Placebo-controlled study

Aptinyx Recommences Patient Recruitment in Phase 2 Study of NYX-2925 in Patients with Fibromyalgia

Monday, September 28, 2020 - 1:27pm

Aptinyx Inc. (Nasdaq: APTX), a clinical-stage biopharmaceutical company developing transformative therapies for the treatment of brain and nervous system disorders, today announced that it has re-activated study sites and recommenced patient recruitment in a Phase 2 study of NYX-2925 in patients with fibromyalgia.

Key Points: 
  • Aptinyx Inc. (Nasdaq: APTX), a clinical-stage biopharmaceutical company developing transformative therapies for the treatment of brain and nervous system disorders, today announced that it has re-activated study sites and recommenced patient recruitment in a Phase 2 study of NYX-2925 in patients with fibromyalgia.
  • We are very pleased to be restarting this study, said Norbert Riedel, Ph.D., president and chief executive officer of Aptinyx.
  • It will build on the positive results from our first Phase 2 evaluation of NYX-2925 in patients with fibromyalgia.
  • The Phase 2 study is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of NYX-2925 in patients with fibromyalgia.

OliX Pharmaceuticals Announces IND Submission to U.S. FDA to Evaluate the Efficacy of OLX10010 in Phase 2a Clinical Trial

Friday, September 25, 2020 - 2:00am

Currently, there is no FDA-approved drugs and few treatments supported by well-designed prospective studies.

Key Points: 
  • Currently, there is no FDA-approved drugs and few treatments supported by well-designed prospective studies.
  • The purpose of this prospective, randomized, double-blind, intra-subject, placebo-controlled Phase 2a study is to determine the efficacy of OLX10010 in reducing recurrence of hypertrophic scars.
  • The Phase 2a trial follows the successful completion of OLIXs Phase 1 trial in the U.K. in November of 2019.
  • OliX Pharmaceuticals is a clinical stage pharmaceutical company developing therapeutics against a variety of disorders by down-regulating expression of disease-causing genes, based on its own proprietary RNAi technology.

OncoImmune’s SACCOVID™ (CD24Fc) Exhibits Superb Therapeutic Efficacy—A Potential Breakthrough in Treating Severe and Critical COVID-19

Thursday, September 24, 2020 - 1:00pm

The SAC-COVID Phase III clinical trial is randomized, placebo-controlled and blinded to participants, the clinical teams, the investigators, and the Sponsor.

Key Points: 
  • The SAC-COVID Phase III clinical trial is randomized, placebo-controlled and blinded to participants, the clinical teams, the investigators, and the Sponsor.
  • The pre-specified interim efficacy and safety analyses were performed when 146 patients achieved clinical recovery from COVID-19, a milestone achieved with 203 enrollments.
  • The trial was opened in April this year and was activated in 15 medical centers in the US.
  • The very large therapeutic effect of SACCOVIDTM observed potentially represents a major breakthrough in COVID-19 therapy.

Cytokinetics Announces Initiation of Phase 1 Clinical Study of CK-3772271

Wednesday, September 23, 2020 - 12:30pm

The primary objective of this Phase 1 placebo-controlled, single ascending dose clinical study in healthy adults is to assess the safety and tolerability of CK-271.

Key Points: 
  • The primary objective of this Phase 1 placebo-controlled, single ascending dose clinical study in healthy adults is to assess the safety and tolerability of CK-271.
  • The study design includes three cohorts, with 8 adults per cohort randomized (6:2) in a blinded fashion to CK-271 or placebo.
  • Cytokinetics is conducting REDWOOD-HCM, a Phase 2 clinical trial of CK-274 in patients with obstructive HCM.
  • For further information regarding these and other risks related to Cytokinetics business, investors should consult Cytokinetics filings with the Securities and Exchange Commission.

ViralClear Expands Ongoing Phase 2 Trial Size for its Oral Anti-Viral for the Treatment of COVID-19, Expands Trial Locations and Appoints Contract Manufacturing Organization to Manufacture Phase 3 Supplies of Merimepodib Oral Solution

Tuesday, September 22, 2020 - 3:55pm

The size of the ongoing randomized, double-blind, placebo-controlled Phase 2 trial of merimepodib in combination with remdesivir is being increased from 40 to 80 subjects.

Key Points: 
  • The size of the ongoing randomized, double-blind, placebo-controlled Phase 2 trial of merimepodib in combination with remdesivir is being increased from 40 to 80 subjects.
  • However, based on a review of blinded data from the ongoing trial, subjects with scores of 3 and 4 are showing distinct differences.
  • The merimepodib monotherapy trial to be conducted in the outpatient setting will be initiated after the completion of the current Phase 2 combination trial.
  • Andrew Ballou BioSig Technologies, Inc. Vice President, Investor Relations 54 Wilton Road, 2nd floor Westport, CT 06880 aballou@biosigtech.com 203-409-5444, x133

Genentech’s Phase III EMPACTA Study Showed Actemra Reduced the Likelihood of Needing Mechanical Ventilation in Hospitalized Patients With COVID-19 Associated Pneumonia

Friday, September 18, 2020 - 6:00am

The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the Actemra arm versus 19.3% in the placebo arm.

Key Points: 
  • The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the Actemra arm versus 19.3% in the placebo arm.
  • Actemra is currently being investigated as a potential treatment for COVID-19 associated pneumonia, including in combination with an anti-viral in the Phase III REMDACTA clinical trial.
  • Results from the Phase III COVACTA trial in patients with severe COVID-19 associated pneumonia were released in July.
  • EMPACTA (Evaluating Minority Patients with Actemra) is a Phase III, randomized, double-blind, placebo-controlled multicenter study (EMPACTA, NCT04372186) to evaluate the efficacy and safety of Actemra in the treatment of hospitalized COVID-19 associated pneumonia among patients that are often underrepresented in clinical trials.

Atossa Therapeutics Receives Second Positive Interim Safety Assessment in Clinical Study of AT-301 Nasal Spray Being Developed for the Coronavirus Causing COVID

Thursday, September 17, 2020 - 2:30pm

This second group of eight participants received a single escalated dose of either AT-301A (placebo) or AT-301B (active drug).

Key Points: 
  • This second group of eight participants received a single escalated dose of either AT-301A (placebo) or AT-301B (active drug).
  • Based on rapid enrollment in the first half of the study, we expect to complete enrollment in the remainder of the study very quickly.
  • We anticipate that our AT-301 nasal spray will complement any traditional COVID-19 vaccine that may be developed, added Dr. Quay.
  • The ongoing Phase 1 study is a double-blinded, randomized, and placebo-controlled safety study of AT-301 nasal spray in 32 healthy adult subjects divided into two study groups.

Galera Therapeutics Announces Dosing of First Patient in a Randomized, Double-Blind Pilot Phase 2 Clinical Trial of GC4419 for COVID-19

Wednesday, September 16, 2020 - 1:00pm

The randomized, double-blind, placebo-controlled Phase 2 trial is designed to assess the safety and efficacy of GC4419 in improving 28-day mortality, compared to placebo.

Key Points: 
  • The randomized, double-blind, placebo-controlled Phase 2 trial is designed to assess the safety and efficacy of GC4419 in improving 28-day mortality, compared to placebo.
  • The trial will enroll up to 50 hospitalized adult patients critically ill with COVID-19 at several sites across the U.S.
  • Patients in the trial will receive 90 mg of GC4419 or placebo by infusion twice daily for seven days.
  • The trial will also collect additional data related to the requirement for intensive care, mechanical ventilation, and organ function.

DGAP-News: Positive Results from Adrenomed's AdrenOSS-2 Phase II trial evaluating Adrecizumab (HAM8101) in Septic Shock presented during e-ISICEM

Wednesday, September 16, 2020 - 7:00am

[1]

Key Points: 
  • [1]
    The AdrenOSS-2 Phase II trial ( NCT03085758 [2] ) achieved its primary endpoint: No differences in serious or possibly related Treatment Emergent Adverse Events (TEAEs) between Adrecizumab and placebo were observed.
  • As already demonstrated in previous Phase I trials, Adrecizumab exhibited a favorable safety and tolerability profile in septic shock patients.
  • [3]
    28-day all-cause mortality analysis including all patients (n=301) showed a trend towards a survival benefit for Adrecizumab treated patients.
  • Adrecizumab has successfully completed a biomarker-guided, double-blinded, placebo-controlled, randomized, multicenter proof-of-concept Phase II trial with 301 patients suffering from septic shock.

89bio Announces Positive Topline Results from its Phase 1b/2a Trial of BIO89-100 in NASH

Monday, September 14, 2020 - 12:01pm

Baseline liver fat levels and changes in liver fat were similar in biopsy-confirmed NASH and phenotypical NASH subjects.

Key Points: 
  • Baseline liver fat levels and changes in liver fat were similar in biopsy-confirmed NASH and phenotypical NASH subjects.
  • This study was a randomized, double-blind, placebo-controlled, multiple ascending dose-ranging trial in biopsy-proven NASH or phenotypical NASH (PNASH) subjects.
  • BIO89-100 is also being developed for the treatment of severe hypertriglyceridemia (SHTG) and is currently in a Phase 2 trial.
  • 89bio claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements.