Immune Pharmaceuticals Provides a Corporate Update
Conference call with live audio webcast today, Thursday, September 13th at 8:30am EDT
FORT LEE, N.J., Sept. 13, 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, today provided a corporate update.
“There have been many positive developments at Immune during this time of transition,” stated interim Chief Executive Officer Tony Fiorino, MD, PhD. “The recent regulatory successes for bertilimumab underscore the progress that can be made with focus and execution. I am proud of the dedication of our team and honored to work with them to move bertilimumab forward. I believe over the coming months, as will build further value into bertilimumab and will have the pieces in place to pursue a partnership that will support the planned phase 2/3 pivotal study.”
Highlights of Dr. Fiorino’s update include:
- An update on Immune’s manufacturing partnership with WuXi Biologics. The tech transfer is well underway and the current timeline calls for the first 2,000 liter production run in the second half of 2019 and release of clinic-ready bertilimumab in a range of late 2019 through the second quarter of 2020.
- Expectations of additional pharmacokinetic and pharmacodynamic data from the bullous pemphigoid phase 2a trial (fourth quarter 2018), and important meetings with the FDA (fourth quarter of 2018) and EMA (first quarter 2019), with planning for a pivotal phase 2/3 study already underway.
- Conclusion of enrollment in the phase 2 ulcerative colitis study over the coming weeks, with preliminary results expected late in the first quarter of 2019.
- Determination that asthma will be the next clinical indication for bertilimumab and release of preclinical asthma data in the fourth quarter of 2018.
- Decision to actively seek a partnership for bertilimumab after several near-term milestones are achieved that will enhance bertilimumab’s value.
- Results of a target engagement study for NanoCyclo anticipated for the fourth quarter of 2018, with subsequent steps for the NanoCyclo program dependent on the Company’s financial status.
- An update on strategic discussions regarding Ceplene and the disposition of various other non-core programs.
- A summary of the financial outlook.
The conference call and webcast details are below:
Immune will host a live conference call and webcast to provide a corporate update today, 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 13, 2018