Navenibart Clinical Naked monospecific

Antibody Information

Entry ID	1319
INN	Navenibart
Status	Clinical
Drug code(s)	STAR-0215
Brand name	None
mAb sequence source	mAb humanized
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG1
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	Plasma kallikrein
Indications of clinical studies	Hereditary angioedema
Primary therapeutic area	Cardiovascular / hemostasis disorders

Development stage information

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

Most advanced stage of development (global)	Phase 3
Status	Active
Start of clinical phase (IND filing or first Phase 1)	June 15, 2022
Start of Phase 2	September 15, 2023
Start of Phase 3	February 15, 2025
Date BLA/NDA submitted to FDA
Year of first approval (global)	None
Date of first US approval
INN, US product name	None
US or EU approved indications	None

Company information

Company	Astria Therapeutics Inc.
Licensee/Partner	None
Comments about company or candidate	Feb. 27, 2025-- Astria Therapeutics, Inc. announced the initiation of the ALPHA-ORBIT Phase 3 clinical trial of navenibart in people living with hereditary angioedema NCT06842823 Phase 3 in Hereditary Angioedema due to start in Mar 2025. Plan for Phase 3 in Q1 2025 (https://ir.astriatx.com/static-files/1c19b85e-1540-4180-9540-d625900759a4; https://ir.astriatx.com/static-files/50ee09de-62b3-4b14-9da6-c7c2238ce53e) Sep 30, 2024: Astria Therapeutics, Inc., a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, announced that navenibart (STAR-0215) has been granted Orphan Drug Designation for the treatment of hereditary angioedema by the U.S. Food and Drug Administration. NCT06007677 Phase 2 study started in Sep 2023. Jul. 20, 2023-- Astria Therapeutics, Inc. announced that the STAR-0215 development program has received Fast Track designation from the FDA for the treatment of Hereditary Angioedema NCT05695248 Phase 1/2 in Hereditary Angioedema started in Feb 2023. NCT05477160 Phase 1 started in July 2022. Jul. 28, 2022-- Astria Therapeutics, Inc., a biopharmaceutical company developing STAR-0215 for hereditary angioedema and focused on life-changing therapies for rare and niche allergic and immunological diseases, announced the U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application for STAR-0215, which the company is developing for the treatment of Hereditary Angioedema (HAE). A Phase 1a trial of STAR-0215 in healthy volunteers is expected to initiate in the coming weeks, with preliminary results anticipated by year-end.
Full address of company	75 State Street, Suite 1400, Boston, MA 02109 North America United States of America https://astriatx.com/contact-us/

Description/comment

STAR-0215 is a monoclonal antibody inhibitor of plasma kallikrein, designed to provide long-acting, effective HAE attack prevention.

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None