Clinical Trial News
Phase 3 Data Shows Mirikizumab's Efficacy in Crohn's Disease Treatment
Recent Phase 3 data from the VIVID-1 study highlights mirikizumab's effectiveness in treating moderately to severely active Crohn's disease, showing significant clinical remission and endoscopic response rates. The study, presented at Digestive Disease Week 2024, also compared mirikizumab's performance against ustekinumab, revealing its potential advantages, especially in patients with previous biologic failure.
QIAGEN Launches QIAstat-Dx Gastrointestinal Panel 2 in the U.S. for Improved GI Infection Diagnosis
QIAGEN has introduced the QIAstat-Dx Gastrointestinal Panel 2 in the United States, following its clearance by the U.S. FDA. This new panel offers rapid and accurate identification of up to 16 common gastrointestinal pathogens, significantly enhancing the diagnosis and treatment of GI infections.
Sanofi and Denali Therapeutics' SAR443820 Fails in Phase 2 ALS Trial
- Sanofi and Denali Therapeutics' SAR443820 (DNL788) did not meet primary or secondary endpoints in a Phase 2 study for amyotrophic lateral sclerosis (ALS).
- The investigational RIPK1 inhibitor did not demonstrate significant clinical benefit in ALS patients, leading to the termination of its development for this indication.
- The failure underscores the challenges in developing effective treatments for ALS, a progressive neurodegenerative disease with limited therapeutic options.
FDA Accepts Stealth BioTherapeutics' NDA for Elamipretide in Barth Syndrome
- The FDA has accepted Stealth BioTherapeutics' NDA for elamipretide, a potential first-in-class therapy for Barth syndrome, a rare genetic condition.
- The NDA is supported by positive data from the SPIBA-001 Phase 3 study and the TAZPOWER Part 2 trial, highlighting elamipretide's efficacy and safety.
- The FDA plans to hold an advisory committee meeting to discuss the application, indicating a thorough review process for this potential treatment.
- Elamipretide has received Fast Track, Orphan Drug, and Rare Pediatric Disease designations, underscoring the urgent need for Barth syndrome therapies.
Newron & Myung Collaborate for Evenamide Development in South Korea
Newron Pharmaceuticals partners with Myung In Pharm to advance the development, production, and commercialization of evenamide, a treatment for treatment-resistant schizophrenia, in South Korea. The collaboration includes a Phase III clinical trial set to begin in 2025.
SABCS 2024: Key Clinical Trials Highlight Advances in Breast Cancer Treatment
- The EMBER3 trial suggests combining imlunestrant with abemaciclib could be more effective than imlunestrant alone for advanced ER-positive, HER2-negative breast cancer.
- PATINA trial results indicate that adding palbociclib to anti-HER2 therapy and endocrine therapy significantly improves progression-free survival in HR-positive, HER2-positive metastatic breast cancer.
- OlympiA trial update shows olaparib as adjuvant therapy reduces the risk of death by 28% in patients with germline BRCA1/2 mutations and high-risk HER2-negative breast cancer.
- SOLTI-VALENTINE study supports HER3-DXd's effectiveness in early breast cancer, demonstrating similar response rates to chemotherapy with fewer severe adverse events.
Highlighted Clinical Trials:
Alliance Foundation Trials, LLC.
Posted 6/21/2017
AstraZeneca
Posted 4/22/2014
Hoffmann-La Roche
Posted 1/29/2020
Eli Lilly and Company
Posted 10/4/2021
Novartis Pharmaceuticals
Posted 12/7/2018
SOLTI Breast Cancer Research Group
Posted 11/25/2022
ImPact Biotech Reports 77% Complete Response Rate for Padeliporfin VTP in Low-Grade Upper Tract Urothelial Cancer
- ImPact Biotech's Phase 3 ENLIGHTED trial demonstrated a 77% complete response rate (10/13 patients) for Padeliporfin VTP therapy in low-grade upper tract urothelial cancer patients who completed the induction treatment phase.
- The vascular targeted photodynamic therapy showed a favorable safety profile with primarily Grade 1-2 adverse events that resolved within two to seven days, and no Grade 4 or 5 serious adverse events.
- The minimally invasive treatment offers a potential organ-sparing alternative to surgery for UTUC patients, with enrollment completion expected by end of 2024 and additional interim analysis planned for second half 2024.
Caribou Biosciences Reports Positive Clinical Data from CB-010 ANTLER Phase 1 Trial
Caribou Biosciences has presented encouraging clinical data from its ANTLER Phase 1 trial of CB-010, an allogeneic CAR-T cell therapy, showing potential to match the efficacy and safety of approved autologous CAR-T cell therapies. The data, presented at the 2024 ASCO Annual Meeting, highlights improved progression-free survival in patients with partial HLA matching and outlines plans for further trials.
Highlighted Clinical Trials:
Caribou Biosciences, Inc.
Posted 5/26/2021
Merck's KEYTRUDA Shows Promise in Platinum-Resistant Ovarian Cancer Trial
- Merck's Phase 3 KEYNOTE-B96 trial met its primary endpoint of progression-free survival for patients with platinum-resistant recurrent ovarian cancer treated with KEYTRUDA plus chemotherapy.
- The study demonstrated significant overall survival benefits among patients whose tumors express PD-L1 (Combined Positive Score ≥1), marking the first time a KEYTRUDA-based regimen has shown potential to extend survival in this challenging cancer type.
- The safety profile remained consistent with previous studies, with no new safety signals identified during the independent Data Monitoring Committee analysis.
- These positive results represent a major advancement for platinum-resistant ovarian cancer patients and further validate KEYTRUDA's role in gynecological malignancies.
Highlighted Clinical Trials:
Merck Sharp & Dohme LLC
Posted 1/10/2021
Intellia's CRISPR Gene Therapy Shows Potential as Functional Cure for Hereditary Angioedema in Long-Term Study
- Intellia Therapeutics' NTLA-2002, an in vivo CRISPR-based gene editing therapy, demonstrated a 98% mean reduction in monthly hereditary angioedema attack rates across all patients, with follow-up extending beyond two years.
- Eight of ten patients remained completely attack-free following the initial 16-week observation period, with the longest attack-free duration reaching over 26 months and continuing.
- The single-dose treatment showed a favorable safety profile across all dose levels, with no serious adverse events reported, positioning NTLA-2002 as a potential functional cure for this rare genetic disease.
Highlighted Clinical Trials:
Intellia Therapeutics
Posted 12/10/2021