Cidara Therapeutics : ReSTORE Phase 3 Trial Results for Rezafungin

ReSTORE PHASE 3 TRIAL RESULTS FOR REZAFUNGIN

1	L E A D I N G T H E S C I E N C E O F P R O T E C T I O N	D e c 2 0 2 1

F O R WA R D - LO O K I N G S TAT E M E N T S

T h e s e s l i d e s c o n t a i n f o r w a r d - l o o k i n g s t a t e m e n t s w i t h i n t h e m e a n i n g o f t h e P r i v a t e S e c u r i t i e s L i t i g a t i o n R e f o r m A c t o f 1 9 9 5 .

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R EZ A F U N G I N OV E R A L L P H A S E 3 D E V E LO P M E N T P L A N

P H A S E 3 T R E AT M E N T T R I A L

P H A S E 3 P R O P H Y L A X I S T R I A L

POTENTIAL INDICATION	Treatment of candidemia & invasive	Prophylaxis against Aspergillus, Candida &
candidiasis	Pneumocystis in allogeneic blood and
		marrow transplant patients
PHASE 3 SIZE	187 patients1 (20% NI margin)	462 patients (12.5% NI margin)
OVERALL OBJECTIVE	FDA: Day 30 All-Cause Mortality vs SOC	Day 90 Fungal free survival vs standard
		of care

3 1. mITT population.

R e S T O R E P H A S E 3 T R I A L D ES I G N

• A Phase 3, prospective, double-blind, randomized, international, multicenter trial
• Evaluate the efficacy and safety of once-weekly IV rezafungin vs once-daily caspofungin followed by optional oral fluconazole step-down in the treatment of documented candidemia and/or IC
• mITT population: All subjects in safety population who had documented Candida infection

Rezafungin

N= 93

400/200mg

Weekly

Caspofungin

N= 94

70/50mg

Daily

				Global	Global Cure					All-Cause Mortality		End of Follow Up Period
				Cure	(1° ENDPOINT - EMA)			(1° ENDPOINT - FDA)
		Dose			Optional dose
Week	1		2	3		4	5	6	7	8	9
Day
			5		14						30

		Dose			Optional dose
Week	1		2	3		4	5	6	7	8	9

4 Global Cure is defined as Clinical Cure (as assessed by the Primary Investigator), Mycological Eradication and Radiological Cure (for qualifying invasive candidiasis patients only).

R e S T O R E P H A S E 3 T R I A L R ES U LT S S U M M A RY

P r i m a r y Ef f i c a c y E n d p o i n t s

• Both the FDA All-Cause Mortality at Day 30 as well as the EMA Global Cure at Day 14 endpoints were achieved

S e c o n d a r y Ef f i c a c y E n d p o i n t s

• Early efficacy outcomes (Day 5 Global Cure, Day 5 Mycological Eradication) were either similar or trended higher in the rezafungin arm

E x p l o r a t o r y Ef f i c a c y E n d p o i n t s

• Blood cultures were cleared more quickly in the rezafungin arm though the difference was not significant
• Duration of ICU stay was lower in the rezafungin group compared to caspofungin

S a fe t y

• Rates of Adverse Events and Serious Adverse Events were similar between the two study arms

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