Ligand Partner Melinta Therapeutics Reports Positive Phase 3 Results for Captisol-enabled™ Delafloxacin IV
SAN DIEGO--
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced
today that its partner Melinta Therapeutics reported positive top-line
results from the first of two Phase 3 PROCEED studies (study
RX-3341-302, NCT01811732) to evaluate delafloxacin, an investigational
fluoroquinolone, compared with vancomycin + aztreonam for the treatment
of patients with acute bacterial skin and skin structure infections
(ABSSSI). Delafloxacin met the study’s primary objective endpoint of a
reduction in the measurement of lesion erythema at the primary infection
site at 48- to- 72 hours, the endpoint required by the U.S. Food and
Drug Administration (FDA). Delafloxacin also was comparable to
vancomycin in the study’s secondary endpoints, including investigator
assessment of signs and symptoms of infection at the follow-up visit, a
metric required by the European Medicines Agency (EMA).
“Our partners at Melinta Therapeutics continue to make great progress
advancing Captisol-enabled Delafloxacin IV,” said John Higgins, Ligand’s
President and Chief Executive Officer. “We congratulate them on these
positive results as they move delafloxacin toward the market to treat
serious, often life-threatening infections. Captisol-enabled drugs
continue to show great promise in a variety of therapy areas that have
major global unmet medical need, including infectious diseases,
oncology, CNS, emergency care and others.”
Melinta reports that delafloxacin was shown to be well tolerated among
study participants. Mild gastrointestinal symptoms were the most common
treatment-related adverse events reported for delafloxacin, and rarely
led to study discontinuation. Melinta expects to make complete results
from this study available as a presentation at an upcoming medical
meeting and a publication in a peer-reviewed medical journal.
About the PROCEED Studies
The PROCEED studies for ABSSSI (studies 302 and 303) are Phase 3,
multicenter, randomized, double-blind, active-controlled studies to
evaluate delafloxacin compared with vancomycin + aztreonam for the
treatment of patients with ABSSSI. The studies’ primary endpoints are
change in the area measurements of lesion erythema at the primary
infection site at 48- to 72- hours. Secondary measures included the
objective response using reduction of erythema of ≥30% at 48- to- 72
hours; and investigator-assessed response of signs and symptoms of
infection at the day-28 follow-up visit in the overall study population.
Enrollment continues in the second confirmatory Phase 3 PROCEED study
(study RX-3341-303 NCT01984684) in patients with ABSSSI. Melinta
anticipates that top-line results from study 303 will be available in
the second half of 2015. The two studies are designed to support a U.S.
FDA New Drug Application (NDA).
About Delafloxacin
Delafloxacin is an investigational fluoroquinolone antibiotic currently
in Phase 3 clinical development for acute bacterial skin and skin
structure infections (ABSSSI). The PROCEED studies (studies 302 and 303)
are Phase 3, multicenter, randomized, double-blind, active-controlled
trials to evaluate delafloxacin compared with vancomycin + aztreonam for
the treatment of patients with acute bacterial skin and skin structure
infections.
About Melinta Therapeutics
Melinta Therapeutics, Inc. is dedicated to the discovery, development
and commercialization of groundbreaking antibiotics to overcome
drug-resistant, life-threatening infections. The need for new therapies
for drug-resistant infections is widely recognized as one of the most
serious public health issues facing the world today. To meet this need,
Melinta Therapeutics is rapidly progressing its late-stage
investigational antibiotic, delafloxacin, which is currently in Phase 3
development for acute bacterial skin and skin structure infections
(ABSSSI). Delafloxacin has been designated a qualified infectious
disease product (QIDP) for both ABSSSI and community-acquired bacterial
pneumonia by the U.S. Food and Drug Administration. A key initiative at
Melinta is to develop, through the application of Nobel Prize-winning
science, a new class of antibiotics designed to overcome the
drug-resistant ESKAPE pathogens known to cause serious hospital
infections. Melinta Therapeutics is privately held and backed by lead
investor Vatera Healthcare Partners among other private investors. The
company is headquartered in New Haven, CT with offices in Lincolnshire,
IL. Visit www.melinta.com
for more information.
About Captisol®
Captisol is a patent-protected, chemically modified cyclodextrin with a
structure designed to optimize the solubility and stability of drugs.
Captisol was invented and initially developed by scientists in the
laboratories of Dr. Valentino Stella at the University of Kansas’
Higuchi Biosciences Center for specific use in drug development and
formulation. This unique technology has enabled six FDA-approved
products, including Onyx Pharmaceuticals’ Kyprolis®, Baxter
International’s Nexterone® and Merck’s NOXAFIL IV. There are more than
30 Captisol-enabled products currently in clinical development.
About Ligand Pharmaceuticals
Ligand is a biopharmaceutical company with a business model that is
based upon the concept of developing or acquiring royalty revenue
generating assets and coupling them to a lean corporate cost structure.
Ligand’s goal is to produce a bottom line that supports a sustainably
profitable business. By diversifying the portfolio of assets across
numerous technology types, therapeutic areas, drug targets and industry
partners, we offer investors an opportunity to invest in the
increasingly complicated and unpredictable pharmaceutical industry. In
comparison to its peers, we believe Ligand has assembled one of the
largest and most diversified asset portfolios in the industry with the
potential to generate revenue in the future. These therapies seek to
address the unmet medical needs of patients for a broad spectrum of
diseases including diabetes, hepatitis, muscle wasting, Alzheimer's
disease, dyslipidemia, anemia, asthma and osteoporosis. Ligand’s
Captisol platform technology is a patent-protected, chemically modified
cyclodextrin with a structure designed to optimize the solubility and
stability of drugs. Ligand has established multiple alliances with the
world's leading pharmaceutical companies including GlaxoSmithKline, Onyx
Pharmaceuticals (a subsidiary of Amgen Inc.), Merck, Pfizer, Baxter
International, Lundbeck Inc., Eli Lilly & Co. and Spectrum
Pharmaceuticals. Please visit www.captisol.com
for more information on Captisol and www.ligand.com
for more information on Ligand.
Forward-Looking Statements
This news release contains certain forward-looking statements by Ligand
that involve risks and uncertainties and reflect Ligand's judgment as of
the date of this release. These statements include those related to
Captisol-enabled IV formulation of delafloxacin, Melinta Therapeutics,
Inc., and Ligand’s business model and portfolio of partnered programs.
Actual events or results may differ from our expectations. For example,
there can be no assurance that Captisol-enabled IV formulation of
delafloxacin will progress through clinical development or receive
required regulatory approvals within the expected timelines or at all,
that further clinical trials will confirm any safety or other
characteristics or profile, that there will be a market of any size for
it or that it will be beneficial to patients or successfully marketed.
The failure to meet expectations with respect to any of the foregoing
matters may have a negative effect on Ligand's stock price. Additional
information concerning these and other risk factors affecting Ligand's
business can be found in prior press releases available via www.ligand.com
as well as in Ligand's public periodic filings with the Securities and
Exchange Commission at www.sec.gov.
Ligand disclaims any intent or obligation to update these
forward-looking statements beyond the date of this release. This caution
is made under the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995.
Ligand Pharmaceuticals Incorporated
John Higgins, President and CEO
858-550-7500
investors@ligand.com
@Ligand_LGND
or
LHA
Bruce
Voss
310-691-7100
bvoss@lhai.com
@LHA_IR_PR
Source: Ligand Pharmaceuticals Incorporated
Released January 8, 2015