Navigation Links
Anthera Announces the Advancement of Blisibimod into Phase 3 Development for Patients with Systemic Lupus Erythematosus (SLE)
Date:9/17/2012

HAYWARD, Calif., Sept. 17, 2012 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, today provided an update on regulatory discussions for the global development of blisibimod.  End of Phase 2 discussions with the US Food and Drug Administration (FDA) have been completed and will allow for the submission of Phase 3 protocols and the initiation of registration studies.  Earlier in 2012, Anthera received a written response from the European Medicines Agency (EMA) providing similar development feedback for the blisibimod program.

"We appreciate the FDA's rapid response to our development proposal for blisibimod. We will incorporate their comments and begin the initiation of our Phase 3 lupus program," said Paul F. Truex, Anthera's President and CEO.  "The PEARL-SC clinical study provided meaningful insight into the importance of selecting an appropriate patient population while also defining a meaningful endpoint.  We are grateful the FDA found this approach to be acceptable for further study and look forward to bringing blisibimod one step closer to patients in need."

The Phase 3 studies (CHABLIS-SC1 and CHABLIS-SC2) will be multicenter, placebo-controlled, randomized, double-blind studies designed to evaluate the efficacy, safety, tolerability and immunogenicity of blisibimod in patients with clinically active SLE (SELENA-SLEDAI > 10) who have not achieved optimal resolution of their disease with corticosteroid use.  Patients will be treated in the controlled part of each study for 52 weeks after which they will have the option to receive additional treatment as part of an open-label, long-term, follow-up safety study. The primary endpoint of the CHABLIS studies will be a Systemic Lupus Erythematosus Response Index (SRI*) including the requirement of an eight-point or greater improvement from baseline in the SELENA/SLEDAI disease measurement (SRI-8).

"The use of an SRI-8 endpoint, in a population with higher baseline disease activity requires patients to demonstrate improvement in the clinical presentations of SLE, such as skin, mucosal, joint disease and kidney disease," said Colin Hislop, Anthera's Chief Medical Officer.  "For example, the blisibimod 200 mg weekly dose reduced proteinuria by nearly 1 gram per 24 hours at Week 24 compared with minimal change in the placebo group.  This corresponds to an approximate 50% decrease from baseline. These types of improvements were responsible for the majority of clinical benefits seen in the PEARL-SC study and highlights blisibimod's potential to help patients with more active disease."

As previously reported, results from the PEARL-SC study indicate that in the predefined population of patients with clinically active disease (SELENA-SLEDAI > 10) who were also taking corticosteroids, the SRI-8 treatment benefit in the 200 mg weekly blisibimod cohort was statistically significant at week eight (22.6% blisibimod response versus 6.4% placebo response, p=0.023) and at week 16 (35.4% blisibimod response versus 17.0% placebo response, p=0.04) through the 24 week endpoint (41.7% blisibimod response versus 10.4% placebo response, p<0.001). Results from the PEARL-SC clinical study have been submitted to the American College of Rheumatology for presentation at the ACR/ARHP Annual Scientific Meeting 2012 in Washington, D.C.

*SRI is defined as patients who respond to treatment and achieve a reduction in SELENA-SLEDAI equal to or greater than the number indicated, no new BILAG A or two B organ domain scores, and no increase in Physician's Global Assessment (PGA) of greater than 0.3 on a three point scale.

About Anthera Pharmaceuticals

Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious diseases associated with inflammation and autoimmune diseases.

Safe Harbor Statement

Any statements contained in this press release that refer to future events or other non-historical matters, including statements that are preceded by, followed by, or that include such words as "estimate," "intend," "anticipate," "believe," "plan," "goal," "expect," "project," or similar statements, are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on Anthera's expectations as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially as set forth in Anthera's public filings with the SEC, including Anthera's Annual Report on Form 10-K for the year ended December 31, 2011 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2012.  Anthera disclaims any intent or obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.

CONTACT: Bianca Nery of Anthera Pharmaceuticals, Inc., bnery@anthera.com or 510.856.5586.


'/>"/>
SOURCE Anthera Pharmaceuticals, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Anthera Pharmaceuticals Reports 2012 Second Quarter Financial Results And Provides Clinical Progress Update
2. Anthera Pharmaceuticals Announces Exercise in Full of Over-Allotment Option and Completion of Public Offering of Common Stock
3. Anthera Pharmaceuticals Announces Pricing of Public Offering of Common Stock
4. Anthera Pharmaceuticals Announces Proposed Public Offering of Common Stock
5. Anthera Pharmaceuticals Provides Additional Data from the Recently Completed PEARL-SC Study of Blisibimod in the Proposed Phase 3 Population
6. Anthera Pharmaceuticals to Present at the 7th Annual JMP Securities Healthcare Conference
7. Anthera Updates Phase 3 Plans Following Results from the Phase 2b PEARL-SC Dose Ranging Study of Blisibimod
8. Anthera Pharmaceuticals Reports 2012 First Quarter Financial Results And Provides Clinical Progress Update
9. Anthera Announces First Quarter 2012 Financial Report and Conference Call
10. Anthera Announces the Completion of Patient Dosing in Phase 2b PEARL-SC Study
11. Merz, Inc. Announces Cynthia Schwalm as Vice President, Neurology
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... , June 26, 2016 One of Australia,s ... announced the formation of a new biotechnology company, Noxopharm Limited [ABN ... in an IPO and to list on the ASX. ... NOX66, ready to enter a Phase 1 clinical study later this ... to address one of the biggest problems facing cancer patients - ...
(Date:6/26/2016)... June 27, 2016 Jazz Pharmaceuticals plc (Nasdaq: ... under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as ... Celator Pharmaceuticals, Inc. ("Celator"; Nasdaq: CPXX ) ... Daylight Time). As previously announced on May ... definitive merger agreement under which Jazz Pharmaceuticals has commenced ...
(Date:6/26/2016)... , June 27, 2016  VMS Rehab Systems, Inc. ... will take whatever measures required to build a strong ... which is currently listed on the OTC Markets-pink current ... Chairman and CEO, "We are seeing an anomaly in ... understand, not only by the Company, but shareholders and ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... Experts from the American ... Annual Research Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. ... including advance care planning, healthcare costs and patient and family engagement. , AIR ...
(Date:6/25/2016)... ... , ... First Choice Emergency Room , the largest network of independent ... Director of its new Mesquite-Samuell Farm facility. , “We are pleased to announce ... Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, whether ... latter, setting the bar too high can result in disappointment, perhaps even self-loathing. However, ... their goal. , Research from PsychTests.com reveals that behind the tendency ...
(Date:6/24/2016)... PASADENA, CA (PRWEB) , ... June 24, 2016 , ... Marcy was in a crisis. ... he would lash out at his family verbally and physically. , “When something upset him, ... table, he would use it. He would throw rocks at my other children and say ...
(Date:6/24/2016)... San Diego, CA (PRWEB) , ... June 24, 2016 , ... ... up with the American Cancer Society and the Road To Recovery® program to drive ... care to seniors and other adults to ensure the highest quality of life and ...
Breaking Medicine News(10 mins):