Daewoong Pharmaceutical Publishes Results of First Clinical Study of SGLT-2 Inhibitor ‘Enavogliflozin’ for Canine Diabetes

SEOUL, South Korea, June 1, 2021 /PRNewswire/ --Daewoong Pharmaceutical Co., Ltd. (CEO Sengho Jeon) announced that the results of an investigator-initiated clinical study on the effect of Enavogliflozin, originally developed as Type II Diabetes Treatment for humans, on treating canine diabetes were published online by the Korean Society of Veterinary Science on May 27.

This study was conducted by five institutions, including the research team of Prof. Hwa-Young Yoon at the College of Veterinary Medicine of Seoul National University to evaluate the drug’s effect on controlling blood glucose levels and safety for dogs that cannot control blood glucose levels adequately with insulin injection. Similar to type I diabetes in humans, canine diabetes is caused by the failure of the pancreas to produce enough insulin, therefore the main treatment is giving insulin by daily injection.

In the study, researchers compared fructosamine, fasting glucose, and insulin dose changes in a group treated with insulin and Enavogliflozin once daily for eight weeks and the other group once every three days to evaluate its effect on controlling glucose and additionally observed changes in weight and blood pressure. Fructosamine indicates the mean blood glucose for two to three weeks, and diabetes is diagnosed if it increases above the normal range.

The results showed that the fructosamine level decreased 20% in the once daily group and 15% in the once every three days group, and a blood glucose lowering effect was confirmed statistically significantly in both groups. Insulin dose changes decreased 25% in the once daily group and 15% in the once every three days group, and statistical significance was confirmed in the once daily group.

The fasting glucose level decreased in both groups but there was no statistically significant difference. Weight decreased 5% in the once daily group and 2% in the once every three days group, and blood pressure decreased 20 mmHg in the once daily group and confirmed statistical significance. Furthermore, the treatment of Enavogliflozin resulted in no serious adverse event, such as diabetic ketoacidosis or severe hypoglycemia.

“With this study, we confirmed the effect of Enavogliflozin administered with insulin on treating diabetes for domestic animals, including canines,” said Ju-Hyun An, a doctor at the College of Veterinaty Medicine of Seoul National University at his presentation. “When administered once daily, it showed a better therapeutic effect. As no serious adverse event was found in both groups, its safety was also confirmed.”

Daewoong Pharmaceutical CEO Sengho Jeon said, “With this investigator-initiated study, we confirmed the possibility for the first time that Enavogliflozin helped companion animals to control blood glucose levels. As there is no oral medication for canine diabetes for companion animals other than insulin injections, a drug developed for animals is expected to become a new treatment option.”

As of 2019, the number of households raising domestic animals is 5.91 million (26.4%), and the Korean domestic animal market is expected to grow up to KRW 6 trillion by 2027. While diabetes occurs to 1 in 300 dogs and 1 in 200 cats, there is no oral drug to treat diabetes in animals, and it is known that most are treated with insulin injections.

Enavogliflozin currently being developed by Daewoong Pharmaceutical is an oral type II diabetes treatment. Clinical studies are being conducted for the administration of Enavogliflozin alone, with metformin, in triple drug therapy with metformin and a DPP-4 inhibitor. The company is developing Enavogliflozin as a best-in-class drug and aims to launch it in Korea by 2023.

About Daewoong Pharmaceutical. Co., Ltd.

(https://www.daewoong.co.kr/en)

Daewoong Pharmaceutical. is a global healthcare corporation founded in 1945 with the belief to ‘create good medicine to protect the health of the people and create a healthy society.’ Major business areas are hospital prescription drug (ETC) sector, over-the-counter medicine (OTC) sector, exportation of finished products and raw material medicine sector, and consignment production sector. Daewoong continues to invest more than 10% of its sales in R&D every year, focusing on developing gastrointestinal(GI), endocrine, orphan and stemcell based therapeutics.

For further information, please contact:

Cheolheon Park (chpark049@daewoong.co.kr), Daewoong PR manager

Forward-looking Statements

The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,” “expects,” “intends,” “may,” “will,” or “should” and include statements Daewoong(the company, we) makes concerning its business and financials.

outlook and related plans; the therapeutic potential of its product candidates; the intended results of its strategy and the company, and its collaboration partners’, advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and expected data readouts; the design of future clinical trials and the timing and outcome of regulatory filings and regulatory approvals. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The company’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including the effects of the COVID-19 pandemic, our expectations regarding its the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities and regulatory approval requirements; our reliance on collaborations with third parties; estimating the commercial potential of our product candidates; our ability to obtain and maintain protection of intellectual property for its technologies and drugs; our limited operating history; and our ability to obtain additional funding for operations and to complete the development and commercialization of its product candidates. A further list and description of these risks, uncertainties and other risks can be found in Korea Stock Exchange(KRX) filings and reports, including in our most recent annual report as well as subsequent filings and reports filed by the company with the KRX. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. We undertake no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by Korean law and regulations.

View original content:http://www.prnewswire.com/news-releases/daewoong-pharmaceutical-publishes-results-of-first-clinical-study-of-sglt-2-inhibitor-enavogliflozin-for-canine-diabetes-301302769.html

SOURCE Daewoong Pharmaceutical Co., Ltd