Placebo-controlled study

SAB Biotherapeutics Doses First Participant in Phase 2a Trial of SAB-176 for the Treatment of Influenza

Retrieved on: 
Friday, July 2, 2021
Health, Infectious diseases, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Drugs, Monoclonal antibodies, Antibodies, Medical research, Neutralizing antibody, Placebo-controlled study, Health sciences, Health, Infectious diseases, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Drugs, Monoclonal antibodies, Antibodies, Medical research, Neutralizing antibody, Placebo-controlled study, Health sciences, SAB-176, Seasonal Influenza, SAB Biotherapeutics, Inc., SAB-176, SEASONAL INFLUENZA, SAB BIOTHERAPEUTICS, INC.

The Phase 2a trial is a randomized, double-blind, placebo-controlled study that will evaluate the safety and treatment efficacy of SAB-176 in 60 healthy adults challenged with a pandemic influenza virus strain (pH1N1).

Key Points: 
  • The Phase 2a trial is a randomized, double-blind, placebo-controlled study that will evaluate the safety and treatment efficacy of SAB-176 in 60 healthy adults challenged with a pandemic influenza virus strain (pH1N1).
  • SAB-176 is also being evaluated in an ascending dose, double-blind, randomized, placebo-controlled Phase 1 safety trial in healthy volunteers.
  • SAB-176 is a multivalent, broadly neutralizing fully-human polyclonal antibody therapeutic candidate in development for the treatment, or prevention, of severe influenza.
  • SAB Biotherapeutics, Inc. (SAB) is a clinical-stage biopharmaceutical company advancing a new class of immunotherapies based on its human polyclonal antibodies.

Peer Reviewed Article Highlights Efficacy and Safety of Jeuveau® in Patients with Skin of Color

Retrieved on: 
Thursday, June 24, 2021
Health sciences, Clinical research, Design of experiments, Health, Medical research, Clinical trials, Food and Drug Administration, Pharmaceutical industry, Placebo-controlled study

Patients with SOC differ from those without SOC in several important ways, including skin structure and the pathophysiology of aging.

Key Points: 
  • Patients with SOC differ from those without SOC in several important ways, including skin structure and the pathophysiology of aging.
  • Were pleased that Jeuveau is proven to be a safe and effective option for patients with skin of color who are looking for neurotoxin treatment.
  • The article focuses on pooled data from 492 Jeuveau-treated patients who participated in two US multicenter, randomized, double-blind, placebo-controlled, single-dose phase III clinical studies.
  • Responder rates among patients with SOC (n = 140) were lower than those without SOC (n = 352), by 5.9% on average across all visits.

Gliknik Inc. Raises $11.5 Million in Series C Financing

Retrieved on: 
Thursday, June 24, 2021
Research, Infectious diseases, Genetics, Clinical trials, Biotechnology, Health, Pharmaceutical, Science, Oncology, Animal virology, Feline immunodeficiency virus, Lentiviruses, Placebo-controlled study, Immunology, Health sciences, Health, Medicine

Gliknik Inc. , an immunology company dedicated to patients with cancer and autoimmune disorders, today announced that it has successfully completed an $11.5 million Series C Preferred Stock financing.

Key Points: 
  • Gliknik Inc. , an immunology company dedicated to patients with cancer and autoimmune disorders, today announced that it has successfully completed an $11.5 million Series C Preferred Stock financing.
  • First In Ventures (FIV) led the Series C with SAISO Partners and affiliates of RDA Ventures and Garden Street Holdings also participating.
  • We believe that Gliknik has created several potential best-in-class mid-stage assets, said Scott Roth, managing partner of FIV.
  • Funding will help advance Gliknik clinical and pre-clinical programs, including:
    A randomized double-blind, placebo-controlled phase 2 study of Gliknik immuno-oncology compound biropepimut-S , which is nearing completion.

Longeveron Announces Abstract Highlighting Data from Phase 1 Alzheimer’s Disease Trial Accepted for Developing Topics Presentation at the 2021 Annual Alzheimer's Association International Conference

Retrieved on: 
Thursday, June 24, 2021
Health sciences, Clinical research, Design of experiments, Health, Medical research, Clinical trials, Placebo-controlled study

The abstract is titled Safety and Efficacy of Lomecel-B in Patients with Mild Alzheimers Disease: Results of a Double-Blinded, Randomized, Placebo-Controlled, Phase 1 Clinical Trial.

Key Points: 
  • The abstract is titled Safety and Efficacy of Lomecel-B in Patients with Mild Alzheimers Disease: Results of a Double-Blinded, Randomized, Placebo-Controlled, Phase 1 Clinical Trial.
  • This 33 subject study was supported by two competitive Part the Cloud Challenge on Neuroinflammation grants from the Alzheimers Association.
  • The trial met its primary endpoint of demonstrating safety and feasibility, and importantly, no Alzheimers Related Imaging Abnormalities (ARIA), after infusion with Lomecel-B.
  • As a result, we look forward to advancing Lomecel-B into a Phase 2 clinical trial in the second half of 2021.

Brickell Biotech Announces Initiation of a Phase 1 Study of Sofpironium Bromide Gel in Primary Palmoplantar Hyperhidrosis Patients by its Development Partner, Kaken Pharmaceutical in Japan

Retrieved on: 
Thursday, June 24, 2021
Clinical research, Health sciences, Health, Medical research, Design of experiments, Hyperhidrosis, Thoracic surgery, Placebo-controlled study, Placebo, Clinical trial

In Japan, 5.33% and 2.79% of the population are estimated to be affected by primary palmar and plantar hyperhidrosis, respectively1.

Key Points: 
  • In Japan, 5.33% and 2.79% of the population are estimated to be affected by primary palmar and plantar hyperhidrosis, respectively1.
  • Depending on the outcome of the Phase 1 study, Kaken and Brickell will determine the next steps, if any, for the development of sofpironium bromide gel in PPH patients in their respective territories.
  • Phase 3 pivotal program for sofpironium bromide gel, 15% which is comprised of two pivotal clinical studies, Cardigan I and Cardigan II.
  • Both randomized, double-blinded, placebo-controlled pivotal studies are evaluating sofpironium bromide gel, 15% vs. placebo (1:1 ratio) in approximately 350 subjects (per study) aged nine and older with primary axillary hyperhidrosis.

Oyster Point Pharma Announces Enrollment of First Subject in the OLYMPIA Phase 2 Clinical Trial of OC-01 (varenicline) Nasal Spray for Patients with Neurotrophic Keratopathy

Retrieved on: 
Monday, June 21, 2021
Clinical research, Design of experiments, Health sciences, Health, Medical research, Nicotinic agonists, Benzazepines, Smoking cessation, Varenicline, Placebo-controlled study, Clinical trial

Stage 1 NK patients may present with additional ocular surface issues, including dry eye disease, which affects 38 million1 patients.

Key Points: 
  • Stage 1 NK patients may present with additional ocular surface issues, including dry eye disease, which affects 38 million1 patients.
  • The OLYMPIA Phase 2 study is a multicenter, randomized, double-masked, placebo-controlled clinical trial to evaluate the safety and efficacy of OC-01 (varenicline) nasal spray in subjects with Mackies Classification Stage 1 Neurotrophic Keratopathy.
  • In this clinical trial, OC-01 (varenicline) nasal spray will be administered three times a day, as compared to placebo (vehicle) nasal spray.
  • Oyster Point Pharma is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies to treat ophthalmic diseases.

Anavex Life Sciences Announces ANAVEX®2-73 (Blarcamesine) Biomarker Correlated with Efficacy Endpoints in Placebo-Controlled U.S. Phase 2 Clinical Trial for the Treatment of Adult Patients with Rett Syndrome

Retrieved on: 
Monday, June 21, 2021
Branches of biology, Neurological disorders, Health, Autism, Rett syndrome, MECP2, Rett, Placebo-controlled study

Rett syndrome is caused by mutations in the MECP2 gene and strikes all racial and ethnic groups.

Key Points: 
  • Rett syndrome is caused by mutations in the MECP2 gene and strikes all racial and ethnic groups.
  • The population of patients with Rett syndrome is estimated to be approximately 11,000 patients in the U.S.
  • The Phase 2 trial is a randomized double-blind, placebo-controlled safety, tolerability, pharmacokinetic and efficacy study of oral liquid ANAVEX2-73 to treat Rett syndrome in a total of 31 adult patients with Rett syndrome over a 7-weeks treatment period (End of Trial, EOT) were evaluated incorporating precision medicine biomarkers.
  • Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.

Cassava Sciences Provides Mid-Year Corporate Update, Clinical Development Progress and Announces Guidance on Clinical Data Release

Retrieved on: 
Monday, June 21, 2021
Agriculture, Clinical research, Design of experiments, Placebo-controlled study, Cassava, Branches of biology, Food and drink

In March 2020, Cassava Sciences initiated a long-term, open-label study to evaluate simufilam in patients with Alzheimers disease.

Key Points: 
  • In March 2020, Cassava Sciences initiated a long-term, open-label study to evaluate simufilam in patients with Alzheimers disease.
  • In May 2021, Cassava Sciences initiated a double-blind, randomized, placebo-controlled study in patients with Alzheimers disease called the Cognition Maintenance Study (CMS).
  • This affords Cassava Sciences a financial runway to support the Phase 3 clinical development program of simufilam.
  • Over the past 10 years, Cassava Sciences has combined state-of-the-art technology with new insights in neurobiology to develop novel solutions for Alzheimers disease.

Dicerna Initiates Patient Dosing in ESTRELLA Phase 2 Clinical Trial of Belcesiran for the Treatment of Alpha-1 Antitrypsin Deficiency-Associated Liver Disease

Retrieved on: 
Tuesday, June 22, 2021
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Genetics, Clinical research, Design of experiments, Health sciences, Health, Medical research, Clinical trials, Food and Drug Administration, Pharmaceutical industry, Placebo-controlled study, Draft:PPP001, Palifermin, Alpha-1 Antitrypsin Deficiency and Alpha-1 Antitrypsin Deficiency-Associated Liver Disease (AATLD), Belcesiran, RNAi and Dicerna’s GalXC™ RNAi Platform, Dicerna Pharmaceuticals, Inc., ALPHA-1 ANTITRYPSIN DEFICIENCY AND ALPHA-1 ANTITRYPSIN DEFICIENCY-ASSOCIATED LIVER DISEASE (AATLD), BELCESIRAN, RNAI AND DICERNA’S GALXC™ RNAI PLATFORM, DICERNA PHARMACEUTICALS, INC.

We are very pleased to have now begun patient dosing in our Phase 2 ESTRELLA trial to better understand belcesirans potential to treat the underlying cause of AATLD.

Key Points: 
  • We are very pleased to have now begun patient dosing in our Phase 2 ESTRELLA trial to better understand belcesirans potential to treat the underlying cause of AATLD.
  • ESTRELLA ( NCT04764448 ) is a randomized, multidose, double-blind, placebo-controlled Phase 2 trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of belcesiran in participants with AATLD.
  • The ESTRELLA clinical trial is part of Dicernas SHINE clinical development program to evaluate the safety and efficacy of belcesiran, formerly known as DCR-A1AT, for the treatment of AATLD.
  • A Phase 1 trial of multiple doses of belcesiran in healthy volunteers is ongoing, with initial data from the Phase 1 trial expected in mid-2021.

Inhibrx Initiates a Potential Registration-Enabling Phase 2 Study of INBRX-109 in Conventional Chondrosarcoma Patients, Updates Data for Ongoing Phase 1 Study and Announces Amended Loan Agreement with Oxford

Retrieved on: 
Monday, June 21, 2021
Health, Clinical research, Design of experiments, Medical research, Chondrosarcoma, Sarcoma, Bone tumor, Clinical trial, Placebo-controlled study

Chondrosarcoma is an orphan bone cancer with approximately 2,800 new patients diagnosed annually in the United States and the European Union.

Key Points: 
  • Chondrosarcoma is an orphan bone cancer with approximately 2,800 new patients diagnosed annually in the United States and the European Union.
  • Inhibrx provided updated results from an ongoing Phase 1 clinical trial evaluating the efficacy and safety of INBRX-109 in patients with conventional chondrosarcoma.
  • Additional data will be presented at the Annual Connective Tissue Oncology Society (CTOS) Conference taking place on November 10-13, 2021.
  • A randomized, blinded, placebo-controlled, potential registration-enabling Phase 2 trial of INBRX-109 in conventional chondrosarcoma initiated this month.