of risks and uncertainties, and actual results may differ materially from those anticipated in such forward-looking statements.
For more information, please visit: www.corebiopharma.com
Source: Shanghai Zhimeng Biopharmaceutical Co., Ltd.
