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AstraZeneca's Saphnelo Enters Phase III Trials for Cutaneous Lupus and Inflammatory Myopathies

  • AstraZeneca has initiated two new Phase III trials, LAVENDER and JASMINE, to evaluate Saphnelo (anifrolumab) in cutaneous lupus erythematosus (CLE) and idiopathic inflammatory myopathies (IIM), respectively.
  • The LAVENDER trial will assess Saphnelo's efficacy in reducing skin disease in approximately 460 adults with chronic and/or cutaneous lupus erythematosus.
  • The JASMINE trial will evaluate the efficacy and safety of subcutaneous Saphnelo in about 240 adults with moderate to severe idiopathic inflammatory myopathies.
  • These trials reflect AstraZeneca's focus on immune-mediated diseases and the potential of Saphnelo, a type I interferon receptor antagonist, in conditions with high unmet needs.

Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis

NCT05138133RecruitingPhase 3
AstraZeneca
Posted 2/15/2022

A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)

NCT06455449RecruitingPhase 3
AstraZeneca
Posted 6/20/2024

A 2-stage, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus

NCT06015737RecruitingPhase 3
AstraZeneca
Posted 6/29/2024

Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)

NCT05925803RecruitingPhase 3
AstraZeneca
Posted 11/8/2023

Multinational Pharmacogenomics Study in Africa Aims to Optimize Treatment Outcomes

  • Professor Collen Masimirembwa leads a multinational study across Nigeria, Kenya, Zimbabwe, and South Africa to explore how genes affect medication response.
  • The iPROTECTA protocol will test the clinical benefit of pharmacogenomics, using the GenoPharm genetic test to optimize treatments for sickle cell disease and gastro-intestinal tumors.
  • The study aims to address the gap in pharmacogenomics research and clinical implementation in the Global South, potentially improving treatment outcomes.
  • The African Institute of Biomedical Science and Technology (AiBST) contributes to genomics training and research, fostering drug development by African scientists.

Edgewise Therapeutics' EDG-7500 Shows Positive Results in Hypertrophic Cardiomyopathy Trials

  • Edgewise Therapeutics announced positive top-line data for EDG-7500 in Phase 1 and Phase 2 trials, demonstrating its potential in treating obstructive hypertrophic cardiomyopathy (HCM).
  • The Phase 1 trial showed EDG-7500 was well-tolerated in healthy subjects, with no clinically meaningful changes in left ventricle ejection fraction (LVEF).
  • In the Phase 2 CIRRUS-HCM trial, single doses of EDG-7500 led to significant reductions in left ventricular outflow tract (LVOT) gradient without impacting LVEF.
  • A 64% mean reduction in NT-proBNP, a key heart failure biomarker, was observed, highlighting EDG-7500's potential in diastolic dysfunction diseases.

A Study of EDG-7500 in Adults With Hypertrophic Cardiomyopathy (CIRRUS-HCM)

NCT06347159RecruitingPhase 2
Edgewise Therapeutics, Inc.
Posted 4/11/2024

Biosyngen Presents SUPER-T Cell Technology at ESMO 2024 for Enhanced CAR-T Therapy Safety and Efficacy

  • Biosyngen presented its SUPER-T cell technology at ESMO 2024, featuring conditional activation and armor enhancement for safer, more effective CAR-T cell therapies.
  • The SUPER-T platform includes BTRP003L, activated in hypoxic tumor microenvironments, and BTRP011L, with enhanced efficacy and in vivo persistence at lower doses.
  • Preclinical toxicology studies of SUPER-T platform showed no significant adverse effects, demonstrating robust safety in initial assessments.
  • Biosyngen's lead product, BRG01, is in a pivotal Phase II trial for solid tumors, with Phase I trials for BST02 and BRL03 expected to complete later this year.

Longboard Pharmaceuticals Launches Phase 3 Trial of Bexicaserin for Dravet Syndrome

  • Longboard Pharmaceuticals has initiated a global Phase 3 trial, DEEp SEA, to evaluate bexicaserin for treating seizures associated with Dravet syndrome.
  • The study will enroll approximately 160 participants aged 2 to 65 and assess the efficacy and safety of bexicaserin over a 12-week maintenance period.
  • Bexicaserin has received Orphan Drug and Rare Pediatric Disease designations from the FDA, providing incentives for its development as a Dravet syndrome treatment.
  • Previous Phase 1b/2a trial data showed significant reductions in seizure frequency among Dravet syndrome patients treated with bexicaserin.

Open-label, Long-term Safety Study of LP352 in Subjects With Developmental and Epileptic Encephalopathy

NCT05626634CompletedPhase 2
Longboard Pharmaceuticals
Posted 11/8/2022

Study to Investigate LP352 in Subjects With Developmental and Epileptic Encephalopathies

NCT05364021CompletedPhase 1
Longboard Pharmaceuticals
Posted 3/3/2022

ORIC Pharmaceuticals Maintains Buy Rating Amidst Competitive Landscape

H.C. Wainwright reaffirms its Buy rating and $21 price target for ORIC Pharmaceuticals, following a review of competitor Ipsen's trial results at the ESMO 2024 conference. Despite Ipsen's positive outcomes, ORIC's potential in prostate cancer treatments and its financial stability keep investor confidence high.

Novel AR Degraders and Emerging Therapies Show Promise in Advanced Prostate Cancer Treatment

  • Cross-resistance between androgen receptor pathway inhibitors and their earlier use in treatment have created significant limitations for metastatic castration-resistant prostate cancer patients, highlighting an urgent need for new therapeutic options.
  • AR degraders are showing encouraging results with meaningful PSA responses and manageable toxicity profiles, offering potential new oral treatment options for mCRPC patients.
  • Radioligand therapy advancements, including lutetium Lu 177 vipivotide tetraxetan and emerging alpha emitters, are expanding treatment possibilities with better tolerability compared to chemotherapy.

Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer

NCT03511664CompletedPhase 3
Endocyte
Posted 5/29/2018

Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment

NCT04647526Active, Not RecruitingPhase 3
POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company
Posted 2/25/2021

GSK's Arexvy Shows Sustained RSV Protection Over Three Seasons; Co-administration with Shingrix Yields Positive Results

  • GSK's Arexvy vaccine demonstrates 62.9% cumulative efficacy against RSV-related lower respiratory tract disease (LRTD) over three seasons in adults aged 60 and older.
  • A single dose of Arexvy showed 67.4% efficacy against severe RSV-LRTD across three seasons, with 48% efficacy in the third season alone.
  • Co-administration of Arexvy with Shingrix, GSK's shingles vaccine, showed non-inferior immune response compared to separate administrations in a Phase 3 trial.
  • The co-administered vaccines displayed adequate tolerability and acceptable safety profiles, potentially reducing healthcare visits for adult immunization.

A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and Above

NCT05590403CompletedPhase 3
GlaxoSmithKline
Posted 10/28/2022

Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above

NCT04886596CompletedPhase 3
GlaxoSmithKline
Posted 5/25/2021

Takeda Presents New Data on TAK-861 Orexin Agonist for Narcolepsy at Sleep Europe 2024

  • Takeda presented Phase 2b trial data of TAK-861, an oral orexin receptor 2 selective-agonist, demonstrating improvements in daily functioning, cognition, and sleep quality in narcolepsy type 1 (NT1).
  • An interim analysis of a long-term extension study of TAK-861 showed sustained efficacy and safety, with some patients reaching one year of treatment.
  • Based on positive Phase 2b results, Takeda has initiated a global Phase 3 trial (FirstLight Study) to further evaluate the efficacy and safety of TAK-861 in adults with NT1.
  • Takeda is also progressing TAK-360, another orexin agonist, for narcolepsy type 2 and idiopathic hypersomnia, highlighting its commitment to addressing various sleep-wake disorders.

Kiromic BioPharma's Deltacel Shows Promise in NSCLC Trial, Moves to Dose Expansion

  • Kiromic BioPharma's Deltacel (KB-GDT-01) receives unanimous approval from the Safety Monitoring Committee to advance into the dose expansion phase of its Phase 1/2 trial for NSCLC.
  • Interim data from the Deltacel-01 trial shows a median progression-free survival of 6 months and tumor reduction in some patients with advanced NSCLC.
  • The first patient treated in the Deltacel-01 trial exhibited a 27% reduction in tumor size at 10 months, with no reported adverse events, indicating durable clinical benefit.
  • Kiromic has activated multiple clinical sites, including the University of Arizona Cancer Center, to enhance patient enrollment in the Deltacel-01 trial's expansion phase.

Safety Study for a Gamma Delta T Cell Product Used with Low Dose Radiotherapy in Patients with Locally Advanced or Metastatic NSCLC or Solid Tumors with Bone Metastases

NCT06069570RecruitingPhase 1
Kiromic BioPharma Inc.
Posted 11/7/2023

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