Algernon Pharmaceuticals Receives Notice of Intention to Grant from Chinese Patent Office for Repirinast to Treat NASH and NAFLD

VANCOUVER, British Columbia, Nov. 30, 2023 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF) a Canadian clinical stage pharmaceutical development company, is pleased to announce that it has received a notice of intention to grant from the Chinese Patent Office for patent application No. 112654357 entitled “Compositions and Methods for Treating Non-Alcoholic Steatohepatitis” with NP-251 (Repirinast).

The invention claims treating lobular inflammation and nonalcoholic fatty liver disease (NAFLD), including nonalcoholic steatohepatitis (NASH) and NASH-derived hepatocellular carcinoma, with Repirinast. The base claims of the patent will be valid through 2038, excluding any patent term adjustments or extensions which may provide additional protection. The Company was recently issued patents for Repirinast in NASH from the U.S. and Japan, and has also filed corresponding patent applications in Canada and Europe.

The company previously disclosed that Repirinast, in a widely used STAM mouse model of NASH from SMC Laboratories (Japan):

• Reduced hepatic fibrosis by 57% compared to vehicle (p < 0.0001);
• Reduced the NAFLD score, a composite histopathological measure of inflammation, steatosis and ballooning, by 31% compared to vehicle (3.125 vs 4.5 points, p = 0.059);
• In the same model, telmisartan, a positive control and the standard of care for NASH, reduced fibrosis by 27% (p = 0.014)
  

Repirinast is also the Company’s lead candidate for the treatment of CKD based on data showing it reduced fibrosis by 51% with statistical significance and showed an additive benefit to telmisartan in a unilateral ureteral obstruction (UUO) mouse model. Because patients with NAFLD have a two-fold increased risk of CKD, even when controlling for other comorbidities such as obesity, type 2 diabetes mellitus and insulin resistance, Repirinast is a strong candidate for both indications.

Algernon’s intellectual property strategy for its repurposed drug program includes protecting its compounds by filing patent applications including method of use, dosing and formulations, and for new composition of matter patents based on novel salt forms.

“We are pleased to receive this notice of intent to grant from the Chinese Patent Office,” said Christopher J. Moreau CEO of Algernon Pharmaceuticals. “This will be the first patent granted to the Company in China, and it complements multiple other patents issued in other major world markets as part of our comprehensive global intellectual property strategy.”