Rib-X Pharmaceuticals, Inc. initiates Phase 2 Trial for RX-3341 in Complicated Skin and Skin Structure Infections
— Studies to investigate safety and efficacy in treatment of multi-drug resistant infections
New Haven, Connecticut. July 15, 2008 — Rib-X Pharmaceuticals, Inc.,
a development stage company focused on the discovery and development of novel
antibiotics for the treatment of antibiotic resistant infections, today announced
the initiation of a Phase 2 clinical trial for an intravenous form of antibiotic compound
RX-3341 in the treatment of complicated skin and skin structure infections (cSSSIs).
The safety and efficacy study will be conducted at 35 sites across the United States.
As a precursor to this news the Company also announced positive results of a two-part
Phase 1 study with the same candidate.
"We have made significant progress in advancing this next generation broad spectrum antibiotic further toward clinical use," said Dr. Susan Froshauer, President and Chief Executive Officer of Rib-X. "We intend to rapidly move forward with the development of our intravenous dosage form to meet the need for a broad spectrum antibiotic in the hospital setting, particularly one that is active against quinolone resistant MRSA. We also hope to further progress our oral dosage form to ensure a greater diversity of use in the treatment of serious infections in a number of settings."
Part 2 of the study was designed to assess the safety, tolerability and pharmacokinetics of the optimized intravenous RX-3341 formulation. Results showed that the chosen intravenous RX-3341 formulation was well tolerated using multiple doses for 14 days.
About Rib-X Pharmaceuticals
Rib-X Pharmaceuticals, Inc. is a product driven small molecule drug discovery and development company focused on the structure based design of new classes of antibiotics. The Company's underlying drug discovery engine capitalizes on its proprietary high-resolution crystal structure of the ribosome, which performs an essential role in the fundamental process of protein synthesis. Many known, commercially valuable antibiotics bind to the ribosome, including those used to treat both community acquired and hospital acquired pathogens. The Company's integrated research strategy, which combines state-of-the-art, proprietary computational analysis, X-ray crystallography, medicinal chemistry, microbiology, and biochemistry, allows it to rapidly synthesize new agents designed to avoid typical antibiotic resistance mechanisms. Rib-X's iterative intelligent engine has yielded several distinctive new antibiotic classes. The Company currently has two programs in human clinical trials, the radezolid (RX-1741) designer oxazolidinone program as an oral/IV agent to treat serious hospital Gram-positive infections and the delafloxacin, (RX-3341) program, a next generation fluoroquinolone, active against a broad spectrum of bacteria, including methicillin resistant Staphylococcus aureus. Additionally, the Company has multiple drug discovery programs. The first of these is an exciting discovery program that is well on its way toward the identification of new chemical classes of antibiotics active against multi-drug resistant Gram-negative bacteria in the hospital. The second of these programs is focused on design and development of an IV and orally active macrolide for treatment of infections in the nursing home and hospital setting, including those caused by MRSA and enterococci. Radezolid and the multiple discovery programs derive from Rib-X's proprietary use of the ribosome structure and computational tools.
"We have made significant progress in advancing this next generation broad spectrum antibiotic further toward clinical use," said Dr. Susan Froshauer, President and Chief Executive Officer of Rib-X. "We intend to rapidly move forward with the development of our intravenous dosage form to meet the need for a broad spectrum antibiotic in the hospital setting, particularly one that is active against quinolone resistant MRSA. We also hope to further progress our oral dosage form to ensure a greater diversity of use in the treatment of serious infections in a number of settings."
Phase 2 Study Design
This Phase 2 double-blind study (study RX-3341-201) will evaluate the safety and efficacy of
RX-3341 at two different doses administered intravenously to hospitalized cSSSI patients every
12 hours for 5 to 14 days, as compared to tigecycline (Tygacil®). The study's primary endpoint
is the assessment of RX-3341 efficacy, safety and tolerability at the two different doses compared
to that of tigecycline's standard dosing regimen. A secondary endpoint for the study is the
assessment of clinical efficacy of RX-3341 compared to tigecycline in patients with cSSSIs caused
by methicillin resistant
Staphylococcus aureus
(MRSA).
Phase I Results
The two-part Phase 1 study (RX-3341-103) compared the safety, tolerability and pharmacokinetics
of two intravenous formulations of RX-3341. Part 1 of the study was designed to compare the safety
and pharmacokinetics of the two intravenous (IV) formulations, with the purpose of optimizing the
formulation of the IV dosage form. Twelve individuals received one dose of each of the formulations
in a crossover design. The two formulations were thus shown to be comparable in terms of exposure.
Part 2 of the study was designed to assess the safety, tolerability and pharmacokinetics of the optimized intravenous RX-3341 formulation. Results showed that the chosen intravenous RX-3341 formulation was well tolerated using multiple doses for 14 days.
About RX-3341
RX-3341 is a novel, broad spectrum fluoroquinolone antibiotic which has shown increased activity
against Gram-positive organisms compared to other quinolones, and similar or better activity to
that of ciprofloxacin against Gram-negative organisms in
in vitro
studies and twelve Phase 1 and two Phase 2 clinical trials of the oral dosage form.
About Rib-X Pharmaceuticals
Rib-X Pharmaceuticals, Inc. is a product driven small molecule drug discovery and development company focused on the structure based design of new classes of antibiotics. The Company's underlying drug discovery engine capitalizes on its proprietary high-resolution crystal structure of the ribosome, which performs an essential role in the fundamental process of protein synthesis. Many known, commercially valuable antibiotics bind to the ribosome, including those used to treat both community acquired and hospital acquired pathogens. The Company's integrated research strategy, which combines state-of-the-art, proprietary computational analysis, X-ray crystallography, medicinal chemistry, microbiology, and biochemistry, allows it to rapidly synthesize new agents designed to avoid typical antibiotic resistance mechanisms. Rib-X's iterative intelligent engine has yielded several distinctive new antibiotic classes. The Company currently has two programs in human clinical trials, the radezolid (RX-1741) designer oxazolidinone program as an oral/IV agent to treat serious hospital Gram-positive infections and the delafloxacin, (RX-3341) program, a next generation fluoroquinolone, active against a broad spectrum of bacteria, including methicillin resistant Staphylococcus aureus. Additionally, the Company has multiple drug discovery programs. The first of these is an exciting discovery program that is well on its way toward the identification of new chemical classes of antibiotics active against multi-drug resistant Gram-negative bacteria in the hospital. The second of these programs is focused on design and development of an IV and orally active macrolide for treatment of infections in the nursing home and hospital setting, including those caused by MRSA and enterococci. Radezolid and the multiple discovery programs derive from Rib-X's proprietary use of the ribosome structure and computational tools.
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Gina Nugent
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