Placebo

TLC Announces First Patient Enrollment in EXCELLENCE Trial Evaluating Single and Repeat Administrations of TLC599

Retrieved on: 
Wednesday, November 27, 2019
Health, Medicine, Clinical research, Organofluorides, Design of experiments, Clinical trial, Pharmaceutical industry, Dexamethasone, Placebo, Brilacidin

TLC599 is a non-opioid, proprietary BioSeizer sustained release formulation of dexamethasone sodium phosphate (DSP) intended to manage OA pain for up to six months.

Key Points: 
  • TLC599 is a non-opioid, proprietary BioSeizer sustained release formulation of dexamethasone sodium phosphate (DSP) intended to manage OA pain for up to six months.
  • The trial will take place across 40-50 sites in the US and Australia.
  • Patient enrollment is expected take about one year; all patients will be followed for a total of 52 weeks.
  • EXCELLENCE, a multi-center, randomized, double-blind, placebo- and active comparator-controlled pivotal Phase III clinical trial to evaluate the efficacy and safety of both single and repeated doses of TLC599, is currently underway.

Poxel Announces Positive Topline Results for Imeglimin Phase 3 Trial (TIMES 3 36-week) for the Treatment of Type 2 Diabetes in Japan

Retrieved on: 
Tuesday, November 26, 2019
Health, FDA, Diabetes, Clinical trials, Pharmaceutical, Biotechnology, Clinical research, Medicine, Health, Deception, Placebo, Articles, Palifermin, Riociguat

Overall, the safety and tolerability profile of Imeglimin was observed to be favorable for the entire portion of the 52-week trial.

Key Points: 
  • Overall, the safety and tolerability profile of Imeglimin was observed to be favorable for the entire portion of the 52-week trial.
  • In the first 16-week double-blind placebo-controlled treatment period, the incidence of treatment emergent adverse events was similar to the placebo group.
  • In the 36-week extension period, the safety and tolerability profile was consistent with the first part of the trial.
  • Poxel anticipates presenting full data results from the Phase 3 TIMES 3 trial at an upcoming scientific meeting.

MYOS RENS' Fortetropin® Clinical Trial Results to be Presented by William J. Evans, Ph.D., at the International Conference on Frailty and Sarcopenia Research

Retrieved on: 
Wednesday, November 20, 2019
Health, Medicine, Medical specialties, Clinical research, Rehabilitation medicine, Geriatrics, Aging-associated diseases, Sarcopenia, Senescence, Placebo, Clinical trial

For subjects who received Fortetropin, the average muscle protein synthesis rate was significantly higher compared to the placebo group.

Key Points: 
  • For subjects who received Fortetropin, the average muscle protein synthesis rate was significantly higher compared to the placebo group.
  • The ICFSR is the most important medical conference in the world focused on highlighting advances in sarcopenia research.
  • We feel truly honored that research highlighting the clinical impact of Fortetropin will be presented for the first time at this meeting.
  • The results from this clinical study will form the cornerstone of MYOS' 'Healthy Aging' Business," commented Joseph Mannello, Chief Executive Officer of Myos.

XBiotech Announces Rapid Enrollment for its Randomized Multi-Center Clinical Study for Bermekimab in Patients with Hidradenitis Suppurativa

Retrieved on: 
Tuesday, November 19, 2019
Health, Clinical research, Medicine, Medical research, Design of experiments, Hidradenitis suppurativa, RTT, Clinical trial, Placebo-controlled study, Placebo

AUSTIN, Texas, Nov. 19, 2019 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) today announces rapid enrollment in its randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating bermekimab in patients with moderate to severe Hidradenitis Suppurativa (HS).

Key Points: 
  • AUSTIN, Texas, Nov. 19, 2019 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) today announces rapid enrollment in its randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating bermekimab in patients with moderate to severe Hidradenitis Suppurativa (HS).
  • Today, XBiotech is already updating status of the study, reporting that 51 patients have now been randomized, or assigned to an investigational arm of the study.
  • Ms. Ashley Otero, XBiotechs Director of Clinical Operations, stated, We are extremely excited about the robust enrollment seen to date.
  • After only a few weeks since enrollment of the first patient, we have already randomized over one-third of the intended study population.

New Results From COSMIC-HF Presented at AHA 2019 Show Treatment of Heart Failure Patients With Omecamtiv Mecarbil Was Associated With Neutral or Improved Measures of Diastolic Function

Retrieved on: 
Monday, November 18, 2019
Health, Clinical research, Medicine, Pharmaceutical industry, Heart diseases, Adverse event, Placebo, Heart failure, Clinical trial, Draft:Q-SYMBIO, Ivabradine

Specifically, in patients receiving omecamtiv mecarbil E-wave velocity, E/A-ratio, and E/e or e were not significantly changed compared to placebo.

Key Points: 
  • Specifically, in patients receiving omecamtiv mecarbil E-wave velocity, E/A-ratio, and E/e or e were not significantly changed compared to placebo.
  • It is designed to evaluate whether treatment with omecamtiv mecarbil, when added to standard of care, reduces the risk of heart failure events (heart failure hospitalization and other urgent treatment for heart failure) and CV death in patients with HFrEF.
  • Adverse events (AEs), including serious AEs, in patients on omecamtiv mecarbil were comparable to placebo.
  • Omecamtiv mecarbil is the subject of an international clinical trials program in patients with heart failure including GALACTIC-HF and METEORIC-HF.

Karuna Therapeutics Announces KarXT Met Primary Endpoint in Phase 2 Clinical Trial of Acute Psychosis in Patients with Schizophrenia

Retrieved on: 
Monday, November 18, 2019
Biotechnology, Mental health, Health, Pharmaceutical, Clinical trials, Clinical research, Deception, Placebo, Medicine, Health, Schizophrenia, Clinical medicine, RTT, LY-404,039, Sertraline, the Trial, Schizophrenia, Karuna

KarXT was well tolerated in the Phase 2 trial, with similar discontinuation rates between KarXT (20%) and placebo (21%).

Key Points: 
  • KarXT was well tolerated in the Phase 2 trial, with similar discontinuation rates between KarXT (20%) and placebo (21%).
  • In the clinical trial, patients demonstrated a clinically meaningful and statistically significant 11.6 point mean reduction over placebo in total PANSS score, the trials primary efficacy endpoint.
  • Overall, KarXT was well tolerated in the clinical trial, with similar discontinuation rates of patients on KarXT, 20%, and placebo, 21%.
  • Karuna will hold a webcast and conference call this morning at 8:30 a.m. EST to provide results from its Phase 2 clinical trial of KarXT for the treatment of acute psychosis in patients with schizophrenia.

Bempedoic Acid Lowers LDL-Cholesterol without Adversely Impacting Glycaemic Control in Pooled Analyses of Phase 3 Trials Presented at the American Heart Association 2019 Scientific Sessions

Retrieved on: 
Monday, November 18, 2019
Science, Cardiology, Biotechnology, Research, Pharmaceutical, Health, Diabetes, Clinical trials, Health, Clinical research, Medicine, Hepatotoxins, Statin, Daiichi Sankyo, Clinical trial, Placebo

Daiichi Sankyo Europe GmbH (hereafter, Daiichi Sankyo) today announced the results of two pooled analyses from four Phase 3 clinical trials of bempedoic acid which were presented at the American Heart Association (AHA) Scientific Sessions in Philadelphia.

Key Points: 
  • Daiichi Sankyo Europe GmbH (hereafter, Daiichi Sankyo) today announced the results of two pooled analyses from four Phase 3 clinical trials of bempedoic acid which were presented at the American Heart Association (AHA) Scientific Sessions in Philadelphia.
  • Bempedoic acid and glycemic control: A pooled analysis of 4 phase 3 clinical trials.
  • Efficacy of bempedoic acid: A pooled analysis of 4 pivotal phase 3 clinical trials.
  • Efficacy and safety of bempedoic acid added to ezetimibe in statin-intolerant patients with hypercholesterolemia: A randomized, placebo-controlled study.

Esperion Announces Pooled Analyses from Phase 3 LDL-C Lowering Clinical Development Program of Bempedoic Acid Presented at the American Heart Association 2019 Scientific Sessions

Retrieved on: 
Sunday, November 17, 2019
Medicine, Clinical medicine, Health, Diabetes, Clinical research, Blood tests, Glucose, Glycated hemoglobin, Hemoglobins, Esperion Therapeutics, Bempedoic acid, Placebo

ANN ARBOR, Mich., Nov. 17, 2019 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that pooled analyses from four Phase 3 clinical studies of bempedoic acid were presented at the American Heart Association (AHA) Scientific Sessions in Philadelphia.

Key Points: 
  • ANN ARBOR, Mich., Nov. 17, 2019 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that pooled analyses from four Phase 3 clinical studies of bempedoic acid were presented at the American Heart Association (AHA) Scientific Sessions in Philadelphia.
  • The presentation highlighted that bempedoic acid reduced hemoglobin A1c (HbA1c) by 0.19% versus placebo in patients with diabetes (n=1,134) at 12 weeks.
  • The analysis also showed that patients on bempedoic acid had fewer instances of new-onset diabetes as well as hyperglycemia than those on placebo.
  • In addition, a poster, titled Efficacy of Bempedoic Acid: A Pooled Analysis of 4 Pivotal Phase 3 Clinical Trials was presented by Maciej Banach, MD, PhD, FAHA, FESC.

resTORbio Announces That the Phase 3 PROTECTOR 1 Trial of RTB101 in Clinically Symptomatic Respiratory Illness Did Not Meet the Primary Endpoint

Retrieved on: 
Friday, November 15, 2019
Respiratory diseases, Health, Medicine, Epidemiology, Infection, RTI, Respiratory tract infection, Respiratory disease, Placebo, Respiratory tract

The primary endpoint of the trial was the reduction in the percentage of subjects with clinically symptomatic respiratory illness, defined as illness associated with a respiratory tract infection, or RTI, based on prespecified diagnostic criteria, with or without laboratory confirmation of a pathogen.

Key Points: 
  • The primary endpoint of the trial was the reduction in the percentage of subjects with clinically symptomatic respiratory illness, defined as illness associated with a respiratory tract infection, or RTI, based on prespecified diagnostic criteria, with or without laboratory confirmation of a pathogen.
  • The PROTECTOR 1 trial included 1024 patients who were randomized 1:1 to receive RTB101 or placebo administered once daily for 16 weeks.
  • resTORbio, Inc. is a clinical-stage biopharmaceutical company developing innovative medicines that target the biology of aging to prevent or treat aging-related diseases.
  • No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

American BriVision Announces Issuance of a Full Clinical Study Report (CSR) for ABV-1504 for Major Depressive Disorder Phase II Study

Retrieved on: 
Thursday, November 14, 2019
Clinical research, Clinical psychology, Medicine, Hamilton Rating Scale for Depression, Health, Placebo, Hamilton Anxiety Rating Scale

In the per protocol population, the high-dose cohort had a 13.4-point reduction in MADRS as compared to an 8.6-point reduction in the placebo group.

Key Points: 
  • In the per protocol population, the high-dose cohort had a 13.4-point reduction in MADRS as compared to an 8.6-point reduction in the placebo group.
  • A significant group difference in net change in HAM-D-17 and HAM-A (Hamilton Anxiety Rating Scale) at week 2 was also found.
  • Post-hoc, pair-wise comparisons demonstrated a significant difference between high-dose group and placebo group in HAM-D-17 (High dose -7.90 vs.
  • The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.