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
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

Visa’s Mission to Digitally Enable Small Businesses Gains Momentum Across Europe1.3.2021 10:00:00 CETPress release

Visa (NYSE: V) today announced more than 100 partners across Europe have joined the Where You Shop Matters initiative to help small business owners build digital capabilities and continue serving their communities. More than two million small firms across Europe have received support since the launch of the program in summer 2020. The announcement marks a major milestone in Visa’s commitment to help eight million small and medium sized businesses (SMBs) in Europe – and 50 million globally - to get online, adapt and future proof their business. Across Europe, Covid-19 continues to have a devastating impact on small businesses. Research conducted by Visa revealed that 65% of small businesses are concerned about the future of their business.1 With many having to operate under restrictions and lockdowns, small businesses are increasingly moving their operations online and embracing digital payments. Visa data shows that over 10 countries in Europe have seen a 20% increase in online sales a

Effissimo Releases Presentation Explaining Proposal to Appoint Independent Investigators at Toshiba1.3.2021 08:00:00 CETPress release

Effissimo Capital Management (“Effissimo”), the largest shareholder of Toshiba Corporation (“Toshiba”) (TYO:6502) through the funds it manages, today released a presentation explaining the reasons behind its proposal for an independent investigation into reported irregularities surrounding Toshiba’s July 2020 Annual General Meeting of Shareholders (“AGM”). Effissimo’s proposal will be voted on by Toshiba’s shareholders at an extraordinary shareholders meeting scheduled for March 18, 2021. The full proposal in English can be found here. Supplementing its letter to shareholders dated February 24, 2021, Effissimo’s presentation explains its proposal for an independent investigation into the irregular handling of shareholder voting and shareholder pressure at the closely contested AGM, which Toshiba’s conflicted Audit Committee’s self-audit fails to address. The presentation provides data showing discrepancies in the claimed delivery times of mailed ballots said by Toshiba’s vote tabulator

Mobidiag Receives CE-IVD Marking for Amplidiag ® RESP-4 for Simultaneous Detection of COVID-19, Flu A, Flu B and RSV1.3.2021 07:00:00 CETPress release

Mobidiag Ltd. today announces that it has received CE-IVD marking for its https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fmobidiag.com%2Fproducts%2Famplidiag%2F%23ad-resp-4&esheet=52387757&newsitemid=20210228005031&lan=en-US&anchor=Amplidiag%26%23174%3B+RESP-4&index=1&md5=0cd23e123f09386349b0cce93993cf54 Amplidiag® RESP-4 molecular diagnostic test for the rapid and simultaneous detection of some of the most prevalent respiratory viruses: SARS-CoV-2 (responsible for COVID-19 infection), Influenza A, Influenza B and RSV. These viruses present similar symptoms, making it difficult for physicians to determine accurately which virus a patient has. The https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fmobidiag.com%2Fproducts%2Famplidiag%2F%23ad-resp-4&esheet=52387757&newsitemid=20210228005031&lan=en-US&anchor=Amplidiag%26%23174%3B+RESP-4&index=2&md5=464a0549cf8a17c939d070d2af83d1a7 Amplidiag® RESP-4 assay can rapidly and simultaneously determine an accurate

CLH Evolves to Exolum, the Company’s New Global Brand1.3.2021 06:00:00 CETPress release

Exolum is the new brand name chosen by the CLH Group from now on to face its ambitious objectives for the future, focused on adapting its business to decarbonisation and the energytransition, the digitalisation of its activities and the fight against climatechange. This rebranding is due to the need to adapt to the new environment and to transform the company itself which, in addition to carrying out oil product storage and transport activities in Spain, has embarked on an international growth process and is now present in 7 othercountries. The group has expanded its activity to the storage, management and transportation of liquid products, especially chemical products, operating in new sectors, such as eco-fuels, the circulareconomy and the development of new energyvectors. The new name, simple but modern, shows a spirit where innovation is the key. The Exolum brand was originally devised as the CLH Group subsidiary dedicated to entrepreneurship and innovation. However, after several

CGTN: What Are Generations of Chinese Communists Striving For?27.2.2021 16:36:00 CETPress release

The Communist Party of China (CPC), the ruling party of the world's most populous nation and the second largest economy, is turning 100 this year. What has been motivating the CPC to fight against one challenge after another over the past century? This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210227005021/en/ "The original aspiration and the mission of Chinese Communists is to seek happiness for the Chinese people and rejuvenation for the Chinese nation," General Secretary Xi Jinping of the CPC Central Committee said in his report to the 19th CPC National Congress in October 2017. "This founding aspiration, this mission, is what inspires the Chinese Communists to advance," Xi said. Self-discipline, selflessness In March 2018, Xi, also the Chinese president, further explained the cause pursued by the CPC with a quote from an ancient poem: "A virtuous person is as sharp-sighted as a clear mirror hanging high, a selfless perso

Colicity Inc. Announces Closing of $345 Million Initial Public Offering26.2.2021 23:00:00 CETPress release

Colicity Inc. (the “Company”) announced the closing today of its initial public offering of 34,500,000 units, including the underwriters’ exercise of their full over-allotment option for 4,500,000 units, at a price of $10.00 per unit. The units are listed on the NASDAQ Stock Market (NASDAQ) and began trading under the ticker symbol “COLIU” on February 24, 2021. Each unit consists of one Class A share and one-fifth of one redeemable warrant, with each whole warrant exercisable to purchase one Class A share at a price of $11.50 per share. Only whole warrants will be exercisable. Once the securities comprising the units begin separate trading, the Class A shares and warrants are expected to be listed on the NASDAQ under the symbols “COLI” and “COLIW,” respectively. Colicity Inc. is a blank check company formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses. The Company int

C3 AI and Baker Hughes to Provide Enterprise AI Solutions to Accelerate PETRONAS Digital Transformation Program26.2.2021 15:00:00 CETPress release

C3 AI (NYSE: AI) and Baker Hughes today announced an artificial intelligence (AI) collaboration with PETRONAS, a global energy and solutions company from Malaysia, to apply BakerHughesC3.ai (BHC3) technology across PETRONAS’s strategic digital transformation programs. As the custodian of Malaysia's national oil and gas resources, PETRONAS runs an extensive digital transformation program across energy operations to extract value from data. The adoption of AI as part of its overall program for improved oil and gas productivity, asset integrity, and safety supports PETRONAS’s commitment to provide clean, efficient energy solutions by harnessing the power of technology. PETRONAS will work with energy technology, data science, and AI experts at Baker Hughes and C3 AI to collaborate on projects focused on improved reliability of energy assets in critical operations. Utilizing Microsoft Azure, PETRONAS will deploy the BHC3™ Reliability application to further improve maintenance programs for g