Medicilon assists TransThera to obtain the Chinese IND for the VAP-1 inhibitor TT-01025, which has the first human subject in the USA

2021-02-25

Page View：

On February 22, 2021, Nanjing TransThera Biosciences Co., Ltd. (“TransThera”) and the life science company of South Korea’s LG Chem (“LG Chem”) jointly announced the VAP-1 inhibitor TT-01025 (LG0030317) Successfully achieved the first subject administration in the United States. TransThera also announced that the company has completed the submission of an IND clinical trial application for TT-01025 to China’s NMPA.

TT-01025 is a highly selective oral small molecule inhibitor of semicarbazide-sensitive amine oxidase/vascular adhesion protein-1 (SSAO/VAP-1), shown in preclinical studies of non-alcoholic steatohepatitis (NASH) It has a good effect. Inhibition of SSAO/VAP-1 can prevent oxidative transformation and leukocyte migration during inflammation, and shows therapeutic potential in a series of chronic inflammations including NASH. In August 2020, TransThera and LG Chem reached a global exclusive development authorization and cooperation agreement on TT-01025. LG Chem has obtained the exclusive global development and commercialization rights for TT-01025 excluding China and Japan. TransThera will receive a total of 350 million U.S. dollars in down payment, development and commercialization milestone payments, and future product sales commissions. (The information comes from the official website of TransThera)

As a one-stop service CRO from drug discovery to IND declaration, Medicilon was fortunate to be entrusted by TransThera to complete preclinical pharmacokinetics and safety evaluations. The preclinical research team of Medicilon that participated in the drug has sincerely cooperated, worked together, and overcome problems with the drug’s partners in the progress of the project, and made every effort to promote the high-quality and efficient completion of the project.

❖ Medicilon’s pharmacokinetics services

Our Preclinical Pharmacokinetics Department has a number of professionals with rich theoretical knowledge and experimental experience for experiment design, experiment implementation, bioanalysis and data analysis. Our Pharmacokinetics Lab has passed the GLP certification by NMPA. Following the guiding principles of ICH, NMPA and FDA. The lab offers in vivo and in vitro pharmacokinetic tests according to the needs of our clients and provide them with complete sets of pharmacokinetic evaluation and optimization services. Our acclaimed quality data collection and efficient experiment can meet our clients’ needs from early drug discovery to new drug filing.

❖ Medicilon’s drug safety evaluation

Medicilon has a quality management system for drug safety evaluation based on the internationally certified AAALAC quality standard and compliance with international and domestic GLP regulations.
Since 2008, we have continued to meet international standards and completed high-quality GLP safety evaluation services, establishing a long-term brand effect. Medicilon can perform systematic evaluation services covering multiple toxicity endpoints and has internationally recognized pathology studies to support our safety evaluation studies.

ation, Medicilon was fortunate to be entrusted by TransThera to complete preclinical pharmacokinetics and safety evaluations. The preclinical research team of Medicilon that participated in the drug has sincerely cooperated, worked together, and overcome problems with the drug’s partners in the progress of the project, and made every effort to promote the high-quality and efficient completion of the project.

Non-alcoholic steatohepatitis (NASH) is an important health problem that affects hundreds of millions of people worldwide, and it is also a difficult disease to conquer. The initiation of the TT-01025 clinical study is an important milestone for LG Chem, and it also marks another crucial step towards the success of overcoming non-alcoholic steatohepatitis.

Medicilon congratulates the TransThera and LG Chem on the milestone progress, and hopes that TT-01025 will achieve good therapeutic effects in the next clinical trials, and will be available soon, benefiting more patients with non-alcoholic steatohepatitis. At the same time, Medicilon looks forward to helping more innovators in pre-clinical drug development to develop new drugs faster and better to protect human health!

About TransThera

TransThera Biosciences Co., Ltd. is a small molecule new drug creation platform company rooted in China but with an international perspective. TransThera’s strategy is to use technology and business leaders to lead the new generation of teams to transform basic scientific research into small molecule new drug research and development, and continue to innovate and develop companies to solve human health problems. We are committed to the development of a class of new drugs and new technology products that meet international clinical needs. Through independent R&D and international cooperation, we efficiently integrate R&D resources and strive to build the company into a leading international biomedicine company.

About LG Chem

LG Chem is responsible for the development, manufacturing and commercialization of global medicines. LG Chem is committed to expanding its global business in the core therapeutic areas of immunity, tumors and metabolic diseases (especially diabetes and related metabolic diseases). Actively seeking global cooperation centered on products to strategic investment and collaboration is its main strategy to achieve this goal.

About Medicilon

Medicilon (stock code: 688202) was established in 2004 and is headquartered in Shanghai. It is committed to providing a full range of pre-clinical new drug research services for global pharmaceutical companies, research institutions and scientific researchers. Medicilon’s one-stop comprehensive service helps customers accelerate the development of new drugs with strong project management and more efficient and cost-effective R&D services. The services cover the entire process of pre-clinical new drug research in medicine, including drug discovery, pharmaceutical research and clinical trials. Pre-research. Medicilon grows together with high-quality customers at home and abroad, and provides new drug research and development services to more than 700 customers around the world. Medicilon will continue to base itself on a global perspective, consolidate China’s innovation, and contribute to human health!