Database for
Therapeutic Antibodies
Therapeutic Antibodies
| 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 |
| Target(s) | Factor D |
| Indications of clinical studies | Geographic atrophy associated with dry age-related macular degeneration |
| Primary therapeutic area | Ophthalmic disorders |
| 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 | 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 |
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
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |