Exhibit 99.1

 

 

Annexon Biosciences Reports Fourth Quarter and Full-Year 2020 Financial Results

with Recent Business Highlights

 

SOUTH SAN FRANCISCO, Calif., March 25, 2021

– Today Annexon, Inc.  (“Annexon”) (Nasdaq: ANNX), a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, brain and eye, announced fourth quarter and full-year 2020 financial results and business highlights.

 

Recent Business Highlights

 

Annexon continues to make strong progress in advancing its broad and deep pipeline and clinical programs across a  range of potential indications.  Recent highlights include:

 

 

ANX005 in Guillain-Barré Syndrome (GBS).  In March 2021, the company completed evaluation of its drug-drug interaction (DDI) study of ANX005 co-administered with Intravenous Immunoglobulin (IVIg) in 14 patients with GBS.  The DDI study was conducted to evaluate the safety and tolerability of ANX005 and IVIg co-administration in GBS patients, and measured pharmacokinetics (PK) and pharmacodynamics (PD) of ANX005 when administered in combination with IVIg.  IVIg, though not FDA-approved in the United States for GBS, is currently the standard of care for GBS.  Initial results from the DDI study included:

 

 

o

Co-administration of IVIg-ANX005 was well-tolerated.

 

o

Co-administration of IVIg-ANX005 achieved full C1q target engagement, and C1q suppression was maintained within the targeted range.

 

o

The open-label DDI study was not placebo-controlled or powered for statistical significance on efficacy measures.  A number of key GBS outcome measures were recorded from baseline, and early improvement was observed in GBS patients, including increased muscle strength, decreased neurofilament light chain (NfL) and improved GBS disability score.

 

Full results from the DDI study are expected to be submitted to a peer-reviewed forum in 2021.  A placebo-controlled Phase 2/3 trial is ongoing to evaluate the efficacy of ANX005 monotherapy in improving disability in GBS patients.  Data from the Phase 2/3 trial is anticipated in 2023.

 

 

ANX007 in Geographic Atrophy (GA). In February 2021, the company initiated a Phase 2 trial evaluating the efficacy of ANX007 in reducing the area of GA as evaluated by fundus autofluorescence (FAF) in patients with GA, which includes monthly and every other month dosing of ANX007.  Data from this trial is anticipated in 2023.

 

 

In February 2021, Annexon appointed William H. Carson, M.D. to the Board of Directors.  Concurrent with Dr. Carson’s appointment, Thomas G. Wiggans was appointed as Annexon’s chairman.

 

“We continue to make progress against our vision of building a leading, multi-faceted complement therapeutics company with an innovative portfolio for a broad range of autoimmune, neurodegenerative and ophthalmic diseases,” said Douglas Love, Esq., president and chief executive officer of Annexon.  “The DDI data gives us further confidence in ANX005.  We are rapidly advancing multiple Phase 2 clinical programs across a diverse set of potential indications, and accelerating development of a number of innovative, next generation product candidates.  This clinical momentum coupled with our strong capital position positions us well to drive value in 2021 and beyond.”

 

 


The following information was filed by Annexon, Inc. (ANNX) on Thursday, March 25, 2021 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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