Rib-X Pharmaceuticals, Inc. Initiates Two Phase 2 Studies for Novel Antibiotic Compound RX-1741
— Studies to investigate safety and efficacy in treatment of multi-drug resistant infections
New Haven, Connecticut. January 4, 2008 — Rib-X Pharmaceuticals, Inc.,
a biopharmaceutical company focused on
the development of novel antibiotics for the treatment of
antibiotic resistant infections, today announced the enrolment of
the first patients in two separate Phase 2 clinical trials.
The studies will evaluate the safety and efficacy of RX-1741 in
the treatment of Community Acquired Pneumonia (CAP), and separately
in the outpatient treatment of uncomplicated Skin and Skin Structure
Infections (uSSSI). RX-1741 is the Company’s first antibiotic program
developed using its proprietary technology platform.
RX-1741 is an oxazolidinone antibiotic that exhibits activity against methicillin resistant Staphylococcus aureus (MRSA) and other Gram-positive organisms, and has demonstrated both greater spectrum and potency of activity than the currently marketed product of the same class, Zyvox® (linezolid). Discovered using proprietary knowledge of the three-dimensional structure of a key area of the ribosome, the 50S subunit, Rib-X believes that RX-1741 will demonstrate a high level of effectiveness against resistant microbes.
"These two studies represent important milestones for Rib-X," said Dr. Susan Froshauer, President and Chief Executive Officer of Rib-X. "RX-1741 is the first of many compounds that Rib-X intends to design and develop in response to the alarming growth of drug resistant microbial pathogens found both in the hospital and in the community. This MRSA-active agent will satisfy a critical need for physicians and their patients because current treatment options are very limited, particularly for orally active agents," said Dr. Froshauer.
CAP Study Design
The CAP study is a Phase 2, multicenter, randomized, double-blind study designed to evaluate the safety and efficacy of RX-1741 in the treatment of adult patients with mild to moderate severity of Community Acquired Pneumonia (CAP). The study will assess the efficacy of three doses of RX-1741, either once or twice a day, for seven to 10 days in the treatment of adult patients with mild to moderate CAP. It will also evaluate the safety and tolerability profile of the three doses.
The CAP study will enroll approximately 160 patients in 40 study centers across the U.S., Canada, and Russia, and the Company expects to have preliminary data available when approximately 80 patients (50% of the planned patients) have completed the study. The Company intends to release data from all patients during the first half of 2008.
uSSSI Study Design
The uSSSI study is a Phase 2, multicenter, randomized, open-label, comparative study to evaluate the safety and efficacy of RX-1741 versus linezolid in the outpatient treatment of adult patients with uncomplicated Skin and Skin Structure Infections (uSSSI). The study will assess the efficacy of a single dose of RX-1741 given either once daily or twice daily compared to linezolid given twice daily for five to ten days in the treatment of ambulatory patients with uSSSI. It will also evaluate the safety and tolerability profile of these two doses compared to linezolid.
The uSSSI study will enroll approximately 150 patients in 25 study centers across the U.S. and the Company expects an interim analysis of the data to be performed when approximately 75 patients (50% of the planned patients) have completed the study. The Company intends to release data from all patients during the first half of 2008.
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.
RX-1741 is an oxazolidinone antibiotic that exhibits activity against methicillin resistant Staphylococcus aureus (MRSA) and other Gram-positive organisms, and has demonstrated both greater spectrum and potency of activity than the currently marketed product of the same class, Zyvox® (linezolid). Discovered using proprietary knowledge of the three-dimensional structure of a key area of the ribosome, the 50S subunit, Rib-X believes that RX-1741 will demonstrate a high level of effectiveness against resistant microbes.
"These two studies represent important milestones for Rib-X," said Dr. Susan Froshauer, President and Chief Executive Officer of Rib-X. "RX-1741 is the first of many compounds that Rib-X intends to design and develop in response to the alarming growth of drug resistant microbial pathogens found both in the hospital and in the community. This MRSA-active agent will satisfy a critical need for physicians and their patients because current treatment options are very limited, particularly for orally active agents," said Dr. Froshauer.
CAP Study Design
The CAP study is a Phase 2, multicenter, randomized, double-blind study designed to evaluate the safety and efficacy of RX-1741 in the treatment of adult patients with mild to moderate severity of Community Acquired Pneumonia (CAP). The study will assess the efficacy of three doses of RX-1741, either once or twice a day, for seven to 10 days in the treatment of adult patients with mild to moderate CAP. It will also evaluate the safety and tolerability profile of the three doses.
The CAP study will enroll approximately 160 patients in 40 study centers across the U.S., Canada, and Russia, and the Company expects to have preliminary data available when approximately 80 patients (50% of the planned patients) have completed the study. The Company intends to release data from all patients during the first half of 2008.
uSSSI Study Design
The uSSSI study is a Phase 2, multicenter, randomized, open-label, comparative study to evaluate the safety and efficacy of RX-1741 versus linezolid in the outpatient treatment of adult patients with uncomplicated Skin and Skin Structure Infections (uSSSI). The study will assess the efficacy of a single dose of RX-1741 given either once daily or twice daily compared to linezolid given twice daily for five to ten days in the treatment of ambulatory patients with uSSSI. It will also evaluate the safety and tolerability profile of these two doses compared to linezolid.
The uSSSI study will enroll approximately 150 patients in 25 study centers across the U.S. and the Company expects an interim analysis of the data to be performed when approximately 75 patients (50% of the planned patients) have completed the study. The Company intends to release data from all patients during the first half of 2008.
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
The Yates Network 617.460.3579 gina@theyatesnetwork.com |