Micot Announces First-in-Human Dosing of MT2004 in Phase I Clinical Trial in the U.S.

Recently, Micot Technology Co., Ltd. officially announced that following the U.S. FDA’s approval of its Investigational New Drug (IND) application for MT2004, an independently developed innovative product, the first dose was successfully administered to a healthy volunteer in the United States on March 6 as part of its Phase I clinical trial. The study aims to evaluate the safety, tolerability, and pharmacokinetic profile of MT2004 in healthy subjects using Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) regimens.

MT2004 employs specific chemical modifications to achieve liver targeting and selectively activate the FXR receptor, thereby regulating the expression of genes involved in bile acid metabolism to maintain bile acid homeostasis. MT2004 exerts its hepatotropic effects and is indicated for the treatment of chronic liver diseases, including non-alcoholic steatohepatitis (NASH), primary biliary cholangitis, and portal hypertension.

After prolonged and relentless scientific research, the Micot team has summarized and analyzed extensive preclinical animal experimental data, which demonstrate that MT2004 exhibits excellent performance in reducing NASH pathological scores. The two key liver function transaminases, AST and ALT, show only physiological fluctuations without causing liver injury. Meanwhile, preclinical study data have proven that MT2004 also performs well in reducing hepatic fibrosis, inhibiting the progression of NASH, lowering serum transaminase levels (AST/ALT), and improving liver damage. It is expected that in future clinical applications, MT2004 will provide a novel clinical solution for patients by reducing the incidence of hepatobiliary events.

In this regard, Mr. Wang Bing, Founder and General Manager of Micot, stated that the timely administration of the first dose to a healthy volunteer in the Phase I clinical trial of the MT2004 project amid the current pandemic fully demonstrates the Micot team’s capability and confidence in overcoming challenges and ensuring the smooth progress of the company’s annual overall projects. Micot will continue to adhere to its established strategic objectives, take fulfilling unmet clinical needs as its mission, and persistently innovate and strive for human health and well-being.

Micot Technology Co., Ltd., established in 2007, is a Sino-foreign joint venture innovative drug R&D company with a global outlook. The company is dedicated to the research and development of new molecular entities based on bifunctional and multifunctional specific peptides, striving to become an internationally leading pharmaceutical R&D enterprise in the niche sector of novel peptide drugs and cardiovascular innovative therapeutics. Guided by a strategy of global innovative drug development and driven by its mission to “serve patients and healthcare providers, develop new medicines, save lives, alleviate suffering, improve quality of life, and address unmet clinical needs,” the company focuses on the R&D of new drugs in the fields of cardiovascular diseases, metabolism, and anti-inflammatory and analgesic therapies.

After more than a decade of development, Micot has established a product pipeline comprising 17 new drug candidates, covering five major therapeutic areas: ischemic heart disease, stroke, anticoagulation and antithrombosis, nervous system injury and degeneration, and diabetes. Among these, three candidates have been selected for the National "Major New Drug Creation" Special Project; three have been approved to enter clinical studies by China's CFDA; two have been approved to enter clinical studies by the U.S. FDA; three are undergoing preclinical studies in the United States; and eight are planned for submission to the U.S. FDA for Investigational New Drug (IND) applications as new molecular entities.

Currently, the company’s research base in Xi’an covers a total area of over 3,000 square meters and features fully equipped modern laboratories for new drug research. It is capable of independently conducting new drug design and synthesis, raw material studies, quality control, formulation development, and pharmacological and efficacy studies. The company employs more than 40 staff members, over 60% of whom hold master’s degrees or higher. Meanwhile, the company plans to launch the construction of a new R&D center aligned with its strategic roadmap, as well as a GMP-compliant manufacturing facility capable of meeting commercial production needs following New Drug Application (NDA) approval, both in Suzhou in 2020. Additionally, it intends to establish offices in Beijing, Shanghai, and Boston, USA. Related initiatives are expected to commence in 2020, alongside efforts to enter the capital markets.