Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced results
from the Company’s Phase 1A study in healthy volunteers evaluating
oral non-covalent BTK inhibitor SNS-062. The study demonstrated a
favorable safety, pharmacokinetic (PK) and pharmacodynamic (PD)
profile for SNS-062 in healthy subjects. The results were presented
on Saturday, September 10th at the European School of Haematology’s
(ESH) 2nd International Conference on New Concepts in B-Cell
Malignancies at the Estoril Congress Centre in Estoril, Portugal.
“Our first-in-human clinical results are
encouraging and reinforce our belief that SNS-062 has the potential
to become an important new treatment option for patients with
B-cell malignancies,” said Linda Neuman, M.D., Vice President,
Clinical Development of Sunesis. “Notably, SNS-062 exposure, even
at the lowest dose of 50 mg, exceeded those reported for both
ibrutinib and acalabrutinib at their respective recommended dose
levels, suggesting that SNS-062 has improved PK properties.
Furthermore, as a non-covalent BTK inhibitor with a distinct
binding profile, SNS-062 may overcome the acquired resistance to
ibrutinib and other covalent clinical-stage inhibitors resulting
from a point mutation (C481S) in the BTK active site.”
“The safety profile and the extent and duration
of BTK inhibition by SNS-062 support the timely advancement of this
program into cancer-directed studies,” said Daniel Swisher,
President and Chief Executive Officer of Sunesis. “We look forward
to moving SNS-062 into a planned Phase 1B/2 study of patients with
advanced B-cell malignancies.”
The reported data from this Phase 1A randomized,
double-blind, placebo-controlled, single-dose study are from four
sequential cohorts of 8 subjects each who were randomly assigned to
receive progressively higher single oral administrations of SNS-062
at doses of 50, 100, 200, and 300 mg (n=6 per cohort) or placebo
(n=2 per cohort). An evaluation of the effects of food and
CYP3A4 inhibition on the PK of SNS-062 is ongoing.
For the primary endpoint of safety,
investigators were blinded to treatment arm for assessment of
relatedness. Overall, AEs were reported for 8 (33%) subjects
who received SNS-062 and for 3 (38%) subjects who received placebo.
Treatment-related AEs were reported in 6/24 (25%) subjects who
received SNS-062 compared with 3/8 (38%) subjects who received
placebo. For patients who received SNS-062, treatment-related AEs
included headache, nausea, and supraventricular tachycardia. In the
placebo group, treatment-related AEs included headache, nausea, and
diarrhea. No obvious pattern of dose-dependent toxicity was
observed. All AEs were transient and low grade. None of the
AEs, laboratory abnormalities, or ECG or telemetry findings were
considered clinically meaningful. No SAEs were reported.
SNS-062 was rapidly absorbed and had mean plasma
half-life values across all dose cohorts of 7.4 to 17 hours.
SNS-062 concentrations declined in a multiphasic manner.
Total exposure (AUC and Cmax) increased proportionally with dose.
SNS-062 demonstrated rapid, profound (~100%), and prolonged
inhibition of BTK at all dose levels supporting a future
twice-daily dosing regimen.
The poster, titled “A Phase 1A Study to
Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of
the Noncovalent Bruton Tyrosine Kinase (BTK) Inhibitor SNS-062 in
Healthy Subjects: Preliminary Results” is available on the Sunesis
website at www.sunesis.com.
Conference Call and Webcast
InformationSunesis will host a conference call and slide
webcast today, Monday, September 12 at 8:00 a.m. Eastern
Time. The call can be accessed by dialing (844) 296-7720 (U.S.
and Canada) or (574) 990-1148 (international), and
entering passcode 70718677. To access the live audio webcast, or
the subsequent archived recording, visit the "Investors and Media -
Calendar of Events" section of the Sunesis website
at www.sunesis.com. The webcast will be recorded and available
for replay on the company's website for two weeks.
About SNS-062SNS-062 is a
novel, second-generation BTK inhibitor, a class of kinase
inhibitors that selectively inhibits the enzyme Bruton's
tyrosine kinase (BTK). This target mediates signaling through
the B-cell receptor, which is critical for adhesion, migration,
proliferation and survival of normal and malignant B-lineage
lymphoid cells. SNS-062’s favorable safety, pharmacokinetics,
potency, kinase selectivity and non-covalent binding profile
support the advancement to a Phase 1B/2 study in patients with
B-cell malignancies. This study will include patients with an
acquired resistance from a C481S mutation at the point in the
enzyme’s binding site required for covalent binding of ibrutinib
and other covalent inhibitors.
About Sunesis
PharmaceuticalsSunesis is a biopharmaceutical company
focused on the development and commercialization of new oncology
therapeutics for the potential treatment of solid and hematologic
cancers. Sunesis has built a highly experienced cancer drug
development organization committed to improving the lives of people
with cancer. Currently, the company is focused on pursuing
regulatory approval in Europe for its lead product
candidate, vosaroxin, for the treatment of relapsed or refractory
acute myeloid leukemia in patients aged 60 and older, as well as
advancing its novel kinase-inhibitor pipeline, which includes its
proprietary non-covalent BTK-inhibitor, SNS-062. For
additional information on Sunesis, please
visit http://www.sunesis.com.
SUNESIS and the logos are trademarks
of Sunesis Pharmaceuticals, Inc.
This press release contains forward-looking
statements, including statements related to Sunesis' corporate
objectives, including the clinical development of SNS-062 and
potential approval of vosaroxin by the EMA. Words such as “belief,”
“look forward,” “may,” “planned,” "potential," "will" and similar
expressions are intended to identify forward-looking statements.
These forward-looking statements are based upon Sunesis' current
expectations. Forward-looking statements involve risks and
uncertainties. Sunesis' actual results and the timing of events
could differ materially from those anticipated in such
forward-looking statements as a result of these risks and
uncertainties, which include, without limitation, the risk that
Sunesis' clinical studies for SNS-062, vosaroxin or other product
candidates, including its pipeline of kinase inhibitors, may not
demonstrate safety or efficacy or lead to regulatory approval, the
risk that data to date and trends may not be predictive of future
data or results, risks related to the conduct of Sunesis' clinical
trials, the risk that Sunesis may not be able to receive regulatory
approval of vosaroxin in the U.S. or Europe, that Sunesis'
development activities for vosaroxin could be otherwise halted or
significantly delayed for various reasons, risks related to
Sunesis' need for substantial additional funding to complete the
development and commercialization of vosaroxin and other product
candidates, and risks related to Sunesis' ability to raise the
capital that it believes to be accessible and is required to fully
finance the development and commercialization of vosaroxin and
other product candidates. These and other risk factors are
discussed under "Risk Factors" and elsewhere in Sunesis' Annual
Report on Form 10-K for the year ended December 31, 2015,
Sunesis’ Quarterly Report on Form 10-Q for the quarter
ended June 30, 2016, and Sunesis' other filings with
the Securities and Exchange Commission. Sunesis
expressly disclaims any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements
contained herein to reflect any change in Sunesis' expectations
with regard thereto or any change in events, conditions or
circumstances on which any such statements are based.
Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
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