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Biosplice Publishes Phase 2B Lorecivivint Analysis Showing Clinically Meaningful Benefits to Knee Osteoarthritis Patients

Retrieved on: 
Thursday, July 22, 2021

SAN DIEGO, July 22, 2021 (GLOBE NEWSWIRE) -- Biosplice Therapeutics, Inc. (“Biosplice”), a clinical-stage biotechnology company pioneering therapeutics based on alternative pre-mRNA splicing for major diseases, announced today the publication of a post-hoc analysis of its successful Phase 2b knee osteoarthritis clinical trial in Rheumatology and Therapy. Biosplice showed that study subjects dosed with 0.07 mg lorecivivint were over two times more likely to meet the criteria for OMERACT-OARSI Strict Response, a measure that includes 50% improvement in pain or function, than those on placebo at 12 weeks. Further, this response was maintained until the end of the study at 24 weeks.

Key Points: 
  • The importance of this analysis is that we are able to highlight the magnitude of the superiority of lorecivivint treatment for knee OA pain and function over placebo, said Biosplice Chief Medical Officer, Yusuf Yazici, MD.
  • While our successful Phase 2b study already demonstrated that lorecivivint significantly outperformed placebo in daily pain measurements out to six months, this further analysis sheds new light on the high potential of lorecivivint to relieve osteoarthritic patient suffering.
  • These confirmatory Phase 3 clinical trials ( NCT04385303 and NCT03928184 ) are further evaluating the impact of lorecivivint on knee osteoarthritis pain, function, and structure and have been modeled after Biosplices successful Phase 2b trial.
  • As reported earlier in the primary analysis of the Phase 2b study results, safety findings were similar between lorecivivint and placebo.

Merck Presents New Data from Ongoing Phase 2a Clinical Trial Evaluating the Safety, Tolerability and Pharmacokinetics of Investigational, Once-Monthly, Oral Islatravir for HIV-1 Prevention at IAS 2021

Retrieved on: 
Tuesday, July 20, 2021

After 24 weeks, once-monthly oral islatravir was generally well tolerated versus placebo.

Key Points: 
  • After 24 weeks, once-monthly oral islatravir was generally well tolerated versus placebo.
  • Most adverse events (AEs) were mild and there were no serious drug-related AEs in people who received islatravir.
  • Unblinded safety data showed that both doses of islatravir were generally well tolerated versus placebo over 24 weeks and most AEs were mild (73.5%).
  • The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Alexion Announces Positive Topline Results from Phase 3 Study of ULTOMIRIS® (ravulizumab-cwvz) in Adults with Generalized Myasthenia Gravis (gMG)

Retrieved on: 
Thursday, July 15, 2021

Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced positive topline results from a Phase 3 study evaluating the safety and efficacy of ULTOMIRIS (ravulizumab-cwvz) in adults with generalized myasthenia gravis (gMG).

Key Points: 
  • Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced positive topline results from a Phase 3 study evaluating the safety and efficacy of ULTOMIRIS (ravulizumab-cwvz) in adults with generalized myasthenia gravis (gMG).
  • Based on these results, Alexion plans to make regulatory filings in the U.S., European Union and Japan in late 2021/early 2022.
  • These Phase 3 ULTOMIRIS results reinforce the critical role complement inhibition plays in treating gMG.
  • The most frequently observed adverse events were headache (ULTOMIRIS: 18.6%; placebo: 25.8%), diarrhea (ULTOMIRIS: 15.1%; placebo: 12.4%) and nausea (ULTOMIRIS: 10.5%; placebo: 10.1%).

Madrigal Pharmaceuticals Offers Patients Resmetirom in a Planned Open Label Active Treatment Extension of the Phase 3 MAESTRO-NAFLD-1 Clinical Study

Retrieved on: 
Tuesday, July 13, 2021

CONSHOHOCKEN, Pa., July 13, 2021 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) announced today its first patient dosed in a planned 52-week open label active treatment extension study of MAESTRO-NAFLD-1, named MAESTRO-NAFLD-1-Open Label Extension (OLE) (NCT04951219).

Key Points: 
  • CONSHOHOCKEN, Pa., July 13, 2021 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) announced today its first patient dosed in a planned 52-week open label active treatment extension study of MAESTRO-NAFLD-1, named MAESTRO-NAFLD-1-Open Label Extension (OLE) (NCT04951219).
  • MAESTRO-NAFLD-1 is an ongoing 52-week ~1200 patient Phase 3 non-invasive, multi-center, double-blind, randomized, placebo-controlled study of resmetirom in patients with non-alcoholic fatty liver disease (NAFLD), presumed NASH.
  • MAESTRO-NAFLD-OLE allows patients who complete MAESTRO-NAFLD-1 to consent to 52 weeks of active treatment with resmetirom, making this treatment available to patients who were assigned to placebo in the main study and allowing patients who were on resmetirom to continue treatment with the drug.
  • Patients and physicians participating in MAESTRO-NAFLD-1 are enthusiastic about the opportunity to continue active treatment with resmetirom in the extension study, stated Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal.

Aimmune to Present New Two-Year Treatment Satisfaction Data From Patients With Peanut Allergy at EAACI Hybrid Annual Congress 2021

Retrieved on: 
Friday, July 9, 2021

The company will share updated treatment satisfaction data evaluated in its Phase 3, randomised, double-blind, placebo-controlled trial, PALISADE, and open-label follow-on trial, ARC004.

Key Points: 
  • The company will share updated treatment satisfaction data evaluated in its Phase 3, randomised, double-blind, placebo-controlled trial, PALISADE, and open-label follow-on trial, ARC004.
  • Patient-reported treatment satisfaction was evaluated over two years following daily treatment with PALFORZIA in a clinical trial setting using the Treatment Satisfaction Questionnaire for Medication (TSQM-9).
  • Peanut allergic participants reported overall satisfaction with the effectiveness and convenience items, as well as the medications ability to treat their condition.
  • Additional data to be presented at EAACI include an update on the ongoing Phase 3 ARC008 open-label study which is looks at longer-term safety in patients.

Athira Pharma Announces Initiation of Open Label Extension Study for LIFT-AD and ACT-AD Clinical Trials of ATH-1017 for Alzheimer’s Disease

Retrieved on: 
Tuesday, July 6, 2021

The data we will continue to collect in this open label extension could help us to better understand the long-term safety and efficacy profile of ATH-1017 and could help Athira best design future clinical trials of ATH-1017.

Key Points: 
  • The data we will continue to collect in this open label extension could help us to better understand the long-term safety and efficacy profile of ATH-1017 and could help Athira best design future clinical trials of ATH-1017.
  • The randomized, double-blind, placebo-controlled trials are evaluating the safety and efficacy of ATH-1017 in mild-to-moderate Alzheimers disease.
  • Patients in both trials are being evaluated for improvement in cognition, global and functional assessments comparing treatment arms to placebo.
  • In addition to Alzheimers disease, ATH-1017 is designed to address the broader dementia population, including Parkinsons disease dementia.

Therapeutic Solutions International Demonstrates Potent Brain Protective Activity of JadiCells in Animal Model of Post-Covid-19 Neurological Damage

Retrieved on: 
Wednesday, June 30, 2021

The experiments are part of a series of ongoing work in development of the JadiCells as a treatment for post-COVID brain damage.

Key Points: 
  • The experiments are part of a series of ongoing work in development of the JadiCells as a treatment for post-COVID brain damage.
  • In a double blind, placebo controlled clinical trial, the JadiCell was used to treat 12 patients, while 12 received placebo.
  • "At Therapeutic Solutions International we are committed to conquering the invisible enemy called COVID-19.
  • Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases.

Retrotope Announces Initiation of Phase 2 Study of RT001 in Patients with Progressive Supranuclear Palsy (PSP)

Retrieved on: 
Wednesday, June 30, 2021

The Phase 2 trial is a randomized, double-blind, placebo-controlled study evaluating the efficacy, long-term safety and tolerability of RT001 in patients with PSP.

Key Points: 
  • The Phase 2 trial is a randomized, double-blind, placebo-controlled study evaluating the efficacy, long-term safety and tolerability of RT001 in patients with PSP.
  • Study investigators will enroll and randomize approximately 40 patients to receive either RT001 or placebo daily for 48 weeks.
  • Additionally, study investigators will also evaluate the efficacy of RT001 using a second PSP rating scale suggested by the United States Food and Drug Administration (FDA).
  • The study also includes several secondary and exploratory endpoints intended to further elucidate the efficacy and safety profile of RT001 as compared to placebo.

Dapagliflozin is Well Tolerated in Hospitalized COVID-19 Patients

Retrieved on: 
Sunday, June 27, 2021

Patients received dapagliflozin or placebo for 30 days in addition to the standard of care for COVID-19 in the participating hospital.

Key Points: 
  • Patients received dapagliflozin or placebo for 30 days in addition to the standard of care for COVID-19 in the participating hospital.
  • Numerically fewer patients treated with dapagliflozin experienced organ failure or death (11.2% versus 13.8% with placebo, respectively), although this difference was not statistically significant.
  • Dapagliflozin was well tolerated, with numerically fewer serious adverse events than placebo, and these findings were also consistent in patients with and without type 2 diabetes.
  • The authors state that future trials are needed to further evaluate possible effects of dapagliflozin on the risk of organ failure or death in patients hospitalized with COVID-19.

Terns Announces Initiation of Patient Dosing in AVIATION Phase 1b NASH Clinical Trial of VAP-1 Inhibitor TERN-201

Retrieved on: 
Thursday, June 24, 2021

The primary objective of the AVIATION Trial is to evaluate the safety and tolerability of TERN-201 versus placebo when given for 12 weeks in patients with NASH.

Key Points: 
  • The primary objective of the AVIATION Trial is to evaluate the safety and tolerability of TERN-201 versus placebo when given for 12 weeks in patients with NASH.
  • Each part of the AVIATION Trial is planned to include approximately 20 patients receiving each of the designated doses of TERN-201 and approximately 10 patients receiving placebo.
  • The clinical trial will also explore the effects of TERN-201 on NASH imaging biomarkers (such as cT1) and NASH blood biomarkers (such as CK-18).
  • Preliminary topline 12-week data from Part 1 and Part 2 of the AVIATION Trial are expected in 1H 2022 and 2H 2022, respectively.