GNT Pharma Files Two PCT Patent Applications for Alzheimer’s Candidate Drug ‘Crisdesalazine’
GNT Pharma Files Two PCT Patent Applications for Alzheimer’s Candidate Drug ‘Crisdesalazine’
  • Hyun Duk Yang
  • 승인 2021.12.13 09:16
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Ongoing its phase 1b study
In preparation for the IPO
Photo: GNT Pharma

GNT Pharma (hereafter ‘GNT’ for short) headquartered in Yongin, South Korea, a biotechnology company developing innovative drugs for the treatment of neurological diseases including Alzheimer’s disease (AD), announced on December 7th that it had applied for two international patent applications under the PCT (Patent Cooperation Treaty) for ‘crisdesalazine’, an innovative candidate drug for AD. These two patents will cover the methods of manufacture and the crystalline formulations of crisdesalazine.

The PCT is an international patent law treaty which provides the unified procedures for applications to protect patent rights in its member countries, thus enabling the near global patent coverage. However, a PCT application itself does not grant a patent and needs to be proceeded with the step of entering into national phase for the grant of patents.

In collaboration with its Chinese partner ‘Apeloa Pharmaceutical (Apeloa)’, GNT has developed the manufacturing methods to reduce the impurities generated in the process of synthesis and to improve the quality and yields of crisdesalazine.

In addition, GNT has completed its applications for patents on the manufacturing methods and two high-purity crystalline formulations of crisdesalazine which have physicochemical properties suitable for the treatment and prevention of nervous system disorders.

According to the signed agreement with Apeloa, two companies jointly applied for the patents on the manufacturing methods and the crystalline formulations of crisdesalazine to China in December 2020, while GNT applied alone for the international patents to countries other than China this time.

GNT’s innovative ‘crisdesalazine’ has anti-inflammatory effects by inhibiting the overexpressed microsomal prostaglandin E synthase-1 (mPGES-1), an inducible enzyme that synthesizes proinflammatory PGE2 in the AD brains. Crisdesalazine also has anti-oxidant effects by scavenging the Reactive Oxygen Species (ROS). In the AD animal models, crisdesalazine showed anti-amyloid and anti-tau effects as well.

Originally, GNT developed ‘crisdesalazine (also known as AAD-2004)’ for the treatment of canine cognitive dysfunction syndrome (or dementia in dogs) and commercialized it successfully under the product name of ‘ZedaCure’ in February this year.

Based on the findings that canine dementia is an age-related neurodegenerative disease with the brain pathologies similar to those in human AD and that crisdesalazine showed the therapeutic efficacy in canine dementia, GNT extrapolated that crisdesalazine may give hope for the treatment of human AD.

The phase 1a clinical study of crisdesalazine in 32 healthy subjects was successfully completed in 2017, and the phase 1b clinical trial in 40 healthy individuals is currently ongoing. Furthermore, two phase 2 studies are in preparation and expected to initiate late next year.

In parallel with these clinical trials, GNT is also preparing for the Initial Public Offering (IPO) since July this year.

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