Keros Therapeutics Announces Preliminary Topline Results from its Ongoing Phase 1 Clinical Trial Evaluating KER-012 in Healthy Volunteers
18 May 2022 - 8:00PM
Keros Therapeutics, Inc. (“Keros”) (Nasdaq: KROS), a clinical-stage
biopharmaceutical company focused on the discovery, development and
commercialization of novel treatments for patients suffering from
hematological and musculoskeletal disorders with high unmet medical
need, today announced preliminary topline results from Part 1 of
its Phase 1 clinical trial evaluating single and multiple ascending
doses of KER-012 in healthy postmenopausal volunteers.
The ongoing trial is designed as a randomized, double-blind,
placebo-controlled, two-part trial to assess the safety,
tolerability and pharmacokinetics of KER-012. In Part 1 of this
ongoing trial, 32 subjects received either a single 0.75, 1.5, 3 or
5 mg/kg dose of KER-012 and eight subjects received a single dose
of placebo, each administered subcutaneously with an eight-week
safety follow-up. The subjects were enrolled in sequential
single-ascending dose escalation cohorts of ten subjects each.
KER-012 was generally well tolerated in Part 1 of this trial at
dose levels up to 5 mg/kg, the highest dose level tested, when
administered as a single dose. While one subject withdrew consent
after receiving a single 1.5 mg/kg dose of KER-012 and did not
complete the safety follow-up, there were no discontinuations due
to treatment-related adverse events in Part 1 of this trial. No
serious adverse events were reported in Part 1 of this trial.
Additionally, the majority of the adverse events that were observed
in Part 1 of this trial were mild in severity.
Preliminary topline results from Part 1 of this trial include
the following:
- Pharmacokinetic parameters were observed to be generally dose
proportional with increasing doses.
- Maximal target engagement was observed following a single 5
mg/kg dose of KER-012, with a mean (standard deviation, “SD”) 39.6
(12.7)% reduction in follicle-stimulating hormone levels observed
on Day 22.
- Robust increases in markers of bone formation were observed:
- Bone specific alkaline phosphatase increased, starting at the
lowest dose of 0.75 mg/kg, with mean (SD) maximum increases from
baseline of 36.4 (4.0)% at the highest dose of 5 mg/kg.
- No clinically meaningful changes in red blood cells or
hemoglobin were observed in Part 1 of this trial.
“We are pleased to report the preliminary topline findings from
Part 1 of the Phase 1 clinical trial in KER-012, as we observed
target engagement and changes in bone remodeling markers consistent
with the restoration of signaling of the bone morphogenetic protein
(“BMP”) pathway, with no clinically meaningful observed changes in
red blood cells or hemoglobin,” said Jasbir S. Seehra, Ph.D.,
President and Chief Executive Officer of Keros. “We believe these
results support the potential of KER-012 as a treatment for
diseases that are associated with reduced BMP signaling, such as
pulmonary arterial hypertension (“PAH”), without a potentially
dose-limiting red blood cell effect.”
Part 2 of this trial is ongoing, with dosing for Cohort 3 of
Part 2 initiated at 4.5 mg/kg of KER-012, to be administered once
every four weeks for three doses. Keros expects to report data from
Part 2 of this trial in the second half of 2022.
Following the completion of this Phase 1 clinical trial, Keros
expects to initiate a Phase 2 clinical trial of KER-012 in patients
with PAH, and expects to share the trial design for the Phase 2
clinical trial in early 2023.
Conference Call and Webcast
Keros will host a conference call and webcast today, May 18,
2022 at 8:00 a.m. Eastern time to discuss the topline results from
Part 1 of the KER-012 Phase 1 clinical trial. The conference call
will be webcast live at
https://event.webcasts.com/starthere.jsp?ei=1548072&tp_key=90cb438f4c.
The live teleconference may be accessed by dialing (877) 405-1224
(domestic) or (201) 389-0848 (international). An archived version
of the call will be available in the Investors section of the Keros
website at https://ir.kerostx.com/ for 90 days following the
conclusion of the call.
About KER-012
KER-012 is designed to bind to and inhibit the signaling of
TGF-ß ligands that suppress bone growth, including activin A and
activin B. Keros believes that KER-012 has the potential to
increase the signaling of BMP pathways through this inhibition of
activin A and activin B signaling, and consequently treat diseases
such as PAH that are associated with reduced BMP signaling due to
inactivating mutations in the BMP receptors. KER-012 is being
developed for the treatment of PAH and for the treatment of
disorders associated with bone loss, such as osteogenesis
imperfecta and osteoporosis.
About Keros Therapeutics, Inc.
Keros is a clinical-stage biopharmaceutical company focused on
the discovery, development and commercialization of novel
treatments for patients suffering from hematologic and
musculoskeletal disorders with high unmet medical need. Keros is a
leader in understanding the role of the transforming growth
factor-beta family of proteins, which are master regulators of red
blood cell and platelet production as well as of the growth, repair
and maintenance of muscle and bone. Keros’ lead protein therapeutic
product candidate, KER-050, is being developed for the treatment of
low blood cell counts, or cytopenias, including anemia and
thrombocytopenia, in patients with myelodysplastic syndromes and in
patients with myelofibrosis. Keros’ lead small molecule product
candidate, KER-047, is being developed for the treatment of anemia
resulting from iron imbalance. Keros’ third product candidate,
KER-012, is being developed for the treatment of PAH and for the
treatment of disorders associated with bone loss, such as
osteoporosis and osteogenesis imperfecta.
Cautionary Note Regarding Forward-Looking
Statements
Statements contained in this press release regarding matters
that are not historical facts are “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act
of 1995, as amended. Words such as "anticipates," "believes,"
"expects," "intends," “plans,” “potential,” "projects,” “would” and
"future" or similar expressions are intended to identify
forward-looking statements. Examples of these forward-looking
statements include statements concerning: Keros’ expectations
regarding its growth, strategy, progress and the design, objectives
and timing of its clinical trials for KER-012; and the potential of
KER-012 to treat diseases such as PAH without a dose-limiting red
blood cell effect. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. These
risks and uncertainties include, among others: Keros’ limited
operating history and historical losses; Keros’ ability to raise
additional funding to complete the development and any
commercialization of its product candidates; Keros’ dependence on
the success of its lead product candidates, KER-050 and KER-047;
that Keros may be delayed in initiating, enrolling or completing
any clinical trials; competition from third parties that are
developing products for similar uses; Keros’ ability to obtain,
maintain and protect its intellectual property; Keros’ dependence
on third parties in connection with manufacturing, clinical trials
and pre-clinical studies; and risks relating to the impact on our
business of the COVID-19 pandemic or similar public health
crises.
These and other risks are described more fully in Keros’ filings
with the Securities and Exchange Commission (“SEC”), including the
“Risk Factors” section of the Company’s Quarterly Report on Form
10-Q, filed with the SEC on May 5, 2022, and its other documents
subsequently filed with or furnished to the SEC. All
forward-looking statements contained in this press release speak
only as of the date on which they were made. Except to the extent
required by law, Keros undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made.
Investor Contact:
Justin Frantzjfrantz@soleburytrout.com617-221-9100
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