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Infinity Reports Phase 1 Data for IPI-145 at ACR/ARHP Supporting Development in Inflammatory Conditions



  Infinity Reports Phase 1 Data for IPI-145 at ACR/ARHP Supporting Development
  in Inflammatory Conditions

2012 ACR/ARHP Scientific Meeting

Business Wire

CAMBRIDGE, Mass. -- November 12, 2012

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced new data from
its completed Phase 1 study of IPI-145, the company’s potent, oral inhibitor
of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma. The data showed that
IPI-145 was well tolerated and demonstrated favorable pharmacokinetics
following administration of single and multiple doses in healthy adult
subjects. Infinity also presented data demonstrating the activity of IPI-145
in preclinical models of rheumatoid arthritis (RA). These findings were
presented at the American College of Rheumatology (ACR)/Association of
Rheumatology Health Professionals (ARHP) 2012 Annual Meeting held in
Washington, DC.

“These data show that IPI-145 is well tolerated in healthy subjects and
inhibits immune cell activation even at low doses,” stated Vito J. Palombella,
chief scientific officer at Infinity. “The profile of IPI-145 observed in this
Phase 1 trial, combined with our preclinical studies in inflammation, support
Phase 2 clinical development in patients with asthma and RA as well as other
potential inflammatory indications.”

The PI3Ks are a family of enzymes involved in multiple cellular functions,
such as cell proliferation and survival, metabolism, cell differentiation and
cellular trafficking.^1 PI3K-delta and -gamma, two isoforms of PI3K, are
necessary for adaptive and innate immunity, and the role of these enzymes in
various immune cells supports the development of IPI-145 for the treatment of
inflammatory disorders as well as hematologic malignancies.^2 Infinity
believes that IPI-145 is the only PI3K-delta and -gamma inhibitor currently in
clinical development.

Data Presented at ACR/ARHP

The Phase 1, double-blind, randomized, placebo-controlled trial of IPI-145 in
healthy adult subjects evaluated single doses of IPI-145 ranging from 1 mg to
30 mg. Multiple doses of IPI-145 ranging from 1 mg twice daily (BID) to 5 mg
BID for 14 days and 10 mg once daily (QD) for 14 days were also evaluated. In
addition, the effect of food on the pharmacokinetics of IPI-145 was studied.
One hundred six patients were enrolled in the Phase 1 trial.

New data presented at ACR/ARHP showed that IPI-145 was well tolerated at all
doses studied, with a favorable pharmacokinetic and pharmacodynamic profile.
Among subjects who received multiple doses of IPI-145 BID (N=36) or placebo
(N=12) for 14 days, the most common adverse events were related to blood draws
and protocol-associated procedures. The most common non-procedural adverse
events occurring in ≥2 subjects were headache (8% vs. 25% placebo), myalgia
(6% vs. 8% placebo) and nasopharyngitis (6% vs. 0% placebo). There were no
dose-related trends in adverse events. Additionally, there were no significant
findings in safety lab studies including standard hematological parameters
(e.g., hemoglobin, white blood cells, platelets), as well as chemistry
parameters (e.g., transaminases, bilirubin, alkaline phosphatase, glucose,
creatinine) or electrocardiograms.

Pharmacokinetic data showed that IPI-145 was rapidly absorbed, with a
dose-proportional increase in exposure. The half-life of IPI-145 following 14
days of dosing ranged from approximately seven to 12 hours, supporting BID
dosing in ongoing trials. The pharmacokinetics were not significantly altered
by the consumption of a high-fat, high-calorie meal, suggesting that IPI-145
can be administered with or without food. In addition, an ex vivo
pharmacodynamic assay demonstrated rapid, dose dependent and durable
inhibition of basophil activation at all dose levels.

Infinity also presented preclinical data with IPI-145 in two models of RA. In
both models, IPI-145 showed dose-dependent activity, inhibiting ankle swelling
and protecting bone and cartilage in the joints of diseased animals.

The poster, “The Potent Phosphoinositide-3-Kinase(δ,γ) Inhibitor IPI-145 Is
Active in Preclinical Models of Arthritis and Well-Tolerated in Healthy Adult
Subjects,” may be found in the Publications Archive on Infinity’s website
http://www.infi.com/product-candidates-publications.asp.

About Infinity’s PI3K Program

IPI-145 is a potent, oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta
and PI3K-gamma. IPI-145 is the only PI3K-delta and -gamma inhibitor in
clinical development. Targeting PI3K-delta and -gamma may provide multiple
opportunities to develop differentiated therapies against inflammatory
diseases as well as hematologic malignancies. A Phase 2a, randomized,
double-blind, placebo-controlled, multi-dose, cross-over study of IPI-145 in
patients with asthma is under way, and Infinity is planning a Phase 2 trial of
IPI-145 in RA. Infinity is also conducting a Phase 1 open-label,
dose-escalation study of IPI-145 in patients with advanced hematologic
malignancies. On December 10, 2012, researchers will present initial data from
the Phase 1 trial of IPI-145 in hematologic malignancies at the 54^th American
Society of Hematology (ASH) Annual Meeting and Exhibition being held in
Atlanta, Georgia. Infinity also has an active discovery effort under way to
identify next-generation, isoform-specific PI3K inhibitors.

About Infinity Pharmaceuticals, Inc.

Infinity is an innovative drug discovery and development company seeking to
discover, develop and deliver to patients best-in-class medicines for diseases
with significant unmet need. Infinity combines proven scientific expertise
with a passion for developing novel small molecule drugs that target emerging
disease pathways. Infinity’s programs focused on the inhibition of
phosphoinositide-3-kinase and heat shock protein 90 are evidence of its
innovative approach to drug discovery and development. 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 therapeutic potential of and potential
clinical development plans for IPI-145. 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 timeframes 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 any positive
developments in Infinity’s product portfolio will result in stock price
appreciation. Management’s expectations could also be affected by risks and
uncertainties relating to: Infinity’s results of clinical trials and
preclinical studies, including subsequent analysis of existing data and new
data received from ongoing and future studies; 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 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
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 Annual Report on Form 10-K for the year ended December
31, 2011 and subsequent filings filed by Infinity with the Securities and
Exchange Commission. 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.

^1 Weinberg RA (2007) Cytoplasmic signaling circuitry programs many of the
traits of cancer. In Jeffcock E, Zayatz E, and Mickey RK (Eds.) The biology of
cancer (pp. 179-183). New York, NY: Garland Science, Taylor & Francis Group.

^2 Rommel C (2011) Taking PI3Kδ and PI3Kγ one step ahead: dual active PI3Kδ/γ
inhibitors for the treatment of immune-mediated inflammatory diseases. In
Rommel C, Vanhaesebroeck B, and Vogt PK, (Eds.) Phosphoinositide 3-kinase in
Health and Disease (pp. 279-299). Springer Berlin Heidelberg.

Contact:

Infinity Pharmaceuticals, Inc.
Jaren Irene Madden, 617-453-1336
Jaren.Madden@infi.com
http://www.infi.com
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