Zydus Announces Phase 3 Trial of Desidustat in Non-Dialysis Dependent Chronic Kidney Disease (CKD) P

Zydus Announces Phase 3 Trial of Desidustat in Non-Dialysis Dependent Chronic Kidney Disease (CKD) P

Zydus Cadila, an innovation-driven, global pharmaceutical company, announced the Phase III trials of Desidustat, an Investigational New Drug targeted at treating anemia in non-dialysis dependent chronic kidney disease (NDD-CKD) patients. This Phase III study will be a multicenter (50- 60 sites), randomized, active-controlled clinical trial to evaluate the efficacy and safety of Desidustat versus Darbepoetin for the treatment of anaemia in patients with chronic kidney disease (CKD) who are not on dialysis.

Speaking on the development, Mr. Pankaj R. Patel, Chairman, Zydus Group said, “This innovation has the potential to bring about a paradigm shift in the management of CKD patients with anemia. An HIF-PH inhibitor could provide an oral, safer alternative to currently available erythropoietinstimulating agents (ESAs), which are associated with increased risk of cardiovascular events and have to be given via injections and a cold chain has to be maintained. This is a significant milestone in our research journey.” Earlier, Desidustat had met its primary endpoints in the Phase II clinical study of Non-dialysis dependent Chronic Kidney Disease (NDD-CKD) patients suffering from anemia. The Phase II NDD-CKD study was a randomized, double-blind, placebo-controlled study of the efficacy and safety of Desidustat for the treatment of anemia in CKD patients not on dialysis. Desidustat demonstrated superiority in efficacy versus placebo in terms of hemoglobin (Hb) response rate at all doses tested when compared to placebo over six weeks. This result was supported by the efficacy demonstrated across multiple secondary endpoints. The Phase I trials were earlier completed in Australia. Detailed data from this NDD-CKD Phase II study will be published in the peer-reviewed scientific journal ‘American Journal of Nephrology’.

Anemia Chronic Kidney Disease is a serious medical condition involving gradual loss of functioning of kidneys eventually leading to kidney failure. More than 200 million people worldwide are estimated to be living with CKD. In a Chronic Kidney Disease condition, the kidneys fail to produce EPO and this leads to low levels of hemoglobin (Hb) in the blood or anemia.

Desidustat is a novel, oral, HIF-PH inhibitor being developed for treating anemia in Chronic Kidney Disease patients. In Phase I studies Desidustat was well tolerated at doses from 10 to 300 mg. About 27-42% of Desidustat was eliminated by renal route in healthy volunteers. In Phase II studies in non-dialysis dependent CKD patients, Desidustat was found to be safe and well tolerated at 100 mg, 150 mg and 200 mg alternate-day dosing regimen. No serious AEs were observed. In Phase II pre-dialysis CKD subjects there was an increase in Cmax and AUC as compared to healthy volunteers. However, no accumulation was observed on repeated dosing. Higher exposure observed in non-dialysis dependent CKD patients as compared to healthy individuals may have led to greater erythropoietic response even at the lower doses. Publications on Desidustat (ZYAN1): 1. Phase I Clinical Study of ZYAN1, A Novel Prolyl-Hydroxylase (PHD) Inhibitor to Evaluate the Safety, Tolerability, and Pharmacokinetics Following Oral Administration in Healthy Volunteers.

Zydus receives final approval from the USFDA for Acetazolamide for Injection

Zydus Cadila has received the final approval from the USFDA to market Acetazolamide for Injection USP (US RLD – Diamox for Injection), 500 mg per single-dose vial. It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad.

Acetazolamide is a potent carbonic anhydrase inhibitor, effective in the control of fluid secretion (e.g. some types of glaucoma), treatment of certain convulsive disorders (e.g. epilepsy) and promotion of diuresis in instances of abnormal fluid retention (e.g. cardiac edema). The group now has 262 approvals and has so far filed over 350 ANDAs since the commencement of the filing process in FY 2003-04.