Englewood Cliffs, NJ (May 23, 2018) – Immune Pharmaceuticals, Inc. (NASDAQ: IMNP) (“Immune” or the “Company”), a biopharmaceutical company developing novel therapeutic agents for the treatment of immunologic and inflammatory diseases, today provided an update on its pipeline.
“We are pleased with the progress we have made so far this year, particularly in the clinical advancement of our lead program, bertilimumab,” commented Elliot Maza, President and CEO of Immune. “We completed enrollment in our phase 2a bullous pemphigoid trial in the last quarter and all study visits have been completed. We believe the positive data from this study are strongly supportive of our plans to commence a pivotal phase 2/3 study next year. Also, we continue to advance our phase 2 proof-of- concept ulcerative colitis study with the goal of completing enrollment next quarter. In our NanoCyclo program, skin permeation and animal studies are underway that will allow us to select a final formulation this quarter to move into toxicology studies. Finally, we continue discussions with parties potentially interested in acquiring certain of Cytovia’s assets. These achievements, reflecting our focus on execution across both our bertilimumab and NanoCyclo programs, are important contributors to what is a transformational year for Immune as we move towards a pivotal bertilimumab study in 2019.”
Recently, the Company announced updated positive results from the phase 2a bullous pemphigoid (BP) study. Subjects in the study had statistically significant improvements in disease activity despite starting the study on a low dose of prednisone, which was tapered aggressively over the 12-week follow-up. Subjects also experienced improvements in pruritus and quality of life, and the safety and tolerability of bertilimumab in this elderly population was excellent. Data from this study have been presented at two international dermatology congresses this year and have generated enthusiasm among physicians who treat BP. Pharmacokinetic and pharmacodynamic data from this study is expected to be available in the third quarter of this year.
Importantly, Immune has begun planning for a randomized, controlled phase 2/3 trial to launch in 2019, which the Company expects will serve as a registrational study. The Company is preparing for meetings with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) later this year to discuss the planned phase 2/3 study as well as important manufacturing plans.
Immune recently released a new batch of bertilimumab to support its ongoing phase 2a ulcerative colitis study, which will allow a ramp-up of enrollment. The Company continues to expect enrollment to complete in the third quarter of this year.
The Company continues to invest significant resources in its new bertilimumab manufacturing process and expects to select a contract manufacturer for future clinical supplies and to initiate the technology transfer in this quarter. The Company is preparing important patent applications based on the new process.
A series of laboratory and animal studies to allow selection of a final formulation launched this quarter, as planned. Immune is currently planning a toxicity study to begin in the third quarter, which will allow the launch of the clinical development program.
The Company is working closely with its partner and NanoCyclo manufacturer, BioNanoSim, to validate BioNanoSim’s facility for clinical manufacturing. Immune expects to commence its planned proof-of- concept clinical trial late in the fourth quarter of 2018 or early in the first quarter of 2019.
- Select CMO for new bertilimumab manufacturing process and initiate tech transfer in Q2 2018;
- Select NanoCyclo formulation for clinical development in Q2 2018;
- Complete enrollment of bertilimumab phase 2 UC study in Q3 2018;
- Release pharmacokinetic and pharmacodynamic data from BP-01 study in Q3 2018;
- Run clinic-enabling NanoCyclo toxicity study in Q3 2018;
- Meet with FDA and EMA for bertilimumab BP program in Q3/Q4 2018;
- Initiate NanoCyclo CGMP manufacturing in Q3/Q4 2018;
- Complete engineering run for new bertilimumab manufacturing process in Q4 2018;
- Initiate long-term bertilimumab toxicity study in Q4 2018; and
- Commence NanoCyclo psoriasis proof-of-concept clinical trial in Q4 2018/Q1 2019.
Mr. Maza concluded, “With bertilimumab shining in the bullous pemphigoid clinical program and poised to enter a registrational study next year, we believe more than ever that the value of this program remains under-appreciated. Now that the corporate restructuring is behind us, we hope that investors will increasingly recognize the exciting potential of this program. We remain confident that by continuing to focus on advancing bertilimumab and NanoCyclo, we will build investor interest and confidence in these programs.”
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 binds eotaxin-1, a chemokine that 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 or its determination to seek Orphan Drug designation for the pharmaceutical product 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 United States or abroad, or Immune’s ability to fund such efforts with or without partners. Immune undertakes no obligation to update any of these statements. 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.
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SOURCE Immune Pharmaceuticals Inc.