Lampalizumab Terminated Naked monospecific

Antibody Information

Entry ID	2438
INN	Lampalizumab
Status	Terminated
Drug code(s)	RG7417, FCFD4514S
Brand name	None
mAb sequence source	mAb humanized
General Molecular Category	Naked monospecific
Format, general category	Fragment
Format details	Fab
Isotype (Fc)	None
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	Factor D
Indications of clinical studies	Geographic atrophy associated with dry age-related macular degeneration
Primary therapeutic area	Ophthalmic 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)	Terminated at Phase 3
Status	Inactive
Start of clinical phase (IND filing or first Phase 1)	May 15, 2009
Start of Phase 2	December 15, 2010
Start of Phase 3	September 15, 2014
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	Genentech
Licensee/Partner	None
Comments about company or candidate	Article entitled "Efficacy and Safety of Lampalizumab for Geographic Atrophy Due to Age-Related Macular Degeneration Chroma and Spectri Phase 3 Randomized Clinical Trials" published in JAMA Opthalmology on June 2, 2018; lampalizumab did not reduce GA enlargement vs sham during 48 weeks of treatment in these studies. Aug 2018: All studies completed. Oct 2017: Roche announced that based on a negative readout for lampalizumab for geographic atrophy in the SPECTRI trial, that program will not be moving ahead. Aug 2017: Phase 2 NCT01602120 study recruiting, 3 Phase 3 studies either recruiting or active not recruiting. Phase 2 MAHALO study met its primary efficacy endpoint (press release August 2013)
Full address of company	South San Francisco, California, United States North America United States of America https://www.gene.com/contact-us/visit-us

Description/comment

Designed to inhibit complement activation and chronic inflammation in tissues. Complement Factor D is a member of the trypsin family of peptidases and is a component of the alternative complement pathway

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None