Business Wire

GNT Pharma’s GedaCure® Approved for the Treatment of Dogs With Cognitive Dysfunction Syndrome

Share

GNT Pharma today announced the Korea Animal and Plant Quarantine Agency (APQA) has approved the New Drug Application for GedaCure®, a chewable tablet of crisdesalazine, for the treatment of dogs with cognitive dysfunction syndrome (CDS) that suffer from disorientation, altered interactions with family, sleep-wake cycle disturbance, house soiling and changes in activity with aging.

GedaCure® is the world’s first multi-target neuroprotection drug for canine cognitive dysfunction syndrome. It is expected to improve the quality of life of aged dogs with CDS and their owners. GNT Pharma plans to launch GedaCure® in South Korea and will push ahead in earnest to advance globally for dogs and their family who suffer from CDS.

Like Alzheimer’s disease (AD), canine CDS is an age-related progressive neurodegenerative disease with a cognitive and behavioral deficit that is accompanied by beta amyloid precipitation, pathological tau, and neuronal death. The prevalence of senior dogs with CDS has been rapidly increasing with the extended lifespan, however, there is no cure for the disease.

Crisdesalazine prevents oxidative stress as a spin trapping agent and inflammation as an inhibitor of microsomal prostaglandin E synthase-1 (mPGES-1), inducible enzymes essential for inflammatory PGE2 production. Crisdesalazine showed considerable effects in 3-D culture and animal models of Alzheimer’s disease in reducing neuronal death, tauopathy, and amyloid plaques to some extent which are pathological hallmarks of Alzheimer’s disease.

In a pilot clinical trial for canine CDS, all 6 companion dogs with CDS that received daily oral administration of 10 mg/kg crisdesalazine for 8 weeks showed remarkable symptomatic relief. Even in 4 weeks after administration of crisdesalazine, the dogs re-recognized and wagged their tails to their owners, slept well in the night, and revealed improved activity.

GNT Pharma conducted a double-blind, randomized, placebo-controlled phase III SMART trial of crisdesalazine for 48 companion dogs with CDS at 6 animal hospitals including Seoul National University Animal Hospital. All dogs were diagnosed as CDS according to canine cognitive dysfunction rating scale (CCDR score: 0-39 = normal, 40-49 = at risk, 50-80 = CDS). Baseline scores of CCDR before drug treatment were 61.7 ± 2.8 for the placebo group and 62.2 ± 2.3 for the crisdesalazine group. CCDR scores were 60.7 ± 2.7 and 65.0 ± 3.9 after 4-week and 8-week treatment with placebo. CCDR scores were reduced to 43.0 ± 2.9 and 42.1 ± 4.0 after 4-week and 8-week treatment with 5 mg/kg crisdesalazine, demonstrating significant beneficial effects of crisdesalazine vs placebo (p<0.0001). Similar beneficial effects were observed in companion dogs with CDS treated with 10 mg/kg crisdesalazine. Such beneficial effects lasted over at least 4 weeks after discontinuing 8-week treatment with crisdesalazine. Drug-related adverse events were not observed.

“Administration of crisdesalazine significantly and noticeably improved cognitive function and behavioral activity without causing adverse effects in dogs with CDS that participated in the SMART trial. With rapidly increasing population of aged dogs, CCDS has been one of therapeutic areas with the highest unmet medical need. In light of proven efficacy and safety, crisdesalazine is expected to improve the quality of life of aged dogs with CDS and their owners,” said Hwa-Young Youn, D.V.M. and Ph.D., Professor of Veterinary Medicine at Seoul National University, Principal Investigator of SMART trial.

“We are excited to receive a new drug approval for the treatment of old dogs with CDS. The novel dual antioxidant and anti-inflammatory action of crisdesalazine, which was shown to reduce amyloid plaque, tauopathy, and neurodegeneration in various cell culture and animal models, has the potential to revolutionize how we care for CDS,” said Byoung Joo Gwag, Ph.D., GNT Pharma’s President and CEO, Adjunct Professor of Biological Sciences at Yonsei University. “Crisdesalazine, the first multi-target drug proven and approved for CDS featuring brain pathology similar to AD, gives hope for better treatment of AD patients. We plan to initiate a pivotal clinical trial of crisdesalazine for patients with mild to moderate AD this year.”

Contact information

GNT Pharma
COO, GNT Animal Health Care
Dr. Jinhwan Lee, +82-31-8005-9910 (EXT.217)
jhlee@gntpharma.com
Fax. +82-31-8005-9916

About Business Wire

Business Wire
Business Wire



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

PMI Launches Free, Online Course and Tool Kit to Help Changemakers Jumpstart Project Success in Just 45 Minutes2.3.2021 17:00:00 CETPress release

Project Management Institute (PMI), the world's leading association for project professionals and changemakers, today announced the launch of KICKOFF, a new, free online course and tool kit to help introduce anyone doing project-based work to the best practices and tools needed to effectively manage projects from ideation to execution. Much of the working world revolves around projects, which have become more complex than ever due to global Megatrends, including COVID-19, climate change, and more. The need for changemakers, regardless of industry or position level, to be well-versed in the principles of project management in order to help drive results, has never been greater. KICKOFF is the ideal solution for those who are new to doing project-based work and would benefit from learning project management skills to help successfully navigate the process from idea to launch and execution. The course is packed with digestible content, downloadable templates, a glossary of key terms, and

Xendit Raises US$64.6 Million Series B Led by Accel to Scale Its Digital Payments Infrastructure Ushering in a New Era of Economic Security and Reliability in Southeast Asia2.3.2021 16:08:00 CETPress release

Xendit, the fastest growing digital payments infrastructure for Southeast Asia, announces it has raised US$64.6 million in a Series B round led by Accel to deliver more secure and reliable economic success in the region. Altogether, the company has raised $88 million in funding. Amid Southeast Asia’s rapid digital transformation, Xendit is quickly bolstering businesses of all sizes, processing more than 65 million transactions with US$6.5 billion in payment value annually. “Southeast Asia is a massively complex region, with Indonesia having 17,000 different islands alone—not to mention the region’s regulatory and technological challenges. Trying to build the businesses of tomorrow on yesterday's infrastructure is holding Southeast Asia’s businesses back,” said Moses Lo, CEO and Co-Founder. “This latest investment will enable Xendit to scale our digital payments infrastructure quickly and provide millions of small and medium-sized businesses across Southeast Asia with an on-ramp to the

Andersen Global Initiates Expansion Into Bermuda2.3.2021 15:30:00 CETPress release

Andersen Global establishes a presence in Bermuda through a Collaboration Agreement with Hamilton-based law firm Alexanders, Barristers & Attorneys, adding additional coverage to its global platform. Founded in 2005, Alexanders, Barristers & Attorneys is a law firm with a primary focus on corporate and trust laws. The firm provides services to corporate clients and high net worth individuals, which complements the U.S. member firm’s practice and the global organization’s ability to meet clients’ cross-border needs in Australia, Canada, Africa, the United Kingdom and globally through its member firms and collaborating firms. Additionally, the firm specializes in intellectual property registration and law, investment fund formation and law, insurance company formation and law, and admiralty and maritime law. “Our top priority is delivering best-in-class solutions to our clients locally and abroad, and our ability to do that has been and continues to be a key contributor to our firm’s suc

BORN Expands With Alkeon B2B Market Network Platform Transforming Commercial Models, Starting With the Trade Show Industry2.3.2021 15:12:00 CETPress release

BORN, announces the expansion of innovative B2B subsidiary Alkeon, the world's first global SaaS market-network combining content, community, and commerce to connect buyers and sellers through a best-in-class platform, powered by machine learning. The 2020 pandemic generated a tremendous and immediate need for companies of all categories to pivot at a moment’s notice, with over 10,000 global trade shows completely upended due to cancellations of physical events. BORN, a purpose driven lifestyle company dedicated to reimagining the discovery, transaction and connection of the B2B and B2C communities, found an opportune moment to quickly scale and enhance their technology solutions. The company formally established Alkeon, an enterprise dedicated to supporting the needs of companies who are adapting to the current and future landscapes and need the right partner to support them through the process. Combining aesthetic and function to create designed technology, Alkeon is a market-network

South Africa and France Lead the Way in Public and Private Sector Gender Diversity, Latest Research by Kearney Reveals2.3.2021 15:00:00 CETPress release

The latest ‘Gender Equality Report’ from Kearney has revealed progress in the representation of women in both public and private sectors, but the figures still don’t show parity. Ahead of International Women’s Day, the analysis provides insight into the progress of gender diversity in private and public sectors across nine countries – the United States, United Kingdom, Australia, India, France, Spain, Germany, South Africa and Singapore. The annual report revealed that France was number one for representation in the private sector with women comprising nearly 44% (43.8%) of board members on average, however only 2% of these women held top board positions. The UK (36%) and Australia (34%) also scored highly for representation of women on boards. The average for board level representation of women is 29.9% - not even one in three. % Female board level representation by country France 43.8% UK 36.0% Australia 34.0% Germany 32.5% Spain 29.8% US 29.8% South Africa 28.5% Singapore 17.3% Indi

beqom Announces beqom FlexFS, a Compensation Management Solution Dedicated to Financial Services2.3.2021 15:00:00 CETPress release

beqom, provider of cloud-based compensation management software, today announced the launch of beqom FlexFS, a solution designed specifically for the financial services (FS) industry. “Financial services compensation is unique,” says Vismay Gada, Head of North America and Global Financial Services at beqom. “First there is a broad spectrum of financial services companies—retail banking, investment banking, asset management, hedge funds, insurance, private equity, and so on. That means that rewards and deferred compensation structures have many specialized needs across the industry. And, companies in each segment have to deal with different regulations that impact compensation treatment, which has its own unique challenges. Our FS customers have come to us to help them address complex compensation requirements that are beyond the scope of what their core HR systems can handle.” “We usually see a lot of our FS companies use Excel or Access databases to augment the limitations of core HR

Craig Lipset is Appointed Chairman of the Trialbee Industry Advisory Board2.3.2021 15:00:00 CETPress release

Trialbee, the leading global data and technology platform provider for patient matching and enrollment in clinical trials, today announced the appointment of Craig Lipset as Chairman of the Trialbee Industry Advisory Board. Craig is a recognized visionary leader who has spent his career dedicated to transforming some of the most challenging issues in clinical research through new innovations. Craig is the former Head of Clinical Innovation and Venture Partner at Pfizer and a distinguished leader at the forefront of innovation in clinical research and medicine development. Most recently Craig cofounded and co-Chairs the Decentralized Trials & Research Alliance (DTRA), which roughly 100 leading life science organizations have joined the first few months since it was established. The core mission of DTRA is making clinical trial participation widely accessible by advancing policies, research practices and new technologies in decentralized clinical research. A significant barrier to patien

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