Active substances: Ciprofloxacin
Solithromycin could be used in monotherapy to treat CABP and also gonorrhea, chlamydia and mycoplasma infections. We believe solithromycin, with its unique chemical structure, retains and improves on the beneficial features of macrolides and can overcome the shortcomings of existing therapies.
These trials are randomized, double-blinded studies using a respiratory fluoroquinolone, moxifloxacin Avelox, for which we had to show non-inferiority for efficacy and acceptable safety and tolerability. Being a global study, the same dose was required to be used in our Phase 3 trials.
Non-inferiority for efficacy means solithromycin will have to prove it is statistically as effective as a comparator drug within a pre-defined margin.
Solithromycin also met the secondary objectives of non-inferiority in clinical success at the short term follow up, or SFU, visit, 5-10 days after the end of therapy, both in the ITT and clinically evaluable populations.
The point estimates for the primary endpoint of early clinical response were 78.Our lead product, solithromycin CEM-101, is being developed in oral capsules, intravenous, or IV, and suspension formulations, for community settings to meet critical medical or CABP, one of the most infectious diseases, particularly respiratory tract infections in adults and children, as well and other indications. Business Summary We are a clinical-stage pharmaceutical company focused on developing differentiated antibiotics for the acute care and the treatment of community-acquired bacterial pneumonia, needs in the treatment of bacterial serious infections of the respiratory tract and staphylococcal infections as for the treatment of gonorrhea.
The results were similar in the combined total patient population, however, initial sub-groups analysis by age, indicate that the difference in efficacy point estimates became larger with increases in patient age and favored solithromycin in the ITT early clinical response groups.
The results for the secondary efficacy endpoints supported results from the primary endpoint.
The U. And each day, in places like Zimbabwe, despots enact cruelty on their people. She escaped in hercar unhurt.
Fellow 7-year-old Alana Thompson, aka Honey Boo Boo, has her flaws, but she has learned to embrace the spotlight. Currently, outpatient CABP is treated with a macrolide, such as azithromycin, or with a fluoroquinolone, such as levofloxacin. In the last decade, azithromycin treatment failure due to resistance has led to more frequent use of fluoroquinolones, which are known to have recognized serious side effects.
Yet, because of the need to treat outpatients, levofloxacin a fluoroquinolone use has increased. There has not been a new oral antibiotic to treat CABP in outpatients since moxifloxacin was approved, and resistance and lack of tolerability to generic antibiotics, including macrolides, have led to increased rates of hospitalization and a critical need for a safe and effective oral antibiotic for the treatment of CABP.
Currently available intravenous antibiotics that are the standard of care, such as ceftriaxone, a third generation cephalosporin, have no oral formulations to allow discharge from the hospital on the same medication, forcing patients to switch to less favorable alternatives.
Cephalosporins and fluoroquinolones that are currently used have broad spectrum activity, and eliminate essential intestinal microflora with resulting serious consequences, such as C.
In order to practice stewardship of antibiotics, and provide the right care for CABP, we believe a new macrolide is needed. Solithromycin is a potent new fourth generation macrolide and the first fluoroketolide in clinical development.
As a macrolide, solithromycin has broad use potential against many types of infections and in many patient populations, including pediatrics and pregnancy.
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