Immune Pharmaceuticals Provides a Pipeline Update
23 Mai 2018 - 2:00PM
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.”
Bertilimumab Update
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.
NanoCyclo Update
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.
Near-Term Milestones
- 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.
Investor Contact:
Jenene ThomasJenene Thomas Communications, LLC+1
(833) 475-8247 imnp@jtcir.com
SOURCE Immune Pharmaceuticals Inc.
(USOTC:IMNPQ)
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