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PolyMedix issued results from a phase II trial of PMX-30063 for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by Staphylococcus aureus. The randomized, double-blinded and controlled study enrolled 215 subjects with ABSSSI due to either methicillin susceptible (MSSA) or methicillin resistant (MRSA) S. aureus. The subjects received one of three dosing regimens of PMX-30063 or daptomycin active control. PMX-30063 was administered at 0.4 mg/kg on day one followed by 0.30 mg/kg daily for four days; 0.75 mg/kg on day one followed by 0.35 mg/kg daily for four days; or 1.0 mg/kg on day one followed by 0.35 mg/kg daily for four days plus two days of placebo for a total of seven days. Daptomycin was administered daily for seven days. Clinical and microbiologic response was assessed at 72 hours (Day 3). All three doses of PMX-30063 resulted in high clinical response rates at 72 hours. In the per protocol population the clinical response rates were 85.0%, 71.4%, 89.7% and 74.5% in the PMX-30063 low, medium and high dose arms and the daptomycin arm, respectively. The most commonly reported adverse events reported in the PMX-30063 treatment arms were numbness and tingling.
Foamix released results from a phase II trial of Minocycline foam for the treatment of impetigo. This randomized, double blind, dose-ranging study enrolled 32 subjects, ages 2 to 15, with impetigo. The subjects received Minocycline foam 1% or 4% twice daily for seven days. They were checked for response on day 14. Clinical response at the end of the treatment was 92% and 100% respectively for the low or high doses; and all subjects (100%) showed success on day 14. In addition, 80% of the total population were cured or improved significantly after three days of treatment. Eight subjects had MRSA and in all of them the bacterial infection was eradicated on day seven. No drug related side effects were reported.
Rib-X reported results from a phase IIb trial of delafloxacin for acute bacterial skin and skin structure infections. This randomized, active controlled, double blind trial enrolled 256 adults who received delafloxacin alone (300 mg intravenously every 12 hours), or Zyvox (linezolid) or vancomycin at the recommended doses, both with and without aztreonam. The trial met the primary endpoint, the Investigators Global Assessment of Cure. Clinical cure was reached by 70.4%, 64.9% and 54.1% of subjects in the delafloxacin, Zyvox plus/minus aztreonam and vancomycin plus/minus aztreonam arms, respectively, with statistical superiority in comparison to vancomycin (p≡0.031). In a group of subjects with confirmed MRSA, the clinical cure was reached by 59.3%, 51.5% and 56.3% of subjects in the three arms, respectively. Overall adverse event rates were statistically equivalent across the study arms.
Polymedix reported interim results from a phase II trial of PMX-30063 for the treatment of acute bacterial skin and skin structure infections (ABSSI). Data are from 80 subjects with ABSSSI due to either methicillin-susceptible or methicillin-resistant S. aureus. The subjects were randomized to receive either one of three five-day dose regimens of PMX-30063 or the standard of care, daptomycin, for the approved seven-day dose regimen. The combined data for all treatment arms showed a clinical cure rate of 92%, with each of the four dosing arms having clinical cure rates ranging from 87% to 100%. All dose groups were safe and generally well-tolerated.
Nabriva Therapeutics issued results from a phase II trial of BC-3781 for acute bacterial skin and skin structure infections. This double blind trial enrolled 210 subjects and was designed to compare BC-3781 to Vancomycin, the standard of care. The subjects received 100mg or 150mg of BC-3781 or 1,000mg Vancomycin intravenously twice-daily. Both doses of BC-3781 were comparable to Vancomycin in terms of clinical response: 90% and 89% of subjects treated with 100mg and150mg of BC-3781, respectively, and 92% of the subjects treated with Vancomycin. In addition, the early clinical response was assessed using a composite endpoint (cessation of spread of erythema with a lack of fever) at day three. This endpoint was reached by 83% and 86% of subjects in the 150 mg and 100mg BC-3781 arms, respectively and 80% of subjects in the Vancomycin arm. BC-3781 was well tolerated.
NovaBay reported positive results from a phase IIa trial of NVC-422 for the topical treatment of impetigo due to Staphylococci. This double blind, randomized, sequential group study enrolled 129 pediatric subjects, ages two to 12, in the Dominican Republic. The subjects were treated with low, medium or high doses of NVC-422 gel three times a day for seven days. Clinical response and bacteriological efficacy were evaluated after one week of treatment and during a follow-up visit one week later. Response was evaluated using the Skin Infection Rating Scale. Clinical response rates at the end of the treatment were 85%, 87% and 92% respectively for the low, medium or high doses. Bacteriological response rates at the end of the treatment were 87%, 89% and 95%, respectively. The response rate for 10 patients infected with methicillin-resistant Staphylococcus aureus who completed treatment was 100%. The treatment was well-tolerated.
Trius reported positive results from a phase II trial of oral torezolid for the treatment of severe complicated skin and skin structure infections (cSSSI). This randomized, double-blind, dose-ranging study enrolled 188 subjects with cSSSI caused by gram-positive bacteria. Torezolid was administered orally at doses of 200, 300 or 400 mg once-daily for five to seven days. Of the 188 enrolled subjects, 164 were clinically evaluable at the test-of-cure visit. The overall cure rates for severe abscesses, cellulitis and wound infections were 96%, 97% and 90%, respectively. Clinical cure rates by dose in the evaluable population were 98%, 94% and 94% for the 200, 300 and 400 mg doses, respectively. In the group of microbiologically evaluable subjects, clinical cure was achieved in 100%, 93% and 96% of the 200, 300 or 400 mg dose groups, respectively. Torezolid was well tolerated.
Forest Labs released positive results from two phase III trials of ceftaroline for the treatment of complicated skin and skin structure infections (cSSSI). These international, randomized, double-blind comparative studies, dubbed CANVAS I and CANVAS II, enrolled 1,396 adult subjects with cSSSI caused by gram-positive and gram-negative bacteria. The primary endpoint was non-inferiority of ceftaroline compared to vancomycin plus aztreonam, with a non-inferiority margin of 10%. This endpoint was reached; the ceftaroline arm had a clinical cure rate of 91.6% compared to a 92.7% clinical cure rate in the vancomycin plus aztreonam arm. In addition, ceftaroline had a microbiological eradication rate of 92.4% compared to a vancomycin plus aztreonam rate of 93.6% for all pathogens. The ceftaroline clinical cure rate was 93.1% in Staphylococcus aureus infections in the microbiologically evaluable population and 93.3% for MRSA infections. Treatment was well tolerated, with an adverse events profile similar between the two treatment arms. Based on the results Forest plans to continue with the development of ceftaroline.
Arpida reported positive results from a phase III trial, dubbed ASSIST-2 (Arpida Skin and Skin Structure Infection STudies), of iclaprim for the treatment of complicated skin and skin structure infections (cSSSI). This randomized, blinded, comparator controlled trial enrolled 494 subjects internationally. The trial was designed to compare intravenous iclaprim to linezolid (standard of care). The primary efficacy endpoint, statistical non-inferiority in the clinical cure rate at the Test-Of-Cure (TOC) visit, was achieved. The overall clinical cure rates were 84.9% and 87.2% for iclaprim and linezolid, respectively. The microbiological eradication rates for methicillin-susceptible S. aureus (MSSA) bacteremia were 83.5% and 84.7% for iclaprim and linezolid respectively and for methicillin-resistant strains (MRSA) 77.0% and 80.0%, respectively. The incidence of drug-related adverse events was higher in the linezolid arm compared to the iclaprim arm (34.6% versus 27.9%, respectively). Based on positive phase III results, Arpida plans to file a NDA with the FDA later in 2007.
Anadys Pharmaceuticals has reported positive results of a phase I b trial of isatoribine, a Toll-like receptor 7 agonist for the treatment of chronic hepatitis C (HCV) infections. Trial data indicated that the drug was biologically active, with significant changes in interferon-alpha-mediated disease markers, and produced a significant 82% reduction in serum viral load after seven days at the highest dosing regimen. Treatment was also observed to be safe and well tolerated, with no discontinuations or regimen changes due to adverse events. This dose escalating, open-label study enrolled a total of 32 adult HCV patients across 2 European centers into one of four seven-day dosing regimens (200 mg, 400 mg, 600 mg or 800 mg daily). Anadys announced that the trial would serve as the basis for upcoming trials of their investigational isatoribine pro-drug ANA975.
Inhibitex reported positive results of a phase I trial of their investigational anti-microbial monoclonal antibody Aurexis, for the adjuvant treatment of serious Staphylococcus aureus (S. aureus) infections, at the 44th annual Interscience Conference on Antimicrobial Agents and Chemotherapy. Trial results showed Aurexis was generally safe and well-tolerated by the study participants, and had an elimination half life of Aurexis was approximately 21 days. This open-label, dose-escalating trial enrolled 19 healthy patients who receive one of four dose levels of Aurexis. The company announced that they expected to use these findings to support ongoing enrollment efforts in their phase II trial of the drug plus standard antibiotic therapy in patients with hematological S. aureus infections.
Microscience issued positive results of a phase I trial of their oral hepatitis B (HBV) vaccine spi-VECTM. Study data met their primary safety endpoint, with no significant adverse events noted. Further, the drug was shown to be significantly immunogenic, with all subjects generating a T-cell response to hepatitis B core antigen (HBcAg), and 95% subjects in the high-dose group exhibited an immune response marked by the gamma interferon secretion and IL-5 down-regulation in stimulated T-cells. This type of immune response is known to promote viral clearance in chronic HBV infections. This open-label dose-escalating study enrolled 30 healthy volunteers, who received two single escalating oral doses of the vaccine 56 days apart. Microscience announced that they were planning phase II trials for spi-VECTM, based upon these results.
Theravance has reported results from a phase II study of their investigational antibiotic telavancin (TD-6424), for the treatment of Gram-positive skin and skin structure infections (cSSSI). Results indicated that the drug demonstrated comparable efficacy and improved dosing options than standard therapy. Specifically, the drug produced statistically non-distinct cure rates in patients with cSSSIs, including an 82% cure rate among the subset of patients with cSSSIs caused by methycillin-resistant S. aureus infections (vs. 69% for standard therapy with vancomycin), and the minimum inhibitory concentration were lower for telavancin than vancomycin for all S. aureus strains. This exploratory standard-therapy-controlled safety and efficacy trial enrolled a total of 167 subjects with cSSSIs. These data will be used to support ongoing phase III studies of the drug.<
InterMune reported positive results from a phase III trial investigating oritavancin, an antibiotic for the treatment of complicated skin/skin structure infections (cSSSI). Results demonstrated that oritavancin was as effective as the comparator regimen of vancomycin followed by cephalexin, even when administered for approximately half the number of days. In addition, oritavancin was significantly better tolerated than the comparator regimen. The primary efficacy endpoint of clinical cure of infection and the secondary measure of bacteriological eradication were achieved. The double blind, active comparator, non-inferiority study enrolled 1,267 subjects with cSSSI caused by gram-positive pathogens at 103 sites in 22 countries. It was designed to assess the clinical and bacteriological efficacy of intravenous therapy with oritavancin alone versus with vancomycin followed by oral therapy with cephalexin.
Vicuron reported positive results from a phase II trial investigating dalbavancin, a glycopeptide antibiotic for the treatment of skin and soft tissue infections (SSTIs). Results showed higher clinical and microbiological response rates compared to a variety of standard care regimens. Data demonstrated higher clinical (94.1%) and microbiological (72.7%) response rates for deep SSTIs with two doses versus a single dose of dalbavancin (61.5% clinical; 27.3% microbiological) or control (76.2% clinical; 64.3% microbiological). The control arm consisted of investigator-specified standard of care such as treatment with one of the antibiotics, clindamycin, ceftriaxone, vancomycin or cefazolin. The randomized, controlled study enrolled 62 subjects with complicated SSTIs. Dalbavancin was well tolerated and adverse events were infrequent. Results were presented at the European Congress of Clinical Microbiology and Infectious Diseases.