Business Wire

LG Chem Life Sciences and TransThera Biosciences Announce FDA Clearance of IND for TT-01025, a SSAO/VAP-1 Inhibitor

Share

LG Chem Life Sciences (“LG Chem”), a division of LG Chem, and TransThera Biosciences Co. Ltd. (“TransThera”), a clinical-stage biotechnology company based in Nanjing, China, announced today that U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for TT-01025, a novel SSAO/VAP-1 inhibitor for the treatment of non-alcoholic steatohepatitis (NASH) and other inflammatory diseases.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201201006171/en/

LG Chem will initiate the Phase 1 clinical trial at PPD Las Vegas Clinical Research Unit in Las Vegas, NV, United States to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TT-01025 in healthy subjects. The trial is expected to be initiated in the first quarter of 2021.

“As liver manifestation of a metabolic disorder, NASH is a potentially life threatening condition which increases cardiovascular risk and can lead to cirrhosis with the need for liver transplantation,” said Dr. Manfred Stapff, President of LG Chem Life Sciences Innovation Center, Cambridge, MA. “Since there is no specific treatment for NASH approved so far, we are proud to contribute to the clinical development of TT-01025 to address a significant medical need.”

“The IND clearance for TT-01025 marks an important milestone for its global development. We acknowledge the LG Chem and TransThera teams for their commitment, seamless collaboration and strong team spirit during the IND preparation,” commented Dr. Jennifer Sheng, Vice President of Biology at TransThera. “We look forward to the initiation of Phase 1 trial of TT-01025 in the coming months. We believe that the strong global clinical and commercial capabilities of LG Chem team will accelerate the development of TT-01025 and bring this promising therapy to NASH patients with high unmet medical needs.”

LG Chem reached an exclusive license agreement with TransThera Biosciences on August 17th, 2020 to research, develop, manufacture and commercialize TT-01025 in global region except Greater China and Japan.

About TT-01025

TT-01025 is a highly selective oral small molecule inhibitor of Semicarbazide-Sensitive Amine Oxidase/Vascular Adhesion Protein-1 (SSAO/VAP-1) that has shown promising efficacy in pre-clinical investigation in non-alcoholic steatohepatitis (NASH). The inhibition of SSAO/VAP-1 blocks oxidative conversion and leucocyte transmigration during inflammation processes and exhibits therapeutic potential across a range of chronic inflammatory conditions, including NASH.

About NASH

NASH is a chronic and progressive liver disease characterized by fat accumulation and inflammation in the liver, which can lead to fibrosis and impaired liver function. The disease can be silent for a long period of time, but once it accelerates, severe damage and liver cirrhosis can occur, which can significantly impact liver function or can even result in liver failure or liver cancer. There are as yet no globally approved drugs for the indication.

About LG Chem Life Sciences

LG Chem Life Sciences is a business division within LG Chem, engaged in the development, manufacturing, as well as commercializing pharmaceutical products globally. LG Chem Life Sciences seeks to expand and make global presence by focusing on key core therapeutic areas of Immunology, Oncology, and Metabolic Diseases (specifically, diabetes and related metabolic diseases). To achieve such, its strategy is to actively pursue global collaboration encompassing from asset-centric to strategic investment and collaboration.

About TransThera Biosciences

TransThera Biosciences is a clinical-stage biotechnology company dedicated to developing innovative therapeutics to target diseases with major unmet medical needs via internal research platform and open innovation. TransThera's current portfolio covers therapeutic areas such as oncology, cardiovascular, and inflammatory diseases. For more information, please visit www.transtherabio.com.

Contact information

Media (Jiin Chung): media.cbl@lgchem.com
General Inquiries: contact.cbl@lgchem.com
Partners: partners.cbl@lgchem.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Xsolla Launches New Mobile Game Commerce Solution to Help Developers Expand Their Mobile Business26.1.2021 18:01:00 EETPress release

Xsolla, the video game commerce company powered by Transaction Engine and Business Engine to help developers and publishers market, sell, connect and optimize their games globally, today launched its Mobile Game Commerce solution designed to level up and manage mobile games beyond the app stores. Xsolla’s new innovative Mobile Game Commerce solution enables developers to streamline user acquisition, create better ways for players to discover games, simplify the online game commerce experience, build an online player community, expand their global footprint and increase future transaction revenue. Mobile Game Commerce gives developers the tools to successfully operate PC and online versions of their mobile games, and create top-up experiences for players to add virtual currencies to their accounts: Expand onto PC and Online to unlock additional distribution, acquisition and in-game monetization channels for new and existing players. Communicate, better serve and share new offerings with

Andersen Global Expands Coverage in South Africa26.1.2021 17:30:00 EETPress release

Andersen Global enhances its presence in South Africa through a Collaboration Agreement with full-service accounting and tax consulting firm SAB&T Business Consulting (SAB&T), expanding the organization’s coverage to nine additional cities in the country: Centurion, Bloemfontein, Cape Town, Durban, Kimberley, Nelspruit, Polokwane, Port Elizabeth and Rustenburg. Founded in 1994, SAB&T’s team of professionals serves individuals, SMEs and multinationals in various industries including agriculture, education, entertainment, hospitality, manufacturing, retail and technology. “Our firm has developed strong relationships with our clients by providing best-in-class solutions and maintaining the highest standards of professional conduct and expertise since the birth of South Africa’s democracy in 1994,” Chief Operating Officer Fazel Sulaman said. “Our goal is to remain a leading firm by continuing to meet and exceed clients’ expectations. We look forward to working with Andersen Global’s member

Moody’s Analytics CECL Solutions Complete 2020 SOC 1® Examinations26.1.2021 17:00:00 EETPress release

Moody’s Analytics today announced that the ImpairmentStudio™, RiskCalc™, and CMM™ platforms have completed System and Organization Controls (SOC 1) Type 2 examinations under the attestation standards established by the American Institute of Certified Public Accountants. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210126005350/en/ The SOC 1 report examination encompasses policies, operating procedures, and controls related to financial reporting of user entities by an independent auditor, to objectively validate that the service organization meets its declared control objectives. Banks, credit unions, and insurance companies use our ImpairmentStudio solution to automate allowance calculations, analysis, reporting, and workflow. This award-winning solution combines our credit risk data, best-in-class analytics, and impairment accounting expertise, and has been celebrated for its completeness and broad CECL automation capabi

Brightcove Receives Two Technology and Engineering Emmy® Awards26.1.2021 17:00:00 EETPress release

Brightcove Inc. (NASDAQ: BCOV), the global leader in video for business, today announced it is the recipient of two Technology and Engineering Emmy® Awards, awarded by the National Academy of Television Arts & Sciences (NATAS) for excellence in engineering innovation. The recent accolades further solidify Brightcove’s leadership within the industry, most notably as one of the only online video platforms to be recognized for its distinguished video services. Brightcove’s Context Aware Encoding technology was recognized for excellence and engineering creativity in the Development of Perceptual Metrics for Video Encoding Optimization category. The technology enables customers to distribute videos encoded at high visual quality while minimizing network bandwidth and storage costs. Additionally, Brightcove’s Zencoder and Video Cloud products were acknowledged in the Development of Massive Processing Optimized Compression Technologies category. The award distinguishes Brightcove's innovation

PROFIL® Launches New Website26.1.2021 17:00:00 EETPress release

PROFIL®, a PennEngineering® company and leading global manufacturer of mechanically attached fasteners for the automotive market, has announced the launch of a new website, www.profil-global.com . The new website, available in English and German, provides visitors with an enhanced user experience that makes it easy to learn about PROFIL® products, installation methods, and application usage. In addition to its highly intuitive and modern site design, new content features include: Interactive Search – users can search for and filter product information by a variety of features including product type, size, material, application, and fastening method. Cost Calculator – new cost calculator tool determines the potential cost savings gained by using PROFIL® In-Die Mechanically Attached Fasteners (MAF) compared to weld fasteners. Interactive Application Overview – through an animated and interactive vehicle diagram, users can see exactly how and where PROFIL® fasteners are used by applicatio

Orphan Drug Designation Granted to Rezafungin in EU for the Treatment of Invasive Candidiasis26.1.2021 16:00:00 EETPress release

Mundipharma and Cidara Therapeutics today announced that the European Commission (EC) has now adopted the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) recommendation to grant Orphan Drug Designation (ODD) to rezafungin, a novel, once-weekly echinocandin, for the treatment of invasive candidiasis (IC).4 The EMA considers ODD status for medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than five per 10,000 people in the EU.5 It is estimated that IC occurs in around 0.84 per 10,000 people in the EU,6 and mostly affects hospitalised, immunocompromised or critically ill patients.2 IC continues to be an area of significant unmet need, especially for critically ill patients in hospitals and patients with compromised immune systems. Despite a number of available treatments, mortality rates are as high as 40%.3 IC is characterised as a severe, life-threatening systemic Candida infection of the bloods

Software Industry: Nexway™ Reinforces the Customer Experience Capabilities of its Monetize Personalized Growth Platform26.1.2021 16:00:00 EETPress release

Nexway, a leading software and service company for e-commerce and payments, is very excited to launch the latest features on its personalized growth platform Nexway Monetize, moving forward in its mission to expand the online footprint and sales potential of software vendors, games publishers and service providers across 140 countries around the world. In today’s uncertain business environment, the e-commerce and payment leader is looking to leverage its best technologies to offer a seamless purchase experience, helping its clients to remain flexible in their strategic approach to e-commerce. Nexway‘s teams are driving versatility, flexibility, and frictionless features to conquer new markets and expand into vertical sectors linked to customer monetization, subscriptions, and B2B sales management. Nexway also intends to continue growing thanks to its agility, expertise, and high level of the customer purchase experience. "Customer experience is a constantly moving target, changing to m

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom