Placebo-controlled study

MindMed and Liechti Lab in Basel Switzerland Publish First Pharmacogenetic Data on LSD to Help Guide Personalized Dosing

Retrieved on: 
Wednesday, May 26, 2021

The study results from a pooled secondary analysis of four Phase 1 studies that each used a randomized, double-blind, placebo-controlled, crossover design and were conducted at the University Hospital Basel Liechti Lab, in Basel, Switzerland.

Key Points: 
  • The study results from a pooled secondary analysis of four Phase 1 studies that each used a randomized, double-blind, placebo-controlled, crossover design and were conducted at the University Hospital Basel Liechti Lab, in Basel, Switzerland.
  • The results of this study indicate that pharmacogenetic testing prior to LSD-assisted treatment may inform LSD dose selection at the individual patient level.
  • Dr. Matthias Liechti said, "This is the first data on the pharmacogenetics of LSD.
  • Such information is important for the further development of LSD into a medication and could ultimately help to personalize patient treatment."

Karyopharm Announces Open Enrollment At Participating Hospitals In Europe For A Phase 3 Maintenance Study Evaluating Selinexor In Patients With Endometrial Cancer After Combination Chemotherapy

Retrieved on: 
Wednesday, May 26, 2021

The KCP-330-024/ENGOT-EN5/SIENDOstudy is an ongoing multicenter, blinded, placebo-controlled, randomized Phase 3 study evaluating the efficacy and safety for front-line maintenance therapy with selinexor in patients with advanced or recurrent endometrial cancer.

Key Points: 
  • The KCP-330-024/ENGOT-EN5/SIENDOstudy is an ongoing multicenter, blinded, placebo-controlled, randomized Phase 3 study evaluating the efficacy and safety for front-line maintenance therapy with selinexor in patients with advanced or recurrent endometrial cancer.
  • The study is expected to enroll approximately 248 participants at study sites across the United States, Canada, Israel and Europe.
  • The primary endpoint in the study is progression free survival with the goal of the study demonstrating a hazard ratio of 0.6.
  • XPOVIO and NEXPOVIO are registered trademarks of Karyopharm Therapeutics Inc. Velcade is a registered trademark of Takeda Pharmaceutical Company Limited.

DGAP-News: APEIRON Biologics' APN01 selected for large-scale US trial in COVID-19

Retrieved on: 
Wednesday, May 19, 2021

The trial is largely funded by public grants.\nAPEIRON\'s recently completed Phase 2 trial showed significant improvement in certain parameters of the Renin Angiotensin Aldosterone System (RAAS) with APN01 treatment compared to placebo.

Key Points: 
  • The trial is largely funded by public grants.\nAPEIRON\'s recently completed Phase 2 trial showed significant improvement in certain parameters of the Renin Angiotensin Aldosterone System (RAAS) with APN01 treatment compared to placebo.
  • Data also suggested that APN01 will confer greatest therapeutic benefit to patients with lower WHO scores.
  • The randomized, double-blinded, placebo controlled ACTIV-4d RAAS trial will enroll approximately 1,600 hospitalized patients with COVID-19, at more than 50 individual sites.
  • APN01 will be one of at least three agents to be evaluated in the trial.\n"We are highly motivated and honored, that APN01 was selected for this government funded US program.

Seelos Therapeutics Announces Positive Topline Data from the Open-Label Study of SLS-002 (Intranasal Racemic Ketamine), Demonstrating a Significant Treatment Effect and a Well Tolerated Safety Profile for Acute Suicidal Ideation and Behavior in Patients w

Retrieved on: 
Monday, May 17, 2021

b'The study is a multicenter, two-part clinical trial, comprised of an open-label cohort followed by a randomized, double-blind, placebo-controlled study.

Key Points: 
  • b'The study is a multicenter, two-part clinical trial, comprised of an open-label cohort followed by a randomized, double-blind, placebo-controlled study.
  • Subjects will return to the clinic to receive study drug and to undergo study assessments two times per week until Day 16.
  • Subjects will be evaluated for efficacy using multiple psychometric scales and for safety using clinical laboratory assessments, electrocardiograms (ECGs), vital signs, and physical examinations.
  • SLS-002 was originally derived from a Javelin Pharmaceuticals, Inc./Hospira, Inc. program with 16 clinical studies involving approximately 500 subjects.

Akero Therapeutics Reports First Quarter 2021 Financial Results and Provides Business Update

Retrieved on: 
Thursday, May 13, 2021

"Our histology results, as well as non-invasive markers of fibrosis, indicate that efruxifermin (EFX) acts both directly and indirectly to rapidly reverse fibrosis.

Key Points: 
  • "Our histology results, as well as non-invasive markers of fibrosis, indicate that efruxifermin (EFX) acts both directly and indirectly to rapidly reverse fibrosis.
  • Consistent data across three placebo-controlled clinical trials increase our confidence that EFX will be efficacious as a treatment for all stages of NASH.
  • All forward-looking statements contained in this press release speak only as of the date on which they were made.
  • Akero undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.\n'

Axcella Announces Initiation of EMMPACTSM Phase 2b Clinical Trial of AXA1125

Retrieved on: 
Tuesday, May 11, 2021

Given its multi-modal mechanism, the activity and tolerability seen in past clinical studies and the presumed safety of its underlying amino acids, AXA1125 holds the potential to serve as an ideal first-line NASH agent.

Key Points: 
  • Given its multi-modal mechanism, the activity and tolerability seen in past clinical studies and the presumed safety of its underlying amino acids, AXA1125 holds the potential to serve as an ideal first-line NASH agent.
  • We are excited to have EMMPACT underway and are eager to gauge AXA1125\xe2\x80\x99s histological impact.\xe2\x80\x9d\nAxcella has branded this global trial EMMPACT based on the potential for AXA1125, an EMM composition, to deliver meaningful, multifactorial clinical benefits to patients with NASH.
  • This randomized, double-blind, placebo-controlled, multi-center investigation will evaluate the efficacy and safety of AXA1125 in patients with biopsy-confirmed F2/F3 NASH.
  • AXA1125 is now in Phase 2b development.\nEMMs are a broad family of naturally occurring molecules, including amino acids, that regulate human metabolism.

Galera Reports First Quarter 2021 Financial Results and Recent Accomplishments

Retrieved on: 
Tuesday, May 11, 2021

\xe2\x80\x9cWe recently reported updated data from our placebo-controlled Phase 1/2 pilot trial, in which a near doubling of median overall survival was observed in patients with pancreatic cancer.

Key Points: 
  • \xe2\x80\x9cWe recently reported updated data from our placebo-controlled Phase 1/2 pilot trial, in which a near doubling of median overall survival was observed in patients with pancreatic cancer.
  • Building on the positive results from this trial, we anticipate initiating a Phase 2b trial in the first half of 2021 in patients with LAPC, with overall survival as the primary endpoint.
  • The Company expects to report topline data in the first half of 2022.\nResearch and development expenses were $12.4 million in the first quarter of 2021, compared to $14.3 million for the same period in 2020.
  • Galera also intends to initiate the GRECO-2 Phase 2b trial of GC4711 in combination with SBRT in patients with LAPC.

Prothena Announces Achievement of $60 Million Milestone From Roche for First Patient Dosed in Phase 2b Study of Prasinezumab in Early Parkinson’s Disease

Retrieved on: 
Monday, May 10, 2021

PADOVA is a Phase 2b, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of prasinezumab in patients with early Parkinson\xe2\x80\x99s disease who are on stable symptomatic medication.

Key Points: 
  • PADOVA is a Phase 2b, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of prasinezumab in patients with early Parkinson\xe2\x80\x99s disease who are on stable symptomatic medication.
  • The study will enroll approximately 575 patients, who will be randomized to receive either prasinezumab or placebo via intravenous infusion every 4 weeks.
  • Prasinezumab is designed to block the cell-to-cell transmission of the aggregated, pathogenic forms of alpha-synuclein in Parkinson's disease, thereby slowing clinical decline.
  • Prior to initiating clinical trials, the efficacy of prasinezumab was evaluated in various cellular and animal models of alpha-synuclein-related disease.

LB Pharmaceuticals To Participate in the B. Riley Securities’ Neuroscience Conference

Retrieved on: 
Monday, April 26, 2021

Following the presentation, Mr. Prensky will participate in a question-and-answer session.

Key Points: 
  • Following the presentation, Mr. Prensky will participate in a question-and-answer session.
  • Our approach is to create a research-focused organization dedicated to generating novel intellectual property around improved versions of these former best-selling drugs.
  • LB-102 has the potential to offer schizophrenia patients the benefits of amisulpride at a lower dose than amisulpride.
  • A first-in-human, double-blind placebo-controlled Phase 1 study designed to test the safety and pharmacokinetics of LB-102 was completed over the summer of 2020.

LivaNova and Verily Announce First Patient Enrolled in Study to Evaluate Treatment Effectiveness for Patients Living with Depression

Retrieved on: 
Monday, April 26, 2021

The Verily tools measure passive and active data, such as the participant\xe2\x80\x99s pulse rate, activity levels and sleep quality.

Key Points: 
  • The Verily tools measure passive and active data, such as the participant\xe2\x80\x99s pulse rate, activity levels and sleep quality.
  • The double-blind, randomized, placebo-controlled study is assessing how VNS Therapy can offer patients relief from their DTD symptoms and improve quality of life.
  • Symmetry\xc2\xae, the LivaNova VNS Therapy System for depression, is the first and only FDA-approved implantable device specifically designed for DTD.
  • LivaNova and Verily announced their collaboration on UNCOVER in February 2020.\nFor more information on the RECOVER clinical study, please visit www.RecoverVNS.com .