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 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). After four weeks of treatment, patients with
moderate-to-severe AD who received RPT193 showed a 36.3%
improvement from baseline in the Eczema Area and Severity Index
(EASI) score, a standard measure of disease severity, compared to
17.0% in the placebo group. Notably, in the two-week period
following the end of treatment, the RPT193 group showed continued
improvement and further separation from placebo with a 53.2%
improvement in EASI at the six-week time point compared to 9.6% in
the placebo group. This continued improvement may be related to
RPT193’s mechanism of action, which is upstream of other agents
targeting cytokines or signaling pathways.
“These data strongly support the potential of RPT193 as a safe,
once-daily, oral treatment for patients with atopic dermatitis
which would be an attractive therapeutic alternative ahead of
injectable drugs,” said Brian Wong, M.D., Ph.D., President and CEO
of RAPT Therapeutics. “We look forward to advancing RPT193 to a
Phase 2b trial in atopic dermatitis and a Phase 2a trial in
asthma.”Emma Guttman-Yassky, M.D., Ph.D., the Waldman Professor of
Dermatology and System Chair Department of Dermatology at the Icahn
School of Medicine at Mount Sinai, and member of RAPT’s Scientific
Advisory Board, added, “I am very excited about these results as
they not only demonstrate clinically meaningful improvement after
just four weeks of treatment, but also further improvement for two
weeks after completion of treatment. This may suggest that this
novel mechanism of action targeting CCR4 on Th2 cells could have
prolonged, disease-modifying effects, which could differentiate it
from other agents. Along with being an oral drug that seems to have
promising clinical activity and a well-tolerated safety
profile, RPT193 could fill a high unmet medical need for AD
patients.”
Key Findings from the Phase 1b StudyIn the
Phase 1b study, 21 patients with moderate-to-severe atopic
dermatitis were treated with 400 mg of RPT193, administered orally
once a day for four weeks, while 10 patients received placebo. The
RPT193 group showed clear improvement in key efficacy measures
compared to placebo at the end of the four-week treatment period,
including improvement in the Eczema Area and Severity Index (EASI)
score, validated Investigator Global Assessment (vIGA) and pruritis
Numerical Rating Scale (NRS):
- Patients treated with RPT193
achieved a 36.3% improvement in EASI score from baseline compared
with a 17.0% improvement in patients in the placebo group
- 42.9% of patients treated with
RPT193 achieved a 50% improvement in EASI score (EASI-50) compared
with 10.0% in the placebo group
- 4.8% of patients treated with
RPT193 achieved a vIGA score of 0/1 and at least a two-point
improvement over baseline compared with 0.0% in the placebo group;
and
- 45.0% of patients treated with
RPT193 achieved at least a four-point reduction in the pruritus NRS
score, compared with 22.2% in the placebo group
Patients were also evaluated for exploratory endpoints at six
weeks (two weeks after the end of treatment). At six weeks, the
patients treated with RPT193 showed further improvement in EASI
score and vIGA:
- Patients treated with RPT193
achieved a 53.2% improvement in EASI score from baseline compared
with a 9.6% improvement in patients in the placebo group
- 61.9% of patients treated with
RPT193 achieved EASI-50 compared with 20.0% in the placebo group;
and
- 14.3% of patients treated with
RPT193 achieved a vIGA score of 0/1 and at least a two-point
improvement over baseline compared with 0.0% in the placebo
group
Based on exploratory statistical analyses, the difference
between RPT193 and placebo on the percent change in EASI score and
EASI-50 was statistically significant at Day 43 (p < 0.05). No
other endpoints or timepoints achieved statistical
significance.
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. The overall safety profile of RPT193
to date, including the Phase 1b study and the previously reported
blinded safety data from our Phase 1a study in healthy volunteers,
suggests RPT193 is a well-tolerated oral drug that would not
require any laboratory safety monitoring.
In addition to the topline data reported today, RAPT intends to
report additional data and analyses in a future publication or at
an upcoming medical conference.Based on the efficacy and safety
data observed in the Phase 1b study, RAPT plans to initiate a
dose-ranging Phase 2b study in patients with moderate-to-severe AD
and is also planning a Phase 2a study in asthma.
About the Phase 1a/1b Study of RPT193The Phase
1b study reported today is part of RAPT’s first-in-human Phase
1a/1b trial of RPT193. The Phase 1b portion of the trial is 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 is safety. Secondary and
exploratory endpoints include pharmacokinetics, biomarkers and
clinical efficacy as evaluated by multiple measurements, including
percent change in the Eczema Area and Severity Index (EASI) score,
the validated Investigator Global Assessment (vIGA) and pruritis
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.
Conference call and webcast detailsRAPT will
host a conference call accompanied by a slide presentation today,
Monday, June 14, 2021, at 8:30 a.m. ET. The live webcast and audio
archive of the presentation is available on the RAPT Therapeutics
website at https://investors.rapt.com/events-and-presentations. The
call can be accessed by dialing (833) 672-0665 (domestic) or (929)
517-0344 (international) and referring to conference ID 4696044.
The webcast replay will be available for 30 days.
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.
Preliminary 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
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.
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 May 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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