Oruka Therapeutics Announces First Participants Dosed in Phase 1 Trial of ORKA-001, its Novel Half-life Extended Anti-IL-23p19 Antibody
19 Dezembro 2024 - 9:00AM
Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a biotechnology
company developing novel biologics designed to set a new standard
for the treatment of chronic skin diseases including plaque
psoriasis, today announced that it has initiated dosing of healthy
volunteers in its first clinical trial of ORKA-001, the Company’s
novel, subcutaneously administered, half-life extended monoclonal
antibody targeting IL-23p19.
“The initiation of this Phase 1 study of ORKA-001 marks an
important milestone for Oruka, which our team has delivered ahead
of schedule,” said Lawrence Klein, PhD, Chief Executive Officer of
Oruka. “We look forward to sharing initial data for ORKA-001 in the
second half of 2025, which could validate ORKA-001’s half-life and
safety profile, supporting extended dosing intervals and
best-in-class potential.”
The ORKA-001 Phase 1 trial is a double-blind,
placebo-controlled, single ascending dose study evaluating the
safety, tolerability, and pharmacokinetics (PK) of ORKA-001 in
healthy volunteers. The study is expected to enroll approximately
24 healthy volunteers across three subcutaneous dose cohorts. Oruka
expects to share interim data from this study in the second half of
2025.
Pending data from the Phase 1 trial, Oruka plans to initiate a
proof-of-concept study of ORKA-001 in moderate-to-severe psoriasis
in the second half of 2025. This study is anticipated to evaluate
the safety and efficacy of a single dose level of ORKA-001 versus
placebo in approximately 80 subjects, followed by randomization to
one of two maintenance dosing arms. In one maintenance arm,
subjects will receive ORKA-001 every six months. In the other,
subjects will receive only induction dosing to assess the length of
time patients maintain clear skin, which could support once-yearly
dosing or even longer-term durability in some patients. Subjects
then can continue to an open-label extension study. The company
expects to share initial data from the proof-of concept study in
the second half of 2026.
“We believe that ORKA-001 has the potential to set a new
standard in the treatment of plaque psoriasis in terms of both
depth and duration of response,” said Joana Goncalves, MBChB, Chief
Medical Officer of Oruka. “We hear consistently that people with
psoriasis want to achieve freedom from their disease, and that is
what we hope to offer with this program. The initiation of this
Phase 1 study brings us one step closer to that goal.”
Additionally, the Company announced that it has entered into a
license agreement with Paragon Therapeutics granting it worldwide
exclusive rights to ORKA-001 in all indications other than
inflammatory bowel disease.
About ORKA-001
ORKA-001 is a novel, subcutaneously administered, half-life
extended monoclonal antibody targeting IL-23p19. Inhibitors of
IL-23p19 have become the preferred first-line therapy for patients
with moderate-to-severe PsO given their strong efficacy and safety
profile. Currently approved therapies are dosed four to six times
per year and deliver PASI 100, or fully clear skin, for less than
half of patients after four months. ORKA-001 has the potential to
be dosed just once or twice a year and is designed to achieve
higher exposures than currently marketed IL-23p19 antibodies, which
could lead to higher rates of disease clearance. Data from studies
in non-human primates and other preclinical assays show that
ORKA-001 binds to a similar epitope with similar affinity as
risankizumab and has a significantly extended half-life over three
times longer than risankizumab.
About Oruka Therapeutics
Oruka Therapeutics is developing novel biologics designed to set
a new standard for the treatment of chronic skin diseases. Oruka’s
mission is to offer patients suffering from chronic skin diseases
like plaque psoriasis the greatest possible freedom from their
condition by achieving high rates of complete disease clearance
with dosing as infrequently as once or twice a year. Oruka is
advancing a proprietary portfolio of potentially best-in-class
antibodies that were engineered by Paragon Therapeutics and target
the core mechanisms underlying plaque psoriasis and other
dermatologic and inflammatory diseases. For more information, visit
www.orukatx.com and follow Oruka on LinkedIn.
Forward Looking Statements
Certain statements in this press release, other than purely
historical information, may constitute “forward-looking statements”
within the meaning of the federal securities laws, including for
purposes of the safe harbor provisions under the United States
Private Securities Litigation Reform Act of 1995. These
forward-looking statements include, but are not limited to, express
or implied statements relating to Oruka’s expectations, hopes,
beliefs, intentions or strategies regarding the future of its
pipeline and business including, without limitation, Oruka’s
ability to achieve the expected benefits or opportunities with
respect to ORKA-001, including timelines to clinical and data
release milestones, the details of its proof of concept study and
the potential half-life of ORKA-001 and its potential dosing
interval. These forward-looking statements are based on current
expectations and beliefs concerning future developments and their
potential effects. There can be no assurance that future
developments affecting Oruka will be those that have been
anticipated. These forward-looking statements involve a number of
risks, uncertainties (some of which are beyond Oruka's control) or
other assumptions that may cause actual results or performance to
be materially different from those expressed or implied by these
forward-looking statements. These risks and uncertainties include,
but are not limited to, those uncertainties and factors described
under the heading “Risk Factors” and “Cautionary Note Regarding
Forward-Looking Statements” in Oruka’s most recent filings with the
Securities and Exchange Commission (SEC), including its
registration statement on Form S-1 and its Quarterly Reports on
Form 10-Q. Should one or more of these risks or uncertainties
materialize, or should any of Oruka’s assumptions prove incorrect,
actual results may vary in material respects from those projected
in these forward-looking statements. Nothing in this press release
should be regarded as a representation by any person that the
forward-looking statements set forth therein will be achieved or
that any of the contemplated results of such forward-looking
statements will be achieved. You should not place undue reliance on
forward-looking statements in this press release, which speak only
as of the date they are made and are qualified in their entirety by
reference to the cautionary statements herein and in Oruka’s SEC
filings. Oruka does not undertake or accept any duty to make any
updates or revisions to any forward-looking statements.
Investor Contact:Alan
Lada(650)-606-7911alan.lada@orukatx.com
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