Infinity Pharmaceuticals, Inc. INFI today announced that ASPIRA, a Phase 2 study of duvelisib, an oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, with background methotrexate in patients with moderate-to-severe rheumatoid arthritis (RA) did not meet its primary endpoint. The primary endpoint was the ACR20 response rate at 12 weeks, which is defined as the proportion of patients who achieve at least a 20 percent improvement in American College of Rheumatology (ACR) response criteria after 12 weeks of study treatment.
Infinity will not proceed with any further clinical development of its PI3K inhibitors in rheumatoid arthritis. Infinity is continuing to focus on advancing duvelisib for the treatment of blood cancers and is conducting registration-focused studies of duvelisib in indolent non-Hodgkin lymphoma and chronic lymphocytic leukemia, forms of blood cancer for which there are no cures.
Study Details
This Phase 2, double-blind, randomized,
placebo-controlled study was designed to evaluate the efficacy, safety
and pharmacokinetics of duvelisib dosed at either 0.5 mg, 1.0 mg or 5.0
mg twice daily (BID) for 12 weeks with background methotrexate compared
to treatment with placebo plus methotrexate. The study evaluated 322
adults with active moderate-to-severe RA receiving a stable dose of
methotrexate. The primary efficacy endpoint of the study was the ACR20
response rate at week 12.
An effect of duvelisib compared to placebo was not observed on the primary endpoint at any of the three dose levels tested. The majority of side effects observed were Grade 1-2, reversible or clinically manageable, and no new safety signals associated with duvelisib therapy were identified.
Infinity will continue to analyze the study results and expects to submit the data for publication in a peer-reviewed forum.
About Duvelisib
Duvelisib is an investigational inhibitor of
Class I phosophoinositide-3-kinase (PI3K)-delta and PI3K-gamma that is
being jointly developed by Infinity Pharmaceuticals, Inc. and AbbVie
Inc. in oncology. The PI3K pathway is known to play a critical role in
regulating the growth and survival of certain types of blood cancers.
Duvelisib is designed to block the growth and survival of tumor cells by
inhibiting PI3K-delta and PI3K-gamma signaling. The investigational
agent is being evaluated in registration-focused studies, including
DYNAMOTM, a Phase 2 study in patients with refractory
indolent non-Hodgkin lymphoma, DYNAMO+R, a Phase 3 study in patients
with previously treated follicular lymphoma, and DUOTM, a
Phase 3 study in patients with relapsed/refractory chronic lymphocytic
leukemia. Duvelisib is an investigational compound and its safety and
efficacy have not been evaluated by the U.S. Food and Drug
Administration or any other health authority.
About Infinity Pharmaceuticals, Inc.
Infinity is an
innovative biopharmaceutical company dedicated to discovering,
developing and delivering best-in-class medicines to people with
difficult-to-treat diseases. Infinity combines proven scientific
expertise with a passion for developing novel small molecule drugs that
target emerging disease pathways. For more information on Infinity,
please refer to the company's website at www.infi.com.
Forward-Looking Statements
This press release contains
forward-looking statements within the meaning of The Private Securities
Litigation Reform Act of 1995. Such forward-looking statements include
those regarding the Company's expectations about: its plans not to
proceed with further clinical development of PI3K inhibitors in
rheumatoid arthritis; publication plans for ASPIRA study results; its
ability to execute on its strategic plans; and the therapeutic potential
of PI3K inhibition and duvelisib. Such statements are subject to
numerous important factors, risks and uncertainties that may cause
actual events or results to differ materially from the company's current
expectations. For example, there can be no guarantee that Infinity will
report data in the time frames it has estimated, that any product
candidate Infinity is developing will successfully complete necessary
preclinical and clinical development phases, or that development of any
of Infinity's product candidates will continue. Further, there can be no
guarantee that Infinity's strategic collaboration with AbbVie will
continue or that any positive developments in Infinity's product
portfolio will result in stock price appreciation. Management's
expectations and, therefore, any forward-looking statements in this
press release could also be affected by risks and uncertainties relating
to a number of other factors, including the following: Infinity's
results of clinical trials and preclinical studies, including subsequent
analysis of existing data and new data received from ongoing and future
studies; a failure of Infinity and/or AbbVie to fully perform under the
strategic collaboration and/or an early termination of the collaboration
and license agreement; the content and timing of decisions made by the
U.S. FDA and other regulatory authorities, investigational review boards
at clinical trial sites and publication review bodies; Infinity's
ability to obtain and maintain requisite regulatory approvals and to
enroll patients in its clinical trials; unplanned cash requirements and
expenditures; development of agents by Infinity's competitors for
diseases in which Infinity is currently developing or intends to develop
its product candidates; and Infinity's ability to obtain, maintain and
enforce patent and other intellectual property protection for any
product candidates it is developing. These and other risks which may
impact management's expectations are described in greater detail under
the caption “Risk Factors” included in Infinity's quarterly report on
Form 10-Q filed with the Securities and Exchange Commission (SEC)
on November 10, 2014, and other filings filed by Infinity with the SEC.
Any forward-looking statements contained in this press release speak
only as of the date hereof, and Infinity expressly disclaims any
obligation to update any forward-looking statements, whether as a result
of new information, future events or otherwise.
Infinity Pharmaceuticals, Inc.
Jaren Irene Madden,
617-453-1336
Jaren.Madden@infi.com
http://www.infi.com
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