MedPath

Clinical Trial News

Healthcare Discrimination Study Reveals Multiple Barriers for Sickle Cell Disease Patients

  • A new qualitative study involving 18 participants with sickle cell disease reveals widespread discrimination in healthcare settings based on race, pain management needs, and disease-related stigma.
  • Patients report varying levels of trust with healthcare providers, with positive relationships built on open communication and proper pain acknowledgment, while negative experiences stem from feeling disrespected or unheard.
  • Researchers recommend enhanced provider education, improved emergency department protocols, and better patient-centered care approaches to address discrimination and improve treatment outcomes.

BioVersys Secures $6M Investment to Advance BV100 Clinical Program in China

  • BioVersys has received a $6 million investment from GIBF2 to support the clinical development of BV100, an antibacterial drug, in China.
  • A Phase 1 study of BV100 in healthy Chinese volunteers is planned for early 2025 to assess safety and pharmacokinetics.
  • The investment aims to address the rising rates of Carbapenem-Resistant Acinetobacter baumannii (CRAB) infections in China.
  • BioVersys plans to integrate Chinese patients into its global Phase 3 registrational study for BV100 following the Phase 1 trial.

Dupixent Approved by FDA as First Biologic for COPD with Eosinophilic Phenotype

  • The FDA has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype.
  • Approval was based on Phase 3 trials showing significant reductions in COPD exacerbations and improvements in lung function and quality of life compared to placebo.
  • Dupixent targets the IL-4 and IL-13 pathways, offering a novel approach for COPD patients with type 2 inflammation and elevated blood eosinophils.
  • Sanofi and Regeneron's Dupixent is now the first and only approved add-on biologic medicine for inadequately controlled COPD in the US.

Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation

NCT03930732CompletedPhase 3
Sanofi
Posted 4/15/2019

Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate to Severe COPD With Type 2 Inflammation

NCT04456673CompletedPhase 3
Sanofi
Posted 7/6/2020

Study Links Anti-tTG and EMA Antibodies to Fibromyalgia Risk in Celiac Disease Patients

  • A cross-sectional study reveals patients with celiac disease who test positive for anti-tTG and anti-EMA antibodies show significantly higher rates of fibromyalgia (P = 0.04).
  • Research conducted at Bezmialem Vakif University demonstrates overlapping symptoms between celiac disease and fibromyalgia, suggesting a potential autoimmune inflammatory connection.
  • Investigators emphasize the importance of screening for fibromyalgia in celiac disease patients with extraintestinal manifestations to improve treatment outcomes.

Piflufolastat (18F) Now Available in Spain for Prostate Cancer Detection

  • Piflufolastat (18F), sold as PYLCLARI, has been launched in Spain for detecting prostate-specific membrane antigen (PSMA)-positive lesions via PET scans in prostate cancer patients.
  • This diagnostic tracer is now available in seven European countries, including Austria, France, Germany, Greece, Italy, the Netherlands and Spain, following its EU marketing authorization in July 2023.
  • Clinical trials, including OSPREY and CONDOR, have demonstrated piflufolastat (18F)'s safety and efficacy in primary staging and recurrence detection of prostate cancer, influencing patient management.
  • Piflufolastat (18F) targets PSMA, a protein found on prostate cancer cells, allowing for enhanced PET imaging and improved localization of the disease.

Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer

NCT03739684CompletedPhase 3
Progenics Pharmaceuticals, Inc.
Posted 11/27/2018

Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer

NCT02981368CompletedPhase 2
Progenics Pharmaceuticals, Inc.
Posted 11/1/2016

Centessa's ORX750 Advances to Phase 2 for Narcolepsy and Idiopathic Hypersomnia After Promising Phase 1 Results

  • Centessa Pharmaceuticals' ORX750, an orexin receptor 2 (OX2R) agonist, demonstrated significant improvements in wakefulness in sleep-deprived healthy volunteers.
  • The 2.5 mg dose of ORX750 restored normal wakefulness, achieving a mean sleep latency of 32 minutes compared to 17 minutes with placebo.
  • ORX750 exhibited a favorable safety profile, with mild and transient adverse events and no significant on-target effects observed.
  • Based on these positive Phase 1 results, Centessa plans to initiate Phase 2 trials in patients with narcolepsy types 1 and 2, and idiopathic hypersomnia in late 2024.

A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2

NCT06555783RecruitingPhase 2
Alkermes, Inc.
Posted 7/26/2024

Amycretin Shows Promising Weight Loss Results in Phase 1 Trial

  • A Phase 1 study of oral amycretin, a novel amylin and GLP-1 receptor co-agonist, demonstrates statistically significant weight loss compared to placebo over 12 weeks.
  • The study reports that amycretin was associated with mild to moderate gastrointestinal side effects, but was generally well-tolerated.
  • Experts emphasize that larger trials are needed to assess long-term efficacy, safety, and impact on disease outcomes compared to existing injectable treatments.
  • Oral medications like amycretin could increase treatment options and potentially lower costs, improving access for individuals with obesity.

Study Reveals Significant Understaging in Early-Stage Pancreatic Cancer Diagnosis

  • A comprehensive analysis of 24,260 pancreatic cancer patients shows that 78.4% of stage I and 29.2% of stage II PDAC cases were upstaged following histopathological examination.
  • Research from Cedars-Sinai demonstrates that missed lymph node involvement is likely the primary cause of clinical understaging, with most stage I patients being upstaged to stage IIB.
  • The study found that neoadjuvant therapy followed by surgical resection resulted in lower upstaging rates compared to upfront surgical resection, suggesting treatment delay does not contribute to disease progression.

Roche Unfazed by Side Effects in Early Obesity Drug Trial, Eyes 'Best-in-Class' Potential

  • Roche remains confident in its obesity drug candidates despite initial concerns over side effects observed in a small study of CT-388, a weight-loss shot.
  • The company emphasizes that no patients discontinued treatment due to side effects, which included nausea, vomiting, and diarrhea.
  • Roche is optimistic about CT-966, an oral weight-loss drug, suggesting it has the potential to be a 'best-in-class' treatment option.
  • The pharmaceutical giant is actively seeking partnerships in antibody-drug conjugates to diversify its oncology portfolio.

Liraglutide (Saxenda) Shows Promise for Weight Loss in Children Aged 6-11

  • A Phase III trial of liraglutide (Saxenda) demonstrated a significant reduction in BMI in children aged 6-11 with obesity, compared to placebo.
  • The study, presented at EASD 2024, showed a 5.8% mean reduction in BMI in the liraglutide group versus a 1.6% increase in the placebo group.
  • Novo Nordisk plans to seek regulatory approval to expand the label for Saxenda to include children older than 6 years, potentially offering a new treatment option for this age group.
  • While generally safe, liraglutide was associated with gastrointestinal side effects, and BMI tended to increase again after stopping the medication.

SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity

NCT04775082Active, Not RecruitingPhase 3
Novo Nordisk A/S
Posted 3/4/2021

Trending News

1

Eli Lilly Acquires Verve Therapeutics for $1.3 Billion to Advance One-Time Gene Editing Treatments for Cardiovascular Disease

5 days ago
2

Eli Lilly Acquires Gene-Editing Biotech Verve Therapeutics for $1.3 Billion to Expand Cholesterol Treatment Pipeline

5 days ago
3

AbbVie's VERONA Trial for High-Risk Myelodysplastic Syndrome Fails to Meet Primary Survival Endpoint

6 days ago
4

FDA Approves CSL's ANDEMBRY for Hereditary Angioedema Prevention with Novel Factor XIIa Targeting

6 days ago
5

FDA Approves Tafasitamab Triple Combination for Relapsed/Refractory Follicular Lymphoma

4 days ago
6

Samsung Biologics Expands Into Preclinical Research with Launch of Samsung Organoids Drug Screening Platform

7 days ago
7

AbbVie's Atogepant Demonstrates Superior Tolerability and Efficacy Over Topiramate in Phase 3 Migraine Prevention Trial

4 days ago
8

D&D Pharmatech's DD01 Shows Rapid Liver Fat Reduction in MASH Phase 2 Trial, Matching Competitor Results in Quarter of the Time

6 days ago
9

Draig Therapeutics Emerges from Stealth with $140M to Advance Novel Neuropsychiatric Therapies

4 days ago
10

NHS App to Feature Clinical Trial Matching System as UK Targets 150-Day Setup Times

7 days ago
Subscribe Icon

Daily Pharma Insights

Get curated, high-impact pharmaceutical news delivered to your inbox every morning.

  • Critical clinical trial updates & results
  • Regulatory approvals & strategic partnerships
  • Market access decisions & commercial developments
© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy