CDSCO panel opines Paraxel to study either CKD or heart failure in phase IIb trial of AZD9977,Dapagliflozin FDC

This came after global clinical research organization Paraxel presented Phase IIb clinical trial protocol no. D6402C00001, amendment 6 version 7.0 dated 02/02/2022 before the committee.

In relation to Innovation vis-a-vis existing therapeutic option, it is noted that the proposed study is to evaluate the efficacy, safety and tolerability of Oral AZD9977 and Dapagliflozin treatment in patients with heart failure and chronic kidney disease.

In relation to the risk versus benefit to the patients, the proposal claimed that the safety profile of the study drug from preclinical and clinical studies justify the conduct of the trial.

In addition, the proposal further mentioned that the test drug may be alternative treatment option for patients with heart failure and chronic kidney disease.

Various studies reported that AZD9977 is a first-in-class mineralocorticoid receptor (MR) modulator which shows cardio-renal protection despite a mechanism-based reduced liability to cause hyperkalemia.

AZD9977 is a potent, selective, and orally active mineralocorticoid receptor (MR) modulator. AZD9977 is used for heart failure, and chronic kidney disease research.

Dapagliflozin is a selective sodium-glucose co-transporter subtype 2 (SGLT2) inhibitor with antihyperglycemic activity. Dapagliflozin selectively and potently inhibits SGLT2 compared to SGLT1, which is the cotransporter of glucose in the gut. When combined with diet and exercise in adults, dapagliflozin helps to improve glycemic control by inhibiting glucose resorption in the proximal tubule of the nephron and causing glycosuria.

At recent SEC meeting for cardiovascular and renal, the expert panel reviewed Phase IIb clinical trial protocol of fixed dose combination drug AZD9977 and Dapagliflozin presented by Paraxel.

After detailed deliberation, the committee opined that only one disease either chronic kidney disease (CKD) or heart failure should be studied in proposed phase IIb study.

In accordance with the above, the expert panel directed the firm that the applicant should submit revised protocol.