RAPT Therapeutics Announces Late-Breaking Oral Presentation of Positive Results from Phase 1b Trial of RPT193 at the 30th European Academy of Dermatology and Venereology Congress
September 30 2021 - 09:15AM
RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage,
immunology-based biopharmaceutical company focused on discovering,
developing and commercializing oral small molecule therapies for
patients with significant unmet needs in oncology and inflammatory
diseases, today announced that positive topline results from its
randomized placebo-controlled Phase 1b clinical trial of RPT193 as
monotherapy in 31 patients with moderate-to-severe atopic
dermatitis (AD) were presented at the European Academy of
Dermatology and Venereology (EADV) Congress by Robert Bissonnette,
M.D., FRCPC. Dr. Bissonnette is a board-certified dermatologist and
currently serves as president of the board of directors of the
International Eczema Council. He is also chief executive officer
and medical director of Innovaderm Research Inc., a contract
research organization that specializes in conducting clinical
studies in dermatology.
“These Phase 1 results strongly support the potential of RPT193
as an effective once-daily, oral treatment for atopic dermatitis
with a clean safety profile,” said Brian Wong, M.D., Ph.D.,
President and CEO of RAPT Therapeutics. “RPT193 demonstrated
impressive improvements in measures of disease severity, including
vIGA and EASI-75, which are the approvable endpoints in the US and
Europe. The magnitude and extended clinical benefits observed even
after dosing cessation are especially intriguing and warrant
further investigation. We look forward to initiating our Phase 2b
clinical trial in atopic dermatitis and to expanding our
exploration of RPT193 in a Phase 2a trial in asthma.”The Phase 1b
trial results demonstrated that at Day 29 after end of treatment,
clear benefit over placebo was observed on Eczema Area and Severity
Index (EASI) score, EASI-50, vIGA 0/1 (clear or almost clear skin),
body surface area (BSA), and pruritis NRS-3 and 4 (3 and 4 point
reduction on the numerical rating scale for itch). By the end of
study, including the two-week follow-up period (Day 43), RPT193
demonstrated continued improvement in the EASI, EASI-50, EASI-75,
EASI-90, vIGA 0/1, and BSA. In a post-hoc statistical analysis
comparing RPT193-treated patients to placebo-treated patients,
statistically significant improvements in EASI, EASI-50 and BSA
were observed at Day 43. RPT193 was well tolerated in the Phase 1b
study. No serious adverse events were reported, and all adverse
events reported were mild or moderate in intensity.
“These early-stage clinical results for RPT193 are very
promising and demonstrate its potential as an attractive,
differentiated treatment for atopic dermatitis,” said Dr.
Bissonnette. “Further improvement after cessation of dosing could
be consistent with unique kinetics associated with the mechanism of
action of RPT193 and its unique design in targeting Th2 cell
migration and function.”
About the Phase 1a/1b Study of RPT193The Phase
1b study reported today was part of RAPT’s first-in-human Phase
1a/1b trial of RPT193. The Phase 1b portion of the trial was a
randomized, double-blind, placebo-controlled study examining RPT193
as monotherapy in patients with moderate-to-severe AD. The study
was conducted at multiple sites in the United States and enrolled
31 patients with moderate-to-severe AD who had an inadequate
response to, or were intolerant of, topical corticosteroids. The
primary endpoint of the Phase 1b study was safety. Secondary and
exploratory endpoints included pharmacokinetics, biomarkers and
clinical efficacy as evaluated by multiple measurements, including
percent change in the Eczema Area and Severity Index (EASI) score,
change in body surface area (BSA) affected by AD, the validated
Investigator Global Assessment (vIGA) and pruritus Numerical Rating
Scale (NRS). The Phase 1b trial was not powered to achieve
statistical significance for any particular endpoint.
The Phase 1a portion of the Phase 1a/1b trial was a standard
single and multiple dose-escalation study in healthy volunteers.
The data from the Phase 1a study demonstrated pharmacokinetics and
pharmacodynamics that support once-daily oral dosing with RPT193,
and blinded safety data supported initiation of the Phase 1b
portion of the trial.
About RPT193 RPT193 is a small molecule oral
therapy in development for the treatment of atopic dermatitis and
other inflammatory diseases. RPT193 is designed to selectively
inhibit the migration of Th2 cells into inflamed tissues by
blocking CCR4, a receptor highly expressed on Th2 cells.
Preclinical data suggest that RPT193 also has the potential to
modulate Th2 cell function by lowering the secretion of Th2
cytokines upon stimulation. In allergic inflammatory diseases such
as AD, chemokines recruit Th2 cells via CCR4 into inflamed tissues,
where the Th2 cells secrete proteins known to drive the
inflammatory response. The role of Th2 cells has been clinically
validated by injectable biologics targeting this pathway. Patients
with atopic dermatitis express higher levels of CCR4 ligands
compared with healthy humans; these ligands also correlate with the
severity of disease. RAPT believes that by inhibiting CCR4, RPT193
has the potential to bring therapeutic benefit to patients across a
broad spectrum of inflammatory diseases, including atopic
dermatitis, asthma, chronic urticaria, allergic rhinitis, chronic
rhinosinusitis and eosinophilic esophagitis.
About Atopic Dermatitis Atopic dermatitis is a
highly prevalent chronic, inflammatory skin disease characterized
by skin barrier disruption and immune dysregulation. Patients with
AD have chronically inflamed skin lesions that can cause
debilitating pruritus (itch), which can severely impair quality of
life. While there is a marketed injectable product for the
treatment of AD, RAPT believes RPT193, if approved, could fill an
unmet medical need for the treatment of inflammatory disorders with
the convenience of once-daily oral dosing. There are ~19M adults
and ~10M children affected by AD in the US.
About RAPT Therapeutics, Inc.RAPT Therapeutics
is a clinical stage immunology-based biopharmaceutical company
focused on discovering, developing and commercializing oral small
molecule therapies for patients with significant unmet needs in
oncology and inflammatory diseases. Utilizing its proprietary
discovery and development engine, RAPT is developing highly
selective small molecules designed to modulate the critical immune
drivers underlying these diseases. RAPT has discovered and advanced
two unique drug candidates, FLX475 and RPT193, each targeting C-C
motif chemokine receptor 4 (CCR4), for the treatment of cancer and
inflammation, respectively. RAPT is also pursuing a range of
targets that are in the discovery stage of development.
Forward-Looking StatementsThis press release
contains forward-looking statements. These statements relate to
future events and involve known and unknown risks, uncertainties
and other factors that may cause our actual results, performance or
achievements to be materially different from any future
performances or achievements expressed or implied by the
forward-looking statements. Each of these statements is based only
on current information, assumptions and expectations that are
inherently subject to change and involve a number of risks and
uncertainties. Forward-looking statements include, but are not
limited to, statements about interpretations of the topline results
from the Phase 1b clinical trial of RPT193, clinical development
progress including the anticipated advancement of RPT193 to a Phase
2b trial in atopic dermatitis as well as Phase 2 trials in other
indications and the potential of RPT193 to treat atopic dermatitis
or other inflammatory diseases. Detailed information regarding risk
factors that may cause actual results to differ materially from the
results expressed or implied by statements in this press release
may be found in RAPT’s Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission on August 11, 2021, and
subsequent filings made by RAPT with the Securities and Exchange
Commission. These forward-looking statements speak only as of the
date hereof. RAPT disclaims any obligation to update these
forward-looking statements.
Investor Contact:Sylvia
Wheelerswheeler@wheelhouselsa.com
Media Contact:Aljanae
Reynoldsareynolds@wheelhouselsa.com
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