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A New Class of Broad-Spectrum Antibacterial Agents to Treat Multi-Drug Resistant Pathogens

Award Number: R44AI170297
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/21/2023
PERIOD OF PERFORMANCE END DATE: 06/30/2026

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A New Class of Broad-Spectrum Antibacterial Agents to Treat Multi-Drug Resistant Pathogens - Project Summary Cūrza is developing the CZ-02 platform of broad-spectrum antibiotics as a new class focusing on multidrug- resistant (MDR) Gram-negative pathogens that will also be efficacious against Gram-positive bacteria. CZ-02 antibacterials bind to a unique site on the bacterial ribosome that is not targeted by antibiotics available clinically which is expected to limit cross-resistance to other antibiotics. The initiation and subsequent development of the CZ-02 program represents a strong example for revisiting the use of natural products in drug discovery which has fallen out of favor in Pharma. CZ-02s were inspired by the natural product amicetin which selectively inhibits bacterial protein synthesis but suffers from limited antibacterial activity and poor drug-like properties. Careful engineering of the natural product has produced CZ-02s with exquisite selectivity for bacterial protein synthesis, potent antibacterial activity and excellent drug-like properties that have demonstrated efficacy against MDR pathogens in multiple animal models of infection while sparing mammalian cells from cytotoxicity. The goal of this Direct-to-Phase II project is to develop a new antibacterial drug candidate that covers Gram- negative pathogens found among Enterobacterales and the non-fermenters Acinetobacter baumanni and Pseudomonas aeruginosa as well as Gram-positive pathogens. The initial clinical indication will be for treating Urinary Tract Infections (UTIs), with other indications to follow (e.g. complicated intra-abdominal infections, pneumonia, bacteremia). At the conclusion of this Phase II SBIR will be a pre-clinical development candidate that is potent with broad spectrum activity that will be ready for Chemistry, Manufacturing and Controls (CMC) and toxicology/safety pharmacology under Good Laboratory Practices (GLP). Advancement of this antibacterial lead series will be accomplished by the following aims. Aim 1 will expand the spectrum of activity for advanced leads that have shown efficacy in UTI animal models with MDR Gram-negative pathogens. Curza’s proprietary model for producing potent and selective inhibitors of bacterial P-site protein synthesis, in combination with a battery of biological/biochemical activity assays (biochemical, microbiological, in vitro ADME-Tox), will be used for chemistry efforts to ensure compounds retain activity while expanding the spectrum of addressable pathogens to include A. baumannii and P. aeruginosa. Aim 2 will define pharmacokinetics (PK) while identifying the maximum tolerated dose and confirming efficacy by testing in thigh infection models to select CZ-02s for evaluation in UTI models. A lead and backup drug candidate will be selected in Aim 3 by evaluation in UTI models of antibiotic-resistant bacteria followed by non-GLP toxicology in rats to nominate a lead and backup. Aim 4 will scale-up production (non-GLP) to support in vivo studies while Aim 5 will establish the optimal dosing strategy from PK/Pharmacodynamic (PD) studies.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $858,436 )
2025	2025	CURZA INC	650 S KOMAS DR STE 202	SALT LAKE CITY	UT	84108	SALT LAKE	USA	Allergy and Infectious Diseases Research	000	3	6/11/2025	NON-COMPETING CONTINUATION	$858,436
														Subtotal = $858,436

Issue Date FY: 2024 ( Subtotal = $1,000,000 )
2024	2024	CURZA INC	650 S KOMAS DR STE 202	SALT LAKE CITY	UT	84108	SALT LAKE	USA	Allergy and Infectious Diseases Research	000	2	6/11/2024	NON-COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,000,000

Issue Date FY: 2023 ( Subtotal = $1,000,000 )
2023	2023	CURZA INC	650 S KOMAS DR STE 202	SALT LAKE CITY	UT	84108	SALT LAKE	USA	Allergy and Infectious Diseases Research	001	1	8/15/2023	NEW	$0
2023	2023	CURZA INC	650 S KOMAS DR STE 202	SALT LAKE CITY	UT	84108	SALT LAKE	USA	Allergy and Infectious Diseases Research	000	1	7/21/2023	NEW	$1,000,000
														Subtotal = $1,000,000

Grand Total All Awards = $2,858,436

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A New Class of Broad-Spectrum Antibacterial Agents to Treat Multi-Drug Resistant Pathogens

Award Number: R44AI170297

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/21/2023

PERIOD OF PERFORMANCE END DATE: 06/30/2026

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