Clinical endpoint

ACADIA Pharmaceuticals to Combine CLARITY-2 and CLARITY-3 Phase 3 Studies Evaluating Pimavanserin for the Adjunctive Treatment of Major Depressive Disorder

Retrieved on: 
Tuesday, May 26, 2020
Mental health, Health, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, RTT, Psychiatry, Abnormal psychology, Psychiatric diagnosis, Chemical compounds, 5-HT2A antagonists, Pimavanserin, Ureas, Dementia, Psychosis, Major depressive disorder, Clinical endpoint

The primary endpoint in both studies is the change from baseline on the 17-item Hamilton Depression Rating Scale (HAMD-17) total score.

Key Points: 
  • The primary endpoint in both studies is the change from baseline on the 17-item Hamilton Depression Rating Scale (HAMD-17) total score.
  • Patients who completed the Phase 3 studies were eligible to participate in the ongoing 52-week open-label extension study to evaluate the long-term safety and tolerability of pimavanserin in MDD.
  • On the key secondary endpoint, pimavanserin demonstrated statistically significant reductions compared to placebo in the Sheehan Disability Scale score (p=0.004).
  • ACADIA is evaluating pimavanserin in an extensive clinical development program across multiple indications with significant unmet need including dementia-related psychosis, adjunctive major depressive disorder, and the negative symptoms of schizophrenia.

Boehringer Ingelheim and Lilly to collaborate with Duke Clinical Research Institute on a pragmatic trial examining empagliflozin’s effects following an acute myocardial infarction

Retrieved on: 
Tuesday, May 26, 2020
Science, Cardiology, Research, Pharmaceutical, General Health, Health, Diabetes, Clinical trials, Health, RTT, Articles, Medicine, Boehringer Ingelheim, Anti-diabetic drugs, Empagliflozin, Ethers, Clinical endpoint, Eli Lilly and Company, Myocardial infarction, Acute

Boehringer Ingelheim and Eli Lilly and Company (NYSE:LLY) today announced an academic research collaboration with the Duke Clinical Research Institute (DCRI) on a new trial, EMPACT-MI (EMPAgliflozin for the prevention of Chronic heart failure and morTality after an acute Myocardial Infarction).

Key Points: 
  • Boehringer Ingelheim and Eli Lilly and Company (NYSE:LLY) today announced an academic research collaboration with the Duke Clinical Research Institute (DCRI) on a new trial, EMPACT-MI (EMPAgliflozin for the prevention of Chronic heart failure and morTality after an acute Myocardial Infarction).
  • This randomized clinical trial will be conducted, analyzed and reported in partnership with the DCRI, with Boehringer Ingelheim and Lilly providing funding.
  • View the full release here: https://www.businesswire.com/news/home/20200526005445/en/
    EMPACT-MI will include approximately 3,300 adults across at least 16 countries who have had an acute myocardial infarction.
  • The primary endpoint of the trial is to assess the effect of empagliflozin on all-cause mortality and hospitalization for heart failure.

Dupixent® (dupilumab) eosinophilic esophagitis trial meets both co-primary endpoints

Retrieved on: 
Friday, May 22, 2020
Clinical research, Health, Clinical trials, Medicine, Articles, Medical statistics, Design of experiments, Acute pain, Esophagitis, Clinical endpoint, Placebo

The trial met both of its co-primary endpoints, as well as all key secondary endpoints.

Key Points: 
  • The trial met both of its co-primary endpoints, as well as all key secondary endpoints.
  • Dupixent is the first and only biologic to show positive and clinically-meaningful results in this population as part of a Phase 3 trial.
  • The Phase 3, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent in adolescents and adults with eosinophilic esophagitis.
  • Part A of the trial enrolled 81 patients aged 12 years and older with eosinophilic esophagitis, as determined by histological and patient-reported measures.

Agios Announces Publication of TIBSOVO® Phase 3 Data in The Lancet Oncology Demonstrating Significant Improvement in Progression-Free Survival Compared to Placebo in Previously Treated IDH1-Mutant Cholangiocarcinoma Patients

Retrieved on: 
Tuesday, May 19, 2020
Health, Clinical research, Medical statistics, Medicine, Clinical trials, Articles, Hepatology, Design of experiments, Clinical endpoint, Progression-free survival, Cholangiocarcinoma, Blinded experiment

The study met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) in patients randomized to TIBSOVO compared with placebo patients.

Key Points: 
  • The study met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) in patients randomized to TIBSOVO compared with placebo patients.
  • Thirty-five patients randomized to placebo (57.4%) crossed over to open-label TIBSOVO upon radiographic disease progression and unblinding.
  • TIBSOVOis not approved in any country for the treatment of patients with previously treated advanced IDH1-mutant cholangiocarcinoma.
  • Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal if not treated.

Progenics to Present Results from the Phase 3 CONDOR Trial of PyL™ (18F-DCFPyL) in Prostate Cancer at the American Society of Clinical Oncology 2020 Virtual Scientific Program

Retrieved on: 
Monday, May 18, 2020
Branches of biology, Medicine, Health, Medical imaging, Medicinal radiochemistry, Medical physics, Radiation therapy, Glutamate carboxypeptidase II, Peptidase, Prostate cancer, Clinical endpoint, Tomography

PyL is the Companys PSMA-targeted small molecule positron emission tomography (PET) imaging agent designed to visualize prostate cancer.

Key Points: 
  • PyL is the Companys PSMA-targeted small molecule positron emission tomography (PET) imaging agent designed to visualize prostate cancer.
  • 63.9% of patients in the CONDOR trial had a change in intended disease management plans due to PyL imaging results, a key secondary endpoint of the trial.
  • Consistent with the Phase 2 OSPREY trial results, safety results showed that PyL was well tolerated.
  • The full positive results of our Phase 3 CONDOR trial continue to validate our beliefs in PyL to potentially alter the way physicians treat prostate cancer.

Top-line Results from a Phase 2b Study of PTI-125 in Alzheimer’s Disease Does Not Meet Primary Endpoint

Retrieved on: 
Friday, May 15, 2020
Food and drink, Articles, Health, Caribbean cuisine, Cassava, Jamaican cuisine, Manihoteae, Tubers, Clinical endpoint

AUSTIN, Texas, May 15, 2020 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA) today reported top-line results from a Phase 2b study of PTI-125, its lead investigational drug, in patients with Alzheimers disease.

Key Points: 
  • AUSTIN, Texas, May 15, 2020 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA) today reported top-line results from a Phase 2b study of PTI-125, its lead investigational drug, in patients with Alzheimers disease.
  • PTI-125 significantly reduced a secondary endpoint, CSF levels of IL1-beta (p
  • The drug effects of PTI-125, if any, may have been masked in this study by high variability in levels of biomarkers of disease.
  • Phase 2b was a double-blind, randomized, placebo-controlled study of PTI-125 in 64 patients with mild-to-moderate Alzheimers disease, 50-85 years of age, with MMSE 16 to 26.

Cellworks Singula™ Predicts Personalized Therapy Responses for Pancreatic Cancer Patients with 94% Accuracy

Health, Oncology, Survival rate, Pancreatic cancer, Clinical endpoint, Academic disciplines, Articles

This study demonstrates that Cellworks Singula can predict, with very high accuracy, whether an individual pancreatic cancer patient will respond to a treatment.

Key Points: 
  • This study demonstrates that Cellworks Singula can predict, with very high accuracy, whether an individual pancreatic cancer patient will respond to a treatment.
  • By providing oncologists with accurate predictions of therapy responses for individual patients prior to treatment, this tool has the potential to improve the median survival rates for pancreatic cancer patients.
  • Cellworks Singula therapy response predictions are generated through extensive biosimulation of a personalized patient disease model based on the patients multi-omics data.
  • The accuracy of Cellworks Singula therapy response predictions was compared to the accuracy of prescribed therapies and clinical outcomes.

Helsinn and MEI Pharma Announce Updated Clinical Data from the Phase 2 Study Evaluating Pracinostat in Combination with Azacitidine in Patients with High/Very-high Risk Myelodysplastic Syndromes

Retrieved on: 
Wednesday, May 13, 2020
Health, Lactams, Nucleosides, Triazines, Orphan drugs, Azacitidine, Myelodysplastic syndrome, Clinical endpoint, Chemical substances, Medicine, Vadastuximab talirine

The study results will be featured in a poster at the American Society of Clinical Oncology 2020 Virtual Scientific Program.

Key Points: 
  • The study results will be featured in a poster at the American Society of Clinical Oncology 2020 Virtual Scientific Program.
  • "These data are promising and I continue to be encouraged by my experience to date with the combination of pracinostat and azacitidine evaluated in this study.
  • The primary endpoints were safety and tolerability of pracinostat in combination with azacitidine and ORR, defined as CR plus partial response (PR).
  • It is also being evaluated in a Phase 2 study in patients with high or very high-risk myelodysplastic syndrome ("MDS").

U.S. FDA Clears Pluristem’s IND Application for Phase II COVID-19 Study

Retrieved on: 
Friday, May 8, 2020
Health, Medical statistics, Clinical research, Medical research, Articles, Clinical trials, Pluristem Therapeutics, Technion – Israel Institute of Technology, Clinical endpoint, Endpoint

The primary efficacy endpoint of the study is the number of ventilator free days during the 28 days from day 1 through day 28 of the study.

Key Points: 
  • The primary efficacy endpoint of the study is the number of ventilator free days during the 28 days from day 1 through day 28 of the study.
  • The primary endpoint determination will be performed at the end of the 28 day main study period.
  • A Clinical Trial Authorization (CTA) has also been filed in Europe for a Phase II COVID-19 trial, with the first European clinical sites planned in Germany and Italy.
  • For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

First Patients Dosed in Phase 2/3 Randomized Controlled Trial of Mesoblast’s Remestemcel-l for COVID-19 Acute Respiratory Distress Syndrome

Retrieved on: 
Wednesday, May 6, 2020
Clinical research, Health, Medical specialties, Branches of biology, Mesoblast, Regenerative biomedicine, Food and Drug Administration, Medical statistics, Acute respiratory distress syndrome, Investigational New Drug, Clinical endpoint

Mesoblast holds an Investigational New Drug (IND) application cleared by the FDA for use of remestemcel-L in the treatment of patients with COVID-19 ARDS.

Key Points: 
  • Mesoblast holds an Investigational New Drug (IND) application cleared by the FDA for use of remestemcel-L in the treatment of patients with COVID-19 ARDS.
  • The primary endpoint is all-cause mortality within 30 days of randomization, with the key secondary endpoint being the number of days alive and off mechanical support.
  • We expect quick enrollment in this trial to determine whether remestemcel-L can reduce mortality in these patients.
  • Mesoblast is completing Phase 3 trials for its product candidates for advanced heart failure and chronic low back pain.