Merck Announces New Data from HIV/HCV Co-Infected Patients in the Ongoing C-WORTHY Study
Mar 5 14
Merck announced new data from HIV/HCV co-infected patients in the ongoing C-WORTHY Study, a Phase 2 clinical trial evaluating the efficacy and safety of Merck's all-oral, once-daily regimen combining MK-5172, an investigational hepatitis C virus (HCV) NS3/4A protease inhibitor, and MK-8742, an investigational HCV NS5A replication complex inhibitor. In these co-infected patients, the administration of MK-5172/MK-8742 for 12 weeks resulted in robust HCV suppression, and a safety profile consistent with that observed for patients infected with HCV Genotype 1 infection (GT1) alone. At 12 weeks, 100% (29/29) of co-infected patients who received MK-5172/MK-8742 and ribavirin (RBV), and 90% (26/29) of co-infected patients who received MK-5172/MK-8742 alone had HCV RNA levels of less than 25 IU/mL, versus 100% (13/13) in patients with HCV alone treated with MK-5172/8742. The data were presented at the 21(st) Conference on Retroviruses and Opportunistic Infections (CROI). After 4 weeks of treatment, all co-infected patients showed a reduction in HCV RNA levels to below 25 IU/mL with or without RBV administration. HCV kinetics over the first 4 weeks of therapy were similar in patients with or without HIV co-infection. There were three treatment failures in the HIV/HCV co-infected study arms; one subject completed the treatment regimen but was lost to follow-up (HCV RNA undetectable at the last visit on record); and two co-infected subjects with low pharmacokinetic levels of MK-5172 and/or MK-8742 experienced virologic breakthrough at the 8 week time point (both cases with low blood levels of MK-5172 and/or MK-8742). In the HIV/HCV co-infection arms, 59 treatment-naïve, non-cirrhotic, GT1 HIV/HCV co-infected patients on a stable antiretroviral regimen (raltegravir + tenofovir or abacavir with either 3TC or FTC) were examined. These subjects were randomized at a 1:1 ratio to receive 12 weeks of MK-5172 (100 mg QD) administered concomitantly with MK-8742 (50 mg QD), with or without twice daily (BID) RBV.
Merck Announces Results from Phase 2b Study of Mk-8237
Mar 4 14
Merck announced results from a Phase 2b study evaluating two doses of its investigational house dust mite sublingual immunotherapy tablet (MK-8237). The data were presented for the first time during a oral session at the 2014 Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in San Diego. The study was conducted in 124 adult patients 18 years of age and older with house dust mite-induced allergic rhinitis, with or without conjunctivitis, using an environmental exposure chamber. In the study, MK-8237 at once-daily doses of 6 Development Units (DU) and 12 DU produced a significant dose- and time-dependent reduction in average total nasal symptom score (TNSS) over the last four hours of the chamber challenge at week 24 of treatment compared to placebo (-27%=6 DU, -49%=12 DU; p<0.05 for both vs. placebo), the primary efficacy endpoint of the study. TNSS is the total score for four nasal symptoms: itchy nose, blocked nose, runny nose and sneezing. In this double-blind, single-site, Phase 2b study, 124 adults, 18 years of age or older, with house dust mite-induced allergic rhinitis, with or without conjunctivitis, were randomized to receive 6 DU (n=41) or 12 DU (n=42) of MK-8237 sublingual tablets once daily for 24 weeks or placebo (n=41). Sensitivity to house dust mite allergen was determined by specific IgE testing. Patients with unstable uncontrolled/partially controlled or severe asthma were excluded from the study, as were patients with forced expiratory volume in 1 second (FEV(1)) <70% of predicted value. Participants were exposed to the house dust mite allergen using an environmental exposure chamber at weeks 8, 16 and 24. This method allows for controlled and reproducible conditions that provide a constant concentration of allergen over a six-hour period with patients recording symptoms every 15 minutes. Both doses of MK-8237 showed a significant dose- and time-dependent reduction in average TNSS over the last four hours of the chamber challenge at week 24 of treatment compared to placebo (-27%=6 DU, -49%=12 DU; p<0.05 for both vs. placebo). Key secondary efficacy endpoints of the study were average TNSS over the last four hours of the chamber challenge at weeks 8 and 16 compared to placebo, and average total symptom score (TSS) over the last four hours of the chamber challenge at week 24 compared to placebo. TSS is the total score for four nasal symptoms (itchy nose, blocked nose, runny nose and sneezing) and two ocular symptoms (gritty feeling/red/itchy eyes and watery eyes). MK-8237 demonstrated dose-dependent reductions versus placebo in average TNSS at week 8 (-8%=6 DU; p=NS and -20%=12 DU; p<0.05) and at week 16 (-18%=6 DU, -30%=12 DU; p<0.05 for both vs. placebo). MK-8237 also demonstrated dose-dependent reductions versus placebo in average TSS at week 24 (-29%=6 DU, -52%=12 DU (p<0.05 for both vs. placebo). In this study, the most common adverse events (incidence >= 5%) occurring in patients receiving MK-8237 6 DU, 12 DU or placebo, respectively, were throat irritation (34%, 52%, 0%), mouth edema (24%, 24%, 0%), lip swelling (5%, 17%, 2%), oral pruritus (15%, 14%, 0%), dyspepsia (2%, 10%, 0%), ear pruritus (0%, 7%, 0%), swollen tongue (0%, 5%, 0%), oropharyngeal swelling (0%, 5%, 0%) and pharyngeal edema (2%, 5%, 0%). There were no local swellings of severe intensity and no serious adverse events reported in patients treated with MK-8237. The majority of adverse events in this study were assessed as mild or moderate. There were no investigator reported systemic allergic reactions or reactions treated with epinephrine for either dose of MK-8237. A Phase 3 study of MK-8237 in adolescents and adults with house dust mite-induced allergic rhinitis is currently screening patients. Additional Merck Research Presented at AAAAI: Efficacy of the Short-Ragweed Sublingual Immunotherapy Tablet MK-3641 in Monosensitized and Polysensitized Subjects (Poster 756); The Effect of the Ragweed Sublingual Immunotherapy Tablet MK-3641 on Rescue Medication Use (Poster 972); The Efficacy and Safety of the Short-Ragweed Sublingual Immunotherapy Tablet MK-3641 is Similar in Asthmatic and Nonasthmatic Subjects Treated for Allergic Rhinitis with/without Conjunctivitis (AR/C) (Poster 754); Magnitude of Changes in Patient Symptom and Medication Scores in Grass Allergy Immunotherapy Trials: Dependency on Levels of Pollen Exposure (Poster 767).
Merck & Co. Inc. Announces Amendments to By-Laws
Feb 28 14
On February 25, 2014, the board of directors of merck & co., inc. amended article i, section 2 of the by-laws of the company to provide that special meetings of shareholders may be called by shareholders owning at 15% of the combined voting power of the then outstanding shares of all classes and series of capital stock of the company entitled generally to vote in the election of directors of the company. Previously, the required threshold amount for calling a special meeting of shareholders was 25%. The amendments also establish procedural guidelines and requirements for shareholders to request a special meeting. The amendments took effect immediately upon approval by the board.