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Clinical Trial News

Johnson & Johnson Seeks FDA Approval for Tremfya to Treat Pediatric Psoriasis and Arthritis

  • Johnson & Johnson has submitted sBLAs to the FDA for Tremfya (guselkumab) to treat moderate-to-severe plaque psoriasis in children aged 6 and older.
  • The submission also seeks approval for Tremfya to treat active juvenile psoriatic arthritis in children aged 5 and older.
  • The sBLAs are based on data from the Phase 3 PROTOSTAR study and pharmacokinetic data from adult studies VOYAGE 1 and 2, and DISCOVER 1 and 2.
  • Tremfya, an IL-23 inhibitor, is already approved for adults with plaque psoriasis, psoriatic arthritis, and ulcerative colitis.

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants

NCT03451851Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 7/11/2018

Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis

NCT06039189CompletedPhase 3
Janssen Research & Development, LLC
Posted 8/24/2023

A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis

NCT03158285CompletedPhase 3
Janssen Research & Development, LLC
Posted 7/12/2017

A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease

NCT05197049Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 1/19/2022

A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

NCT03466411Active, Not RecruitingPhase 2
Janssen Research & Development, LLC
Posted 4/13/2018

A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

NCT04033445Active, Not RecruitingPhase 2
Janssen Research & Development, LLC
Posted 9/26/2019

A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti -Tumor Necrosis Factor (TNF) Alpha Agent(s)

NCT03162796CompletedPhase 3
Janssen Research & Development, LLC
Posted 8/24/2017

A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

NCT05528510Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 9/13/2022

A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and Retreatment

NCT02207244CompletedPhase 3
Janssen Research & Development, LLC
Posted 11/3/2014

A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis

NCT02207231CompletedPhase 3
Janssen Research & Development, LLC
Posted 11/26/2014

Sanofi's Acne Vaccine to Undergo Clinical Trials in Singapore

  • Sanofi is collaborating with A*Star and the National Skin Centre (NSC) in Singapore to conduct early-stage clinical trials for its novel acne vaccine.
  • The trial, set to begin in 2025, will involve approximately 200 participants with mild acne to assess the vaccine's effectiveness.
  • A separate trial for severe acne is already underway in the United States, with the vaccine aiming to reduce acne severity and potentially offer a cure.
  • The partnership will also focus on broader research into Asian-specific skin conditions, leveraging Singapore's diverse population.

Mursla Bio's EvoLiver Test Shows Promise in Early Liver Cancer Detection

  • Mursla Bio's EvoLiver test, a dynamic biopsy-based blood test, demonstrates high sensitivity and specificity in detecting early-stage hepatocellular carcinoma (HCC).
  • The multi-center clinical study (MEV01) showed EvoLiver achieved 86% sensitivity and 88% specificity, surpassing existing surveillance methods like ultrasound and alpha-fetoprotein testing.
  • EvoLiver isolates hepatocyte extracellular vesicles (h-EVs) from blood samples to validate a novel HCC biomarker signature, potentially improving patient outcomes through earlier detection.
  • The company plans to publish final MEV01 results in 2025, offer the test as a Laboratory Developed Test (LDT) in the US, and conduct a larger study for FDA approval.

Cassava Sciences to Provide Corporate Update on Alzheimer's Drug Simufilam

  • Cassava Sciences will host a conference call and webcast on November 25th to provide a corporate update.
  • The update will likely cover the ongoing Phase 3 clinical trials of Simufilam, an investigational drug for Alzheimer's disease.
  • Simufilam is an oral small molecule that targets filamin A protein, with Cassava Sciences holding worldwide rights.
  • The webcast replay will be available on the company's website for 90 days following the live event.

Applied Therapeutics Awaits FDA Decision on Govorestat for Galactosemia

  • Applied Therapeutics is seeking FDA approval for govorestat, a novel aldose reductase inhibitor, for the treatment of galactosemia, a rare metabolic disorder.
  • Govorestat aims to reduce the production of galactitol, a toxic metabolite that causes neurological damage in galactosemia patients, with no currently approved therapies.
  • Clinical data from Phase I/II and Phase III trials suggest govorestat can reduce galactitol levels and improve clinical outcomes in both adult and pediatric patients.
  • The FDA's decision on govorestat is anticipated by November 28, marking a potential first-ever approved treatment for this rare condition.

Sage Therapeutics' Dalzanemdor Fails in Huntington's Disease Trial, Pipeline Thins

  • Sage Therapeutics' dalzanemdor failed in the Phase II DIMENSION trial for Huntington's disease, leading to the discontinuation of its development.
  • This setback follows previous failures of dalzanemdor in Parkinson's and Alzheimer's, further impacting Sage's clinical pipeline.
  • Sage is now heavily reliant on Zurzuvae for postpartum depression, with strategic reorganizations aimed at supporting its commercial launch.
  • Analysts express concerns about Sage's path to profitability despite cost-cutting measures and the initial success of Zurzuvae.

FDA Approves BridgeBio's Attruby for Transthyretin Amyloid Cardiomyopathy

• The FDA has approved BridgeBio's Attruby, an oral medication, for treating transthyretin amyloid cardiomyopathy (ATTR-CM), a rare and severe heart disorder. • ATTR-CM is characterized by the accumulation of defective transthyretin proteins in the heart, leading to significant health risks for affected individuals. • Attruby provides a new therapeutic option for adult patients with ATTR-CM, potentially improving outcomes in a treatment landscape previously dominated by Pfizer's Vyndaqel. • The approval marks a significant advancement for BridgeBio, offering hope to patients with this debilitating condition and expanding treatment accessibility.

Cardiol Therapeutics Advances CardiolRx™ for Recurrent Pericarditis to Phase 3 Trial

  • Cardiol Therapeutics is advancing its lead drug, CardiolRx™, to a Phase 3 clinical trial (MAVERIC) for patients with recurrent pericarditis at high risk of recurrence.
  • CardiolRx™ is uniquely positioned to address critical gaps in current treatment options for recurrent pericarditis, potentially offering a safer, more cost-effective, and disease-modifying approach.
  • Phase 2 trial results presented at the American Heart Association showed sustained pain reduction and decreased inflammation markers with CardiolRx™.
  • The FDA has granted Orphan Drug Designation to CardiolRx™ for the treatment of pericarditis, which includes recurrent pericarditis, potentially accelerating its path to market.

Impact of CardiolRx on Myocardial Recovery in Patients With Acute Myocarditis

NCT05180240CompletedPhase 2
Cardiol Therapeutics Inc.
Posted 6/22/2022

Impact of CardiolRxTM on Recurrent Pericarditis (MAvERIC-Pilot)

NCT05494788CompletedPhase 2
Cardiol Therapeutics Inc.
Posted 11/30/2022

Novotech Report Highlights Trends in Global Vaccine Clinical Trials

  • Novotech has released an in-depth whitepaper analyzing the global vaccine clinical trial landscape, offering strategic insights for biotech and pharmaceutical stakeholders.
  • The report highlights the expansion of mRNA platforms and innovative delivery methods, as well as efforts to ensure equitable vaccine access.
  • Key trends include adaptive trial designs, personalized vaccine trials, and a growing role for the Asia-Pacific region in therapeutic vaccine development.
  • The whitepaper also provides insights into venture funding, M&A activity, and streamlined regulatory processes aimed at expediting vaccine approvals.

iiCON-Supported Phase II Trial to Advance Novel Pneumococcal Vaccine, PnuBioVax

  • A new £3.2 million Medical Research Council-funded trial will advance the development of PnuBioVax, a novel vaccine against pneumococcal disease.
  • The phase II study will assess PnuBioVax's ability to prevent pneumococcal carriage in healthy adults via a controlled human infection model (CHIM) trial in Malawi.
  • PnuBioVax, developed by ImmBio, targets serotype 3 pneumococcus (SPN3), a dominant strain with increasing antimicrobial resistance, especially in low- and middle-income countries.
  • The trial aims to establish a low-cost vaccine that can be manufactured and distributed in Africa, potentially blocking community transmission of multiple serotypes.

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