Pipeline - Annexon Biosciences
	
	
	
	
	
	
	
	
	
	
	
	
	
	
	
	
	
















		
		

 



	
clinical pipeline
for diseases of the body, brain & eye

STOP COMPLEMENT-MEDIATED DISEASES AT THE START

Annexon is pioneering a class of new complement medicines for patients with classical complement-mediated disorders of the body, brain and eye. We are conducting ongoing clinical trials in multiple serious autoimmune, neurodegenerative and ophthalmic diseases.

Advancing Pipeline of ‘Fit for Purpose’ Drug Candidates Across Multiple Complement-Targeted Diseases

Targeting Both Rare & Large Patient Populations

Candidate Design Franchise/Indication Preclinical Phase 1 Phase 2 Phase 3 Anticipated Milestones
FLAGSHIP PROGRAMS
ANX005 IV mAb Person icon Guillain-Barré Syndrome (GBS)

RWE & BLA submission 1H25

ANX007 IVT Fab Eye icon Geographic Atrophy (GA)

Initiate Phase 3 ARROW trial in 2H 2024

ARCHER II data 2H 2026

ANX1502 Oral small molecule Person icon Autoimmune Indications

POC 2H 2024

NEXT WAVE PROGRAMS
ANX005 IV mAb Brain icon Huntington’s Disease (HD)
Poised for late-stage Phase 2b/3 development
Brain icon Amyotrophic Lateral Sclerosis (ALS)
Poised for late-stage Phase 2b/3 development
ANX009 Subcutaneous Fab Person icon Lupus Nephritis (LN)
Evaluating options for future development

PATIENT ACCESS

At Annexon Biosciences, we are committed to bringing medicines to patients with complement-mediated diseases of the body, brain and eye. At present time, our therapeutic candidates are investigational, meaning that they have not been approved as safe effective for their intended use(s) by regulatory health authorities, such as the United States Food and Drug Administration (FDA).

Expanded access, also called “compassionate use,” provides a pathway for patients to gain access to certain investigational drugs for serious or life-threatening diseases or conditions. Providing access to investigational therapies through an expanded access program is a complex matter. We are currently evaluating the safety of our investigational therapies across multiple clinical trials, and before we provide patients with access to these therapies, we want to ensure that doing so will not inadvertently cause harm to those patients or potentially compromise our broader clinical development program, which is shaped by our data and by insight from the FDA and other regulatory authorities.

We believe that diligent adherence to the formal clinical development and regulatory approval processes offers the greatest potential for us to have a positive impact on the patients for whom our investigational therapies are designed to benefit. With these goals in mind, our focus is on completing our clinical trials in an effort to generate the necessary evidence of safety and efficacy required to obtain regulatory approval.

For these reasons, Annexon is not currently offering access to its investigational therapies outside of a clinical trial setting. We encourage those interested in gaining access to our investigational therapies to consult their physician regarding the possibility of participating in one of our clinical trials. A listing of our clinical trials can be found on publicly accessible databases, such as clinicaltrials.gov.

Additional questions can be submitted to:

info@annexonbio.com

Thai-chi woman