dm+d

Unassigned

New Medicines

Candidemia and invasive candidiasis

Information

New molecular entity
Napp
Melinta

Development and Regulatory status

None
Pre-registration (Filed)
Pre-registration (Filed)
Yes
Sep 22FDA accepts NDA for priority review and assigns a PDUFA date of 22/03/23 [15].
Aug 22Filed in EU [14].
Jul 22Filed in US for treatment of candidemia and invasive candidiasis; a decision is expected Q1 23. Cidara have entered into a licence agreement with Melinta Therapeutics to commercialise rezafungin in the US [13].
Sep 21Cidara Therapeutics anticipates filing a New Drug Application (NDA) in the US and similar regulatory filings outside the US in mid-2022. [12]
Jan 21Granted orphan drug designation in EU [10].
Sep 19Cidara Therapeutics and Mundipharma agree to co-develop and market rezafungin outside USA and Japan for Infections.[9]
Sep 18US FDA granted Qualified Infectious Disease Product (QIDP) status and fast track designation for rezafungin acetate for the prevention of invasive fungal infections in adults undergoing allogeneic bone marrow transplantation [4].
Sep 18PIII ReSTORE trial (NCT03667690) evaluating efficacy and safety of once-weekly IV rezafungin compared to once-daily caspofungin in patients with candidemia and/or invasive candidiasis starts. The trial is currently enrolling in the USA, with plans to extend enrolment to Europe, Asia and Australia [4].
Mar 18PIII trials planned for mid 2018. [2]
Feb 16US FDA granted orphan drug designation and Qualified Infectious Disease Product (QIDP) status to IV rezafungin acetate for the treatment of candidaemia and invasive candidiasis.[3]
May 15US FDA granted a fast track designation to rezafungin acetate IV for the treatment of candidaemia and invasive candidiasis.[3]

Category

First in class echinocandin antifungal. Inhibits glucan synthase which enables dose dependent fungicidal activity.
The rate of candidaemia in England, Wales and N.Ireland was 3.3 per 100,000 population in 2018. The three most frequently identified Candida species from blood were C.albicans (40%), C. glabrata (29%) and C. parapsilosis (11%). [8]
Candidemia and invasive candidiasis
Intravenous

Trial or other data

Dec 21Company announce PIII RESTORE trial (n=187) met FDA & EMA-pre-specified primary endpoints vs. standard of care (caspofungin daily) based on all-cause mortality at Day 30 (23.7 v 21.3%) & global cure at Day 14 (59.1 v 60.6%), respectively, supporting regulatory filings mid-2022 [11].
Jul 19Positive data presented from PII double-blind, randomised STRIVE trial (NCT02734862) in 208 pts with candidaemia as once weekly i.v. rezafungin was generally well tolerated and effective. Overall Success was observed in 60^, 76% and 67% of pts on rezafungin 400mg then weekly 400mg or rezafungin 400mg then weekly 200mg or caspofungin 70mg daily respectively. [7]
Sep 18PIII randomised, double-blind ReSTORE trial (N=184, NCT03667690) initiated to evaluate the efficacy and safety of rezafungin (i.v.) 400mg loading dose then 200mg weekly vs. caspofungin OD in 184 pts in the USA with candidemia and/or invasive candidiasis for up to 4 weeks. The primary endpoint is all-cause mortality at day 30. The estimated primary completion date is Sept 2020.[6]
Mar 18Two PIII clinical trials are planned for mid-2018. These are the PIII ReSTORE Treatment Trial (A single, global, randomised, double-blind, controlled pivotal trial in ~150 pts with candidemia and/or invasive candidiasis which is expected to generate topline data in 2020). The design will be similar to the STRIVE trial, but with a primary outcome measure of all-Cause Mortality at day 30.[2]
Mar 18PII STRIVE trial met all of its primary objectives. Overall success was acheived by 57.6% of pts treated with 400mg of IV rezafungin given once weekly, 71% of pts treated with 400mg then 200mg of IV rezafungin given once weekly ad 64.3% of pts treated with caspofungin. Clinical Cure rates for these groups were 75.8%, 77.4% and 71.4% respectively.[2,4]
Nov 17Cidara Therapeutics completes enrolment in the STRIVE trial (n=114) in Candidiasis in Spain, Russia, Italy, Hungary, Greece, Canada, Bulgaria, Belgium (IV) (NCT02734862, EudraCT2015-005599-51). STRIVE was an international, multicentre double-blind trial evaluating the safety, tolerability and efficacy of once-weekly dosing of rezafungin acetate vs. once-daily dosing of caspofungin in pts with candidemia and/or invasive candidiasis. The trial enrolled 92 pts who were randomised to receive either 400 mg of rezafungin IV once weekly for 2-4 weeks (Group 1), or 400 mg for the first week followed by 200 mg once weekly for up to 4 weeks in total (Group 2). In the comparator arm (Group 3), patients received daily caspofungin IV according to the approved prescribing information, with an optional step down to oral fluconazole. This trial was designed to evaluate mycological eradication and resolution of systemic signs attributable to candidaemia at day 14, as the primary endpoint.[2,3]