Placebo-controlled study

Madrigal Pharmaceuticals Offers Patients Resmetirom in a Planned Open Label Active Treatment Extension of the Phase 3 MAESTRO-NAFLD-1 Clinical Study

Retrieved on: 
Tuesday, July 13, 2021
Clinical research, Medical specialties, Hepatitis, Medicine, Clinical medicine, Non-alcoholic fatty liver disease, Fatty liver disease, Placebo-controlled study, Placebo

CONSHOHOCKEN, Pa., July 13, 2021 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) announced today its first patient dosed in a planned 52-week open label active treatment extension study of MAESTRO-NAFLD-1, named MAESTRO-NAFLD-1-Open Label Extension (OLE) (NCT04951219).

Key Points: 
  • CONSHOHOCKEN, Pa., July 13, 2021 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) announced today its first patient dosed in a planned 52-week open label active treatment extension study of MAESTRO-NAFLD-1, named MAESTRO-NAFLD-1-Open Label Extension (OLE) (NCT04951219).
  • MAESTRO-NAFLD-1 is an ongoing 52-week ~1200 patient Phase 3 non-invasive, multi-center, double-blind, randomized, placebo-controlled study of resmetirom in patients with non-alcoholic fatty liver disease (NAFLD), presumed NASH.
  • MAESTRO-NAFLD-OLE allows patients who complete MAESTRO-NAFLD-1 to consent to 52 weeks of active treatment with resmetirom, making this treatment available to patients who were assigned to placebo in the main study and allowing patients who were on resmetirom to continue treatment with the drug.
  • Patients and physicians participating in MAESTRO-NAFLD-1 are enthusiastic about the opportunity to continue active treatment with resmetirom in the extension study, stated Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal.

Atossa Therapeutics Receives Regulatory Approval To Open Clinical Study of AT-H201 in Australia

Retrieved on: 
Wednesday, July 7, 2021
Health sciences, Health, Clinical research, Design of experiments, Medical research, Drug discovery, Pharmaceutical industry, Clinical trials, Placebo-controlled study, COVID-19

If the initial parts of the study are successful we will study the efficacy of our proprietary AT-H201 on moderately ill COVID-19 patients who can be treated via a nebulizer.

Key Points: 
  • If the initial parts of the study are successful we will study the efficacy of our proprietary AT-H201 on moderately ill COVID-19 patients who can be treated via a nebulizer.
  • Up to one third of hospitalized patients have pulmonary function changes 60 days or more after recovering from COVID.
  • The Phase 1/2a placebo-controlled study will enroll a total of 60 healthy participants and moderately-ill hospitalized COVID-19 patients.
  • The Phase 1/2a study in Australia and other clinical studies must be successfully completed and regulatory approvals must be obtained before AT-H201 may be commercialized.

Ascendis Pharma A/S Announces Target Enrollment Achieved in the Phase 3 PaTHway Trial of TransCon™ PTH (palopegteriparatide) in Adults with Hypoparathyroidism (HP) and Provides a Comprehensive Global Clinical Program Update

Retrieved on: 
Tuesday, July 6, 2021
Clinical trials, Clinical research, Design of experiments, Placebo-controlled study

The durable benefit demonstrated in our phase 2 PaTH Forward Trial Week 58 data supports the use of TransCon PTH as a potential new treatment paradigm for adults with HP.

Key Points: 
  • The durable benefit demonstrated in our phase 2 PaTH Forward Trial Week 58 data supports the use of TransCon PTH as a potential new treatment paradigm for adults with HP.
  • We are pleased to continue extending the global clinical reach for TransCon PTH for all HP patients as a key component of our Vision 3x3.
  • The PaTHway Trial is a phase 3, randomized, double-blind, placebo-controlled trial in North America and Europe evaluating the safety, tolerability, and efficacy of palopegteriparatide in adults with HP.
  • Ascendis,Ascendis Pharma, theAscendis Pharmalogo, the company logo and TransCon are trademarks owned by theAscendis Pharma Group.

Athira Pharma Announces Initiation of Open Label Extension Study for LIFT-AD and ACT-AD Clinical Trials of ATH-1017 for Alzheimer’s Disease

Retrieved on: 
Tuesday, July 6, 2021
Health sciences, Health, Clinical research, Medicine, Design of experiments, Cognitive disorders, Learning disabilities, Psychiatric diagnosis, Dementia, Placebo-controlled study, Clinical trial, Placebo

The data we will continue to collect in this open label extension could help us to better understand the long-term safety and efficacy profile of ATH-1017 and could help Athira best design future clinical trials of ATH-1017.

Key Points: 
  • The data we will continue to collect in this open label extension could help us to better understand the long-term safety and efficacy profile of ATH-1017 and could help Athira best design future clinical trials of ATH-1017.
  • The randomized, double-blind, placebo-controlled trials are evaluating the safety and efficacy of ATH-1017 in mild-to-moderate Alzheimers disease.
  • Patients in both trials are being evaluated for improvement in cognition, global and functional assessments comparing treatment arms to placebo.
  • In addition to Alzheimers disease, ATH-1017 is designed to address the broader dementia population, including Parkinsons disease dementia.

DGAP-News: Marinomed Biotech AG Reports Encouraging Topline Data for Phase II Clinical Trial of Tacrosolv in Allergic Rhinoconjunctivitis

Retrieved on: 
Thursday, July 1, 2021
Clinical trials, Clinical research, Design of experiments, Medical specialties, Placebo-controlled study, Allergic conjunctivitis, Health, Medicine, Marinosolv, Marinomed Biotech AG, MARINOSOLV, MARINOMED BIOTECH AG

The placebo-controlled Phase II clinical trial was conducted at the Vienna Challenge Chamber (Austria) to assess safety and efficacy of two different dose of Tacrosolv in a crossover design.

Key Points: 
  • The placebo-controlled Phase II clinical trial was conducted at the Vienna Challenge Chamber (Austria) to assess safety and efficacy of two different dose of Tacrosolv in a crossover design.
  • These results indicate the high potential of tacrolimus being an effective treatment of ocular inflammation exemplified by allergic conjunctivitis and other allergic manifestations.
  • The study was conducted as a randomized, placebo-controlled, crossover, double-blind, single site Phase II clinical trial.
  • Marinomed Biotech AG (Korneuburg, Austria) (VSE:MARI) is an Austrian science-based biotech company with globally marketed therapeutics listed on the Prime Market of the Vienna Stock Exchange.

Novome Biotechnologies Initiates Phase 1/2a Study to Evaluate Therapeutically Engineered Bacteria for the Treatment of Enteric Hyperoxaluria

Retrieved on: 
Wednesday, June 30, 2021
Hyperoxaluria, Placebo-controlled study, Medicine, Health sciences, Clinical medicine

Patients with enteric hyperoxaluria are at increased risk of developing kidney stones and, in more severe cases, chronic kidney disease and kidney failure.

Key Points: 
  • Patients with enteric hyperoxaluria are at increased risk of developing kidney stones and, in more severe cases, chronic kidney disease and kidney failure.
  • We are eager to see the results of this groundbreaking study and its potential to validate our approach to controllably and safely colonize the human gut with therapeutically engineered bacteria.
  • The Phase 1/2a clinical trial is designed to evaluate NOV-001 in healthy volunteers and patients with enteric hyperoxaluria.
  • The second stage of the study, Phase 2a, is a prospective, randomized, single-blinded, placebo-controlled study of the safety, tolerability and early efficacy in patients with enteric hyperoxaluria.

Madrigal Pharmaceuticals Completes Enrollment of the 52 Week Liver Biopsy Patient Population in the Phase 3 MAESTRO-NASH Study of Resmetirom

Retrieved on: 
Wednesday, June 30, 2021
Health sciences, Clinical research, Design of experiments, Health, Medical research, Hepatitis, Non-alcoholic fatty liver disease, Placebo-controlled study, Clinical trial, TIMI

Madrigal will continue to enroll additional patients beyond those required for accelerated approval to provide for the clinical outcomes portion of the MAESTRO-NASH Phase 3 clinical trial of resmetirom.

Key Points: 
  • Madrigal will continue to enroll additional patients beyond those required for accelerated approval to provide for the clinical outcomes portion of the MAESTRO-NASH Phase 3 clinical trial of resmetirom.
  • We expect that the timing of the MAESTRO-NASH study will enable us to report topline 52-week data by the third quarter of 2022.
  • Madrigal is currently conducting two Phase 3 Clinical trials, MAESTRO-NASH and MAESTRO-NAFLD-1, to demonstrate the safety and efficacy of resmetirom for the treatment of NASH.
  • MAESTRO-NASH is a Phase 3 multi-center, double-blind, randomized, placebo-controlled study of resmetirom in patients with liver biopsy confirmed NASH and was initiated in March 2019.

Retrotope Announces Initiation of Phase 2 Study of RT001 in Patients with Progressive Supranuclear Palsy (PSP)

Retrieved on: 
Wednesday, June 30, 2021
Clinical research, Biochemistry, Di-deuterated linoleic acid ethyl ester, Chemistry, Physical sciences, Medical research, Design of experiments, Placebo-controlled study, Placebo, Retrotope

The Phase 2 trial is a randomized, double-blind, placebo-controlled study evaluating the efficacy, long-term safety and tolerability of RT001 in patients with PSP.

Key Points: 
  • The Phase 2 trial is a randomized, double-blind, placebo-controlled study evaluating the efficacy, long-term safety and tolerability of RT001 in patients with PSP.
  • Study investigators will enroll and randomize approximately 40 patients to receive either RT001 or placebo daily for 48 weeks.
  • Additionally, study investigators will also evaluate the efficacy of RT001 using a second PSP rating scale suggested by the United States Food and Drug Administration (FDA).
  • The study also includes several secondary and exploratory endpoints intended to further elucidate the efficacy and safety profile of RT001 as compared to placebo.

Alnylam Initiates KARDIA-1 Phase 2 Study of Zilebesiran (ALN-AGT) in Patients with Mild-to-Moderate Hypertension

Retrieved on: 
Wednesday, June 30, 2021
Health, Clinical trials, Research, Pharmaceutical, Science, Biotechnology, Blood pressure, Hypertension, Placebo-controlled study, Medical research, Health, TIMI, KARDIA-1 Phase 2 Study, Zilebesiran, Hypertension, RNAi, Alnylam Pharmaceuticals, KARDIA-1 PHASE 2 STUDY, ZILEBESIRAN, HYPERTENSION, RNAI, ALNYLAM PHARMACEUTICALS

The study initiation is based on encouraging Phase 1 data, including results presented earlier this year at the 2021 Joint Meeting of the European Society of Hypertension (ESH) and the International Society of Hypertension (ISH).

Key Points: 
  • The study initiation is based on encouraging Phase 1 data, including results presented earlier this year at the 2021 Joint Meeting of the European Society of Hypertension (ESH) and the International Society of Hypertension (ISH).
  • According to the World Health Organization, hypertension is the largest modifiable risk factor for cardiovascular morbidity and mortality.
  • The KARDIA-1 Phase 2 trial is a randomized, double-blind (DB), placebo-controlled, dose-ranging study to evaluate the efficacy and safety of zilebesiran as monotherapy in adults with mild-to-moderate hypertension.
  • Patients who receive placebo will be randomized to one of the four initial zilebesiran dose regimens beginning at month six.

Cerevel Therapeutics Announces Positive Topline Results for CVL-231 in Phase 1b Clinical Trial in Patients with Schizophrenia

Retrieved on: 
Tuesday, June 29, 2021
Clinical research, Design of experiments, Knowledge, Methodology, Research, Schizophrenia, Experiments, Randomized controlled trial, Placebo-controlled study

The results of this trial support the advancement of CVL-231 into a Phase 2 program in schizophrenia.

Key Points: 
  • The results of this trial support the advancement of CVL-231 into a Phase 2 program in schizophrenia.
  • Part B was a randomized, double-blind, three-arm, placebo-controlled trial with the objective of further evaluating safety, PK and preliminary PD.
  • Schizophrenia is also often associated with significant cognitive impairment, which further limits a patients ability to be gainfully employed and maintain relationships.
  • The live webcast and accompanying slides can be accessed on the investor relations section of the Cerevel Therapeutics website here .