Immune Pharmaceuticals Presents Updated Positive Results from Phase 2 Trial of Bertilimumab in Bullous Pemphigoid
15 Mai 2018 - 3:00PM
- Results from all subjects confirm
excellent safety and tolerability and a large benefit across a
variety of efficacy measures despite aggressive prednisone tapering
-
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 announced that updated data from its
phase 2 study of bertilimumab in patients with
moderate-to-extensive bullous pemphigoid (BP)
(study NCT02226146) are being presented today at the 2018
Pre-IID Pemphigus and Pemphigoid Symposium in Orlando, FL. These
updated results include complete follow-up on all subjects enrolled
in the study. Subjects in the study experienced a decline in
the Bullous Pemphigoid Disease Area Index (BPDAI) Activity Score of
81% (p=0.015) at day 84 from a mean baseline score of 67, with 86%
of subjects showing at least a 50% improvement in the BPDAI
Activity Score and 57% showing at least a 90% improvement. Over the
course of the study, subjects in the study also had improvements in
pruritus, a very challenging symptom for patients with BP, and
quality of life. These benefits were seen quickly, with a mean
reduction in BPDAI Activity Score of 70% by day 42. For a subgroup
of subjects within which lesion healing was assessed, all six
showed healing of prior lesions by day 28. These improvements were
observed despite subjects receiving only three doses of
bertilimumab (on days 0, 14 and 28) and modest doses of prednisone
that were aggressively tapered. The mean starting dose of
prednisone was 28 mg (0.33 mg/kg) which was reduced to 17 mg (0.19
mg/kg) by day 42 (p=0.022) and to 12 mg (0.15 mg/kg) by day 84
(p=0.005). 40% of subjects had a prednisone dose of 10 mg/day or
less by day 42, and 58% had achieved 10 mg/day or less by day 84.
The standard of care for BP patients treated with systemic steroids
is a starting dose of 0.5-1.0 mg/kg tapered slowly over the course
of 6-12 months, and subjects in this study received on average
approximately 2,900 mg less prednisone than called for by the
regimen of Joly et al (Joly et al, New Engl J Med
2002; 347:143-145) and 1,700 mg less prednisone than called for by
British treatment guidelines (Venning et al, Br J
Dermatol 2012: 1200-1214). These and additional results
will be presented in an oral presentation by Neil Korman, MD, PhD,
Director Clinical Trials Unit and the Murdough Family Center for
Psoriasis, University Hospitals Cleveland Medical Center, and
Professor of Dermatology, Case Western Reserve University School of
Medicine, and a member of the Company’s Scientific Advisory Board,
and in a poster to be presented by Immune’s Chief Medical and
Operating Officer, Tony Fiorino, MD, PhD. Following the conference,
the poster will be available on the Company’s website. Dr. Fiorino
stated, “I am gratified to have brought this important study to a
close. The subjects in this study showed rapid improvement despite
low doses of prednisone, which strongly suggests bertilimumab is
active in bullous pemphigoid. Our next study will include a much
longer treatment period, which could provide further benefits. We
intend to discuss our plans for a randomized, controlled phase 2/3
study of bertilimumab in bullous pemphigoid with the FDA later this
year, and we believe this next trial could serve as a
registrational study in this orphan disease with no FDA-approved
therapies. We expect to launch this pivotal study in 2019, using
bertilimumab produced by our new manufacturing process.”
About the International Pemphigus & Pemphigoid
Foundation (IPPF) The International Pemphigus &
Pemphigoid Foundation’s most important objectives are to provide
patients and doctors worldwide with information about pemphigus and
pemphigoid, and to provide patients and their caregivers much
needed comfort and support so they can continue to live active,
productive lives. To ensure that IPPF is able to provide the most
current information about the disease and treatments, IPPF has
developed and continue to maintain close relationships with doctors
and leaders in the medical community, including the National
Institutes of Arthritis, Musculoskeletal and Skin Diseases (NIAMS),
part of the National Institutes of Health, and the American Academy
of Dermatology (AAD). The IPPF is also an active member of a number
of other organizations that help us fulfill our role as patient
advocates and enable us to have more impact as we work together:
National Organization of Rare Disorders (NORD), the Coalition of
Skin Diseases (CSD), Derma Care Access Network (DCAN) and the
International Alliance of Patient Organizations (IAPO). For more
information, please visit the IPPF website.
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. 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.
Investor Contact:Jenene
ThomasJenene Thomas Communications, LLC+1 (833) 475-8247
imnp@jtcir.com
SOURCE Immune Pharmaceuticals Inc.
(USOTC:IMNPQ)
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