April 10, 2017
XBiotech issued results of a double-blind, placebo-controlled, phase I-II study evaluating the safety and efficacy of 514G3 for the treatment of Staphylococcus aureus bloodstream infections. In the study, hospitalized adult patients with confirmed blood infections were randomized 3:1 (514G3 vs placebo) during a dose escalation phase to establish a phase II dose. The phase II portion was randomized 2:1 at the established phase II dose of 40mg/kg. A total of 52 patients were enrolled; 36 received 514G3 and 16 received placebo. Thirty of the 36 patients that were given 514G3 received the established phase II dose (40mg/kg). No drug-related adverse events were observed at any of the dose escalation levels and the 40mg/kg phase II dose was established without any dose-limiting toxicities (DLTs). A total of 28 SAEs in 15 patients were reported during the study period, including four deaths. There was a 49% relative risk reduction for the overall incidence of SAEs in subjects receiving 514G3 compared to those receiving placebo [(eight of 36 (22%) vs. seven of 16 (44%), respectively, (p=0.11)].
April 30, 2012
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.
April 10, 2006
Inhibitex has reported negative top-line results of a phase III trial of Veronate, their investigational antibody-based therapy for the prevention of hospitalization associated with Staphylococcus aureus infections. This multi-center, placebo controlled, double-blind study enrolled 2017 infants across 95 neonatal intensive care units in the US and Canada; subjects received up to four intravenous infusions of either 750 mg/kg Veronate or placebo, with follow-up through 70 days or hospital discharge. Trial data failed to demonstrate significance or a positive trend in the primary endpoint, the prevention of hospital-associated bloodstream infections due to S. aureus. Secondary endpoints were also negative, with no significant or positive-trended efficacy in the frequency of bloodstream infections caused by Candida, coagulase-negative staphylococci, and reduction in all-cause mortality.
February 13, 2006
Nabi Biopharmaceuticals has reported positive results of a phase I trial of their S. aureus Type 336 vaccine, for the prevention of Staphylococcus aureus infections. The vaccine was seen to be safe and well tolerated, and dose-related increases in anti-S. aureus Type 336 antibodies were noted. This double-blind, placebo-controlled study enrolled 48 healthy volunteers, who were randomized to receive 1 of 4 doses of the vaccine or placebo (9 vaccine:3 placebo per dose group). Based on these results, the company announced plans to initiate a phase II proof of concept study in the near future.
November 7, 2005
Nabi Biopharmaceuticals announced negative results of a phase III trial of StaphVAX, their investigational vaccine for the treatment and prevention of Staphylococcus aureus infections. Trial data failed to meet their primary efficacy endpoint, with no significant difference in rates of S. aureus types 5 and 8 infections, compared to placebo. Significant immunogenicity was noted, and additional data analysis was ongoing. This randomized, double-blinded, placebo-controlled study enrolled 3600 hemodialysis patients. Based on these results, Nabi terminated development of both StaphVAX and Altastaph, a related investigational compound based on the same mechanism of action.
May 16, 2005
Inhibitex has issued positive results of a phase II trial of Aurexis for the treatment of Staphylococcus aureus bloodstream infections. The drug produced favorable results in the primary composite endpoint of mortality, relapse rate and infection-related complications, with one death and one relapse of infection in the Aurexis-plus-antibiotics group, vs. four deaths in the antibiotics-alone group. Pharmacokinetic data indicated that peak plasma concentrations did not reach levels previously attained in phase I healthy volunteer studies. The drug also demonstrated efficacy in several secondary endpoints, including reduction in incidence of sepsis severity progression, reduction in ICU time for during re-hospitalization, and reduced incidence of candida infection, vs. antibiotics alone. This randomized, placebo-controlled, double-blind study enrolled 60 patients with documented S. aureus bloodstream infections across 12 US sites. Subjects received Aurexis or placebo in combination with a standard course of antibiotics, and were followed for 56 days. The company announced plans to initiate a follow-up phase II study of the drug, based on these results.
Vertex Pharmaceuticals issued interim results of a phase Ib trial of VX-950, their investigational protease inhibitor for the treatment of hepatitis C virus (HCV) infections. Data from the ongoing study indicated that the drug yielded significant antiviral activity, with subjects experiencing a median reduction in genome 1 HCV RNA of greater than 3 log10 within three days of treatment; subjects receiving 750 mg thrice daily achieving an additional median reduction greater than 4 log10 over days 3-14. This double-blind, randomized, placebo-controlled study enrolled 34 HCV patients across 3 European sites, and was designed to investigate the tolerability, pharmacokinetics, effect on viral kinetics, and optimum dosing regimen of the drug. Subjects received one of 3 oral doses of VX-950 (450 mg or 750 mg every 8 hours, or 1250 mg every 12 hours) or placebo for 14 days. The company announced plans to release more detailed results at the Digestive Disease Week conference on May 17.
November 22, 2004
Nabi Biopharmaceuticals reported mixed results of a phase II trial of Altastaph (Staphylococcus aureus Human Immune Globulin), for the prevention of Staphylococcus aureus infections in at-risk premature neonates. The trial met its primary safety, tolerability and pharmacokinetic endpoints, with no serious adverse events, and antibody levels believed to be protective against infections. However, the observed rate of Staphylococcal infection (3%) was considerably less than literature established baseline (5%-7%), and was not significantly different between placebo and Altastaph groups; these results thus failed to meet the secondary efficacy endpoint of a reduction in incidence of infections in neonates receiving Altastaph versus placebo. This double-blinded, placebo-controlled trial enrolled 200 very low birth-weight premature infants across 20 neonatal ICUs in the US. Subjects received one of two doses of Altastaph or placebo 14 days apart 3 to 7 days after birth. Following these results, Nabi announced plans to meet with regulators to discuss the timing and design of additional clinical studies.