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Development of novel endolysins targeting Cutibacterium acnes to treat acne vulgaris

Award Number: R44AR082722
ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/15/2023
PERIOD OF PERFORMANCE END DATE: 07/31/2027

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Development of novel endolysins targeting Cutibacterium acnes to treat acne vulgaris - PROJECT SUMMARY Acne vulgaris (acne) affects up to 50 million people in the U.S. annually and can have significant negative consequences on psychosocial functioning including higher rates of anxiety, low self-esteem, and depression. Cutibacterium acnes plays a central role in acne pathogenesis. Topical and oral antibiotics to target C. acnes remain part of first-line treatments for acne, but extensive use of antibiotics poses significant issues including exacerbation of antibiotic resistance as well as collateral damage to the healthy commensals in the gut and skin microbiomes. Given these drawbacks, novel antimicrobial agents that can provide alternatives to antibiotics and selectively target C. acnes without damaging beneficial bacteria are needed. Endolysins are phage-encoded enzymes that can degrade bacterial cell walls. Exogenously added endolysins can quickly lyse their target bacteria and because they bind very specific epitopes in target cell walls, they can have lytic specificity down to a single bacterial species. Given these properties, endolysins hold enormous potential as high-specificity skin microbiome modulators. However, the diversity of endolysins known to target C. acnes is very low and these enzymes suffer from low specificity, weak activity and poor solubility. As such, previous efforts to discover C. acnes endolysins with commercially-relevant properties have failed. In Phase I of this program, we leveraged our proprietary metagenomics platform and a synthetic biology-based approach to discover novel, soluble endolysins that target C. acnes and further improve them for high activity and specificity, overcoming this long-standing discovery bottleneck. In total, we developed 13 engineered enzymes that meet our target activity profile, including CUT-001 and CUT-002. We further developed base hydrogel formulations of CUT-001 and CUT-002 that have strong activity, good long-term stability, and was non-toxic / non-irritating in in vitro and in vivo safety tests. In Phase II of this program, we propose to develop a final CUT-002 hydrogel formulation, prototype a hydrocolloid patch incorporating CUT- 002, and develop an optimized CUT-002 bioreactor fermentation process. Successful completion of Phase II activities will result in a) two alternative product formulations/formats that meet our target product profile and can be advanced to clinical testing and b) cost-effective production of our lead enzyme at scale to support clinical testing and commercialization.


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: 2026 ( Subtotal = $576,499 )
2026	2026	TOPAZ BIOSCIENCES, INC.	1250 45TH ST STE 320	EMERYVILLE	CA	94608	ALAMEDA	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	3	7/17/2026	NON-COMPETING CONTINUATION	$576,499
														Subtotal = $576,499

Issue Date FY: 2025 ( Subtotal = $1,469,201 )
2025	2025	TOPAZ BIOSCIENCES, INC.	1250 45TH ST STE 320	EMERYVILLE	CA	94608	ALAMEDA	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	2	9/10/2025	COMPETING CONTINUATION	$446,351
2025	2025	TOPAZ BIOSCIENCES, INC.	1250 45TH ST STE 320	EMERYVILLE	CA	94608	ALAMEDA	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	2	7/29/2025	COMPETING CONTINUATION	$1,022,850
														Subtotal = $1,469,201

Grand Total All Awards = $2,045,700

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Development of novel endolysins targeting Cutibacterium acnes to treat acne vulgaris

Award Number: R44AR082722

ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/15/2023

PERIOD OF PERFORMANCE END DATE: 07/31/2027

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