Bertilimumab Granted Fast Track Designation for the Treatment of Bullous Pemphigoid
Company to provide corporate update during conference call with live audio webcast on Thursday, September 13th at 8:30am EDT
FORT LEE, N.J., Sept. 11, 2018 (GLOBE NEWSWIRE) -- Immune Pharmaceuticals, Inc. (OTCQB: IMNP) (“Immune” or the “Company”), a biopharmaceutical company developing novel therapeutic agents for the treatment of immunologic and inflammatory diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to bertilimumab for the treatment of bullous pemphigoid.
“I am truly grateful that the FDA has granted Fast Track designation to bertilimumab for the treatment of bullous pemphigoid. This important achievement follows the recent granting of Orphan Drug Designation in both the United States and Europe, which together demonstrate the regulatory affairs momentum our team has achieved,” commented Immune’s Interim Chief Executive Officer, Tony Fiorino, MD, PhD. “There is no doubt that bertilimumab development will benefit from the opportunity to have more frequent contact with the FDA, particularly now, as we move forward with a new manufacturing process and plan for a phase 2/3 pivotal study in bullous pemphigoid.”
The FDA’s Fast Track program is designed to facilitate the development and expedite the review of drugs to treat serious conditions that are unmet medical needs. Fast Track designation enables more frequent interactions with the FDA in order to shorten the development and review process, and may include potential eligibility for Accelerated Approval, Priority Review and Rolling Review.
CONFERENCE CALL AND WEBCAST DETAILS
Immune will host a live conference call and webcast to provide a corporate update on Thursday, September 13, 2018 at 8:30 a.m. EDT.
To participate in the call, please dial 877-407-9122 (domestic) or 201-493-6747 (international). The live webcast will be available on the Events page of the Investors section of the Company’s website (https://www.immunepharma.com/), and will be archived for 60 days.
About Immune Pharmaceuticals, Inc.
Immune Pharmaceuticals Inc. is a biopharmaceutical company developing novel therapeutic agents for the treatment of immunologic and inflammatory diseases. Immune's lead program, bertilimumab, is a first-in-class, human monoclonal antibody that targets eotaxin-1, a chemokine that plays a role in immune responses and attracts eosinophils to the site of inflammation. By blocking eotaxin-1, bertilimumab may prevent the migration and activation of eosinophils and other cells, thus blocking an important inflammatory pathway active in a variety of allergic and immune diseases. Bertilimumab has shown promising clinical activity in bullous pemphigoid and has been studied in other conditions including allergic rhinitis and ulcerative colitis, and may have application in other diseases, including atopic dermatitis, asthma, and other diseases. Immune is also developing NanoCyclo, a nano-encapsulated formulation of cyclosporin, which is in late stage preclinical development for atopic dermatitis and psoriasis
Safe Harbor Statements Regarding Forward Looking Statements
The statements in this news release made by representatives of Immune relating to matters that are not historical facts, including without limitation, those regarding future performance or financial results, the timing or potential outcomes of research collaborations or clinical trials, any market that might develop for any of Immune's product candidates and the sufficiency of Immune's cash and other capital resources, the continued development by Immune of bertilimumab are forward-looking statements that involve risks and uncertainties, including, but not limited to, the likelihood that actual performance or results could materially differ, that future research will prove successful, the likelihood that any product in the research pipeline will receive regulatory approval in the U.S. or abroad, or Immune's ability to fund such efforts with or without partners. Immune undertakes no obligation to update any of these statements. In addition, there can be no assurance that Immune will be able to reduce expenses, capitalize on strategic alternatives, develop its assets, and generate value for shareholders. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as to the date hereof. Accordingly, any forward-looking statements should be read in conjunction with the additional risks and uncertainties detailed in Immune's filings with the Securities and Exchange Commission, including those discussed in Immune's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and periodic reports filed on Form 8-K.
SOURCE Immune Pharmaceuticals Inc.
Released September 11, 2018