Placebo

Virios Therapeutics Presents Phase 2a Fibromyalgia Trial Data on Efficacy Analyses of Key Secondary Endpoints at the EULAR European Congress of Rheumatology

Retrieved on: 
Wednesday, June 2, 2021

Patients receiving IMC1 treatment reported significantly greater improvements versus placebo on the FIQR symptom items for stiffness, sleep quality, depression, and anxiety.

Key Points: 
  • Patients receiving IMC1 treatment reported significantly greater improvements versus placebo on the FIQR symptom items for stiffness, sleep quality, depression, and anxiety.
  • Improvements in patient global assessments and in fatigue assessments provide additional evidence for the beneficial effects of IMC1 on FM related symptoms.
  • Evidence of IMC-1s efficacy on a broad spectrum of FM outcome measures was previously demonstrated in a Phase 2a clinical trial.
  • These trial results are suggestive that IMC-1 may represent a new and novel treatment for fibromyalgia.

Medolife Rx Launches National TV PSA Campaign Promoting Escozine and Activates Customer Service Center

Retrieved on: 
Tuesday, June 1, 2021

Additionally, the company has activated a customer service center in the DR that will enable it to better serve the needs of patients in the region.

Key Points: 
  • Additionally, the company has activated a customer service center in the DR that will enable it to better serve the needs of patients in the region.
  • The campaign is designed to create awareness and interest in Escozine.
  • Upon approval from the committee, Medolife will conduct a controlled, double-blind placebo trial on humans to validate the efficacy of Escozine as a viable treatment.
  • Medolife is conducting clinical trials on Escozine as a treatment for COVID-19 in both the United States and the DR.

Humanigen Submits Application to FDA for Emergency Use Authorization for Lenzilumab in COVID-19

Retrieved on: 
Friday, May 28, 2021

Lenzilumab, should the FDA grant authorization, can address a critical unmet need for an effective treatment.

Key Points: 
  • Lenzilumab, should the FDA grant authorization, can address a critical unmet need for an effective treatment.
  • Lenzilumab achieved the primary endpoint with a 54% relative improvement in the likelihood of SWOV compared to placebo.
  • "We are excited and encouraged by these clinical results and are preparing to distribute lenzilumab if granted Emergency Use Authorization," said Edward P. Jordan, MBA, Chief Commercial Officer, Humanigen.
  • It is anticipated that thousands of patients will continue to be hospitalized daily, some of whom may benefit from lenzilumab.

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."

Bristol Myers Squibb Presents New Data at Digestive Disease Week® on Zeposia (ozanimod) Highlighting Clinical Benefits and Safety Profile in Patients with Ulcerative Colitis

Retrieved on: 
Sunday, May 23, 2021

Of these, 80% and 54.6% of patients who received Zeposia and placebo, respectively, completed the study.

Key Points: 
  • Of these, 80% and 54.6% of patients who received Zeposia and placebo, respectively, completed the study.
  • Patients discontinuing treatment due to TEAEs included 3 patients receiving Zeposia and 6 patients receiving placebo; disease relapse (13.5% Zeposia, 33.9% placebo) was the most common reason for discontinuation.
  • Ulcerative colitis has a major impact on patients' health-related quality of life, including physical functioning, social and emotional well-being and ability to work.
  • The European Medicines Agency validated Bristol Myers Squibb\xe2\x80\x99s Marketing Authorization Application for Zeposia for the treatment of adults with moderately to severely active ulcerative colitis in December 2020.

Ferring and Rebiotix Present Landmark Phase 3 Data Demonstrating Superior Efficacy of Investigational RBX2660 Versus Placebo to Reduce Recurrence of C. difficile Infection

Retrieved on: 
Friday, May 21, 2021

RBX2660 demonstrated superior efficacy versus placebo (70.4% and 58.1%, respectively) at 8 weeks post treatment, with a comparable safety profile to placebo.

Key Points: 
  • RBX2660 demonstrated superior efficacy versus placebo (70.4% and 58.1%, respectively) at 8 weeks post treatment, with a comparable safety profile to placebo.
  • In addition to these outcomes, RBX2660 provided a relative reduction of recurrence of 29.4% compared to placebo.
  • The majority of treatment emergent adverse events (TEAEs) for RBX2660 were similar to placebo, and mild to moderate in nature.
  • difficile infection is a global public health threat that requires immediate action to halt the unrelenting cycle of recurrence.

New Study Suggests Visbiome Vet May Support Gastrointestinal Health in Dogs Undergoing Chemotherapy Treatment

Retrieved on: 
Thursday, May 20, 2021

al) suggests that Visbiome Vet probiotic may help mitigate occasional gastrointestinal concerns in dogs undergoing chemotherapy treatment for lymphoma.\nThe study was conducted at Kansas State University.

Key Points: 
  • al) suggests that Visbiome Vet probiotic may help mitigate occasional gastrointestinal concerns in dogs undergoing chemotherapy treatment for lymphoma.\nThe study was conducted at Kansas State University.
  • Ten dogs with multicentric lymphoma were enrolled in this prospective, randomized, placebo-controlled, single-blinded study.
  • Dogs either received an oral probiotic or an oral placebo daily.\nForty percent of dogs had an unbalanced GI microbiome at baseline, and dysbiosis was common in dogs with multicentric lymphoma.\nResults were promising.
  • Not one dog receiving probiotics experienced occasional diarrhea, compared to 4 out of 5 dogs who received the placebo.

Soligenix Receives Japanese Patent for Improved Production of Synthetic Hypericin Composition

Retrieved on: 
Thursday, May 20, 2021

The allowed claims are directed to unique, proprietary methods to produce a novel, highly purified form of synthetic hypericin, and are similar to those previously allowed in the United States (U.S.).

Key Points: 
  • The allowed claims are directed to unique, proprietary methods to produce a novel, highly purified form of synthetic hypericin, and are similar to those previously allowed in the United States (U.S.).
  • "\nCTCLis a class of non-Hodgkin\'s lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system.
  • In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective.
  • In the first double-blind treatment cycle, 116 patients received HyBryte treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions.

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.

Milestone Pharmaceuticals Announces Late-Breaker Oral Presentation of NODE-301 Data at ACC.21

Retrieved on: 
Monday, May 17, 2021

"Etripamil holds the potential to enable patients to treat their episodes in the at-home setting and ultimately take control of their condition.

Key Points: 
  • "Etripamil holds the potential to enable patients to treat their episodes in the at-home setting and ultimately take control of their condition.
  • We remain focused on the execution of our ongoing Phase 3 program and our vision to help patients suffering from episodes of SVT.
  • "Once approved by FDA, etripamil could potentially serve as an effective, meaningful addition to the currently limited PSVT treatment armamentarium.
  • Treatment effectiveness (p=0.001) and global satisfaction (p=0.007) scores were greater in patients treated with etripamil than with placebo.