Placebo

AB Science today announced that results from masitinib study AB12005 in pancreatic cancer have been presented at the 2021 ASCO Annual Meeting

Retrieved on: 
Thursday, June 10, 2021

AB Science SA (Euronext - FR0010557264 - AB) today announced that results from masitinib study AB12005 in pancreatic cancer, have been presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting by the principal coordinating investigator Dr Jol Ezenfis (Head of the Medical Oncology Department the Centre Hospitalier Sud Francilien, France).

Key Points: 
  • AB Science SA (Euronext - FR0010557264 - AB) today announced that results from masitinib study AB12005 in pancreatic cancer, have been presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting by the principal coordinating investigator Dr Jol Ezenfis (Head of the Medical Oncology Department the Centre Hospitalier Sud Francilien, France).
  • For study AB12005, an 18-month overall survival rate of 34% for the masitinib treatment-arm versus 10% for the placebo arm was observed.
  • Study AB12005 was a randomized, placebo-controlled, phase 3 study of masitinib in first-line treatment of unresectable locally advanced or metastatic pancreatic cancer patients with pain at baseline or taking opioids.
  • Masitinib plus gemcitabine as first-line treatment of pancreatic cancer with pain: Results from phase 3 study AB12005.

New Data Analysis Supports GOCOVRI as an Important Treatment for Motor Complications for People With Parkinson’s Disease

Retrieved on: 
Thursday, June 10, 2021

The publication highlights a post-hoc data analysis from two placebo-controlled Phase 3 clinical trials, including a total of 196 patients.

Key Points: 
  • The publication highlights a post-hoc data analysis from two placebo-controlled Phase 3 clinical trials, including a total of 196 patients.
  • Results from the analysis were driven primarily by improvements in motor activities important to patients such as freezing, tremor, and getting out of bed/car/deep chair.
  • This analysis suggests that GOCOVRI may meaningfully reduce the impact of PD motor symptoms on experiences of daily living, said Adrian Quartel, Chief Medical Officer, Adamas.
  • In this post-hoc analysis, the treatment impact of GOCOVRI on patient-reported motor experiences of daily living was assessed using Part II of the Movement Disorder Society Unified Parkinsons Disease Rating Scale (MDS-UPDRS).

Soligenix Receives Pediatric Investigational Plan Waiver for HyBryte™ in CTCL from the European Medicines Agency

Retrieved on: 
Thursday, June 10, 2021

Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients.

Key Points: 
  • Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients.
  • 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.
  • The third (optional) treatment cycle (Cycle 3) was focused on safety and all patients could elect to receive HyBryte treatment of all their CTCL lesions .

Virios Therapeutics Highlights Safety Data from Phase 2a Fibromyalgia Trial at the International Association for the Study of Pain (IASP) World Congress

Retrieved on: 
Wednesday, June 9, 2021

This result is highlighted in a poster presentation at the International Association for the Study of Pain (IASP) World Congress, being held virtually June 9 - 11, 2021 and June 16 - 18, 2021.

Key Points: 
  • This result is highlighted in a poster presentation at the International Association for the Study of Pain (IASP) World Congress, being held virtually June 9 - 11, 2021 and June 16 - 18, 2021.
  • Our Phase 2a clinical trial data showed that IMC-1 treated patients had higher overall completion rates and lower rates of discontinuation due to adverse events, as compared with placebo-treated patients.
  • In this study, IMC1 demonstrated significant reductions in pain, fatigue, and other important symptoms in patients with FM.
  • Evidence of IMC-1s efficacy on a broad spectrum of FM outcome measures was previously demonstrated in a Phase 2a clinical trial.

FREQUENCY THERAPEUTICS ALERT: Bragar Eagel & Squire, P.C. Announces That a Class Action Lawsuit Has Been Filed Against Frequency Therapeutics, Inc. and Encourages Investors to Contact the Firm

Retrieved on: 
Saturday, June 5, 2021

Investors have until August 2, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

Key Points: 
  • Investors have until August 2, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
  • According to the complaint, Frequency Therapeutics began its Phase 2a trial for FX-322 in October 2019.
  • The trial results failed to live up to the Companys expectations, as they revealed no discernable difference between FX-322 and the placebo.
  • On this news, Frequency Therapeutics shares fell 78% from $36.29 to $7.99, losing approximately $955 in market capitalization.

FDA Approves New Drug Treatment for Chronic Weight Management, First Since 2014

Retrieved on: 
Friday, June 4, 2021

This under-the-skin injection is the first approved drug for chronic weight management in adults with general obesity or overweight since 2014.

Key Points: 
  • This under-the-skin injection is the first approved drug for chronic weight management in adults with general obesity or overweight since 2014.
  • "FDA remains committed to facilitating the development and approval of additional safe and effective therapies for adults with obesity or overweight."
  • Individuals who received Wegovy lost an average of 12.4% of their initial body weight compared to individuals who received placebo.
  • In this trial, individuals who received Wegovy lost 6.2% of their initial body weight compared to those who received placebo.

BeiGene Presents Clinical Data from Two Phase 2 Trials of Pamiparib at the 2021 ASCO Annual Meeting

Retrieved on: 
Friday, June 4, 2021

At the data cutoff on December 7, 2020, median follow-up time was 8.0 months (pamiparib arm, 7.9 months; placebo arm, 8.0 months).

Key Points: 
  • At the data cutoff on December 7, 2020, median follow-up time was 8.0 months (pamiparib arm, 7.9 months; placebo arm, 8.0 months).
  • To date, more than 1,200 patients have been enrolled in clinical trials of pamiparib.
  • Full approval for this indication is contingent upon results from ongoing corroborative trials confirming the clinical benefit of pamiparib in this population.
  • Our expansive portfolio is directed by a predominantly internalized clinical development team supporting trials in more than 40 countries.

4D pharma Completes Enrollment of Part A of the Phase I/II Trial of MRx-4DP0004 for the Treatment of Asthma and Provides Program Update

Retrieved on: 
Friday, June 4, 2021

Following the completion of enrollment of Part A, 4D pharma expects to announce topline results from these patients in the second half of 2021.

Key Points: 
  • Following the completion of enrollment of Part A, 4D pharma expects to announce topline results from these patients in the second half of 2021.
  • 4D pharma has demonstrated MRx-4DP0004s ability to reduce airway inflammation in a pre-clinical model of severe asthma.
  • The completion of enrollment in Part A of 4D pharmas asthma study is an important milestone for this program.
  • The first-in-human Phase I/II trial is a two part, multi-center, randomized, double-blind, placebo-controlled trial of MRx-4DP0004 in patients taking long-term medication for asthma.

COMPASS Pathways and Kings College London publish cognition results from COMP360 psilocybin study in healthy volunteers

Retrieved on: 
Thursday, June 3, 2021

The study looked at the effects of two doses of COMP360 psilocybin (10mg and 25mg) compared with placebo in 89 healthy male and female adult volunteers.

Key Points: 
  • The study looked at the effects of two doses of COMP360 psilocybin (10mg and 25mg) compared with placebo in 89 healthy male and female adult volunteers.
  • The participants were randomised in a 1:1:1 ratio to receive 10mg COMP360 (n=30), 25mg COMP360 (n=30), or placebo (n=29).
  • The results are encouraging and we are looking forward to reporting data from our phase IIb trial of COMP360 psilocybin therapy for treatment-resistant depression (TRD) later this year.
  • Dr Rucker said: This study, the largest randomised placebo-controlled trial of psilocybin to date, found that COMP360 psilocybin had no clinically-relevant negative effect on cognitive function.

Arrowhead Pharmaceuticals Initiates Phase 2b Study of Investigational ARO-APOC3 for Treatment of Severe Hypertriglyceridemia

Retrieved on: 
Thursday, June 3, 2021

Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it has dosed the first patient in AROAPOC3-2001, a Phase 2b clinical study of ARO-APOC3, the companys investigational RNA interference (RNAi) therapeutic being developed as a treatment for patients with severe hypertriglyceridemia (SHTG).

Key Points: 
  • Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it has dosed the first patient in AROAPOC3-2001, a Phase 2b clinical study of ARO-APOC3, the companys investigational RNA interference (RNAi) therapeutic being developed as a treatment for patients with severe hypertriglyceridemia (SHTG).
  • Arrowhead also intends to initiate a Phase 2b study and a Phase 3 study of ARO-APOC3 in two additional patient populations in 2021.
  • We believe there remains a significant need for new therapies that can substantially lower and sustain triglyceride levels in patients with severe hypertriglyceridemia.
  • AROAPOC3-2001 is a double-blind, placebo-controlled Phase 2b study to evaluate the efficacy and safety of ARO-APOC3 in adults with SHTG.