Clinical Trial News
FDA Approves Avacincaptad Pegol for Geographic Atrophy
The FDA has approved avacincaptad pegol (IZERVAY) for treating geographic atrophy secondary to age-related macular degeneration, marking a significant advancement in addressing this form of vision loss.
FDA Approves Zuranolone: First Oral Treatment for Postpartum Depression
- The FDA has approved zuranolone, marketed as a once-daily oral medication, marking the first treatment specifically for postpartum depression (PPD).
- Clinical trials demonstrated significant improvements in depressive symptoms for women taking zuranolone compared to placebo, offering a new therapeutic option.
- Zuranolone represents a novel approach to PPD treatment, potentially improving access and reducing the burden of this common complication after pregnancy.
- The approval of zuranolone provides a much-needed alternative to existing treatments, addressing a significant unmet need in women's healthcare.
Targeting the Endothelin A Receptor in IgA Nephropathy: A New Therapeutic Approach
Recent advancements in the treatment of IgA Nephropathy (IgAN) focus on targeting the Endothelin-A receptor (ETAR) to mitigate renal deterioration. This approach is based on the understanding that ETAR activation contributes to various pathophysiological effects in the kidney, including vasoconstriction, inflammation, and fibrosis. Clinical trials have shown that ETAR blockade can reduce proteinuria and slow disease progression, offering a promising new avenue for IgAN treatment.
Highlighted Clinical Trials:
AstraZeneca
Posted 4/28/2021
Travere Therapeutics, Inc.
Posted 8/12/2021
Novartis Pharmaceuticals
Posted 7/20/2023
Chinook Therapeutics, Inc.
Posted 12/11/2020
Novartis Pharmaceuticals
Posted 3/15/2021
Travere Therapeutics, Inc.
Posted 12/11/2018
University of Leicester
Posted 12/10/2020
UGN-102 Shows Promise as Non-Surgical Option for Low-Grade Bladder Cancer
- UGN-102 met primary endpoints in Phase 3 ATLAS and ENVISION trials for low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
- The ATLAS trial demonstrated a 55% reduction in the risk of recurrence, progression, or death compared to TURBT alone, with similar complete response rates.
- In the ENVISION trial, UGN-102 achieved a 79.2% complete response rate at 3 months, suggesting potential as a primary chemoablative therapy.
- UroGen Pharma plans to submit a new drug application (NDA) to the FDA in 2024, pending further positive data on duration of response.
Highlighted Clinical Trials:
UroGen Pharma Ltd.
Posted 3/1/2022
UroGen Pharma Ltd.
Posted 2/19/2021
CAGE Bio's Topical Tofacitinib Shows Promise in Phase 2 Atopic Dermatitis Trial
- CAGE Bio's CGB-500, a topical formulation of 1% tofacitinib, demonstrated a 98% reduction in EASI scores compared to 28% with the vehicle in atopic dermatitis patients.
- The Phase 2 study achieved all primary and secondary endpoints, with 95% of patients in the active group achieving treatment success versus 24% in the vehicle group.
- CGB-500 was well-tolerated, with no treatment-emergent adverse events, suggesting a favorable safety profile for localized treatment of immuno-dermatological disorders.
- CAGE Bio plans to initiate dose ranging and registration trials to further validate the efficacy and safety of CGB-500 for regulatory submissions and potential approval.
Elraglusib Receives FDA Orphan Drug Designation for Pancreatic Cancer Treatment
- The FDA has granted Orphan Drug Designation to elraglusib, a GSK-3β inhibitor, for the treatment of patients with pancreatic cancer, addressing a high unmet medical need.
- Elraglusib is currently being evaluated in phase 2 trials, both as a monotherapy and in combination with other agents like gemcitabine and nab-paclitaxel, for advanced pancreatic cancer.
- The Orphan Drug Designation provides Actuate Therapeutics with benefits including assistance in drug development, tax credits, and potential marketing exclusivity.
- Elraglusib targets molecular pathways involved in tumor growth and resistance to chemotherapy, showing promise as a novel therapeutic approach for pancreatic cancer.
Highlighted Clinical Trials:
Anwaar Saeed
Posted 1/26/2022
Actuate Therapeutics Inc.
Posted 1/4/2019
Colin D. Weekes, M.D., PhD
Posted 3/21/2022
Transcranial Random Noise Stimulation Shows Promise in Pediatric ADHD
- A clinical trial found that transcranial random noise stimulation (tRNS) combined with cognitive training may alleviate ADHD symptoms in children.
- 55% of parents reported significant clinical improvement in their children's ADHD symptoms after tRNS treatment, compared to 17% in the placebo group.
- The study, involving 23 children aged 6-12, suggests tRNS has the potential to become a new therapeutic option for ADHD.
- Researchers are planning a larger clinical trial, with hopes of FDA approval for tRNS as a medical device for ADHD treatment.
TYRA Biosciences Receives FDA Orphan Drug Designation for TYRA-300 in Achondroplasia
- TYRA Biosciences received FDA Orphan Drug Designation for TYRA-300, an oral FGFR3 selective inhibitor, for treating achondroplasia, the most common form of dwarfism.
- TYRA-300 aims to address not only height but also long-term health complications like cranial and spinal stenosis associated with achondroplasia.
- A Phase 2 clinical study of TYRA-300 in pediatric achondroplasia is planned for 2024, following positive preclinical results and an upcoming IND submission.
- Michael Bober, M.D. Ph.D., a specialist in skeletal dysplasia, has been appointed VP, Clinical Development and Medical Affairs, to lead the TYRA-300 program.
Highlighted Clinical Trials:
Tyra Biosciences, Inc
Posted 11/22/2022
Obexelimab Shows Promise in Treating IgG4-Related Disease
A phase 2 pilot trial evaluating obexelimab, a novel monoclonal antibody, demonstrated significant clinical improvement in patients with IgG4-related disease, suggesting its potential as a treatment option without the need for prolonged B-cell depletion.
Highlighted Clinical Trials:
Xencor, Inc.
Posted 3/1/2016
AI Cancer Detection Tool Shows 13% Boost in Prostate Cancer Diagnosis, Expands to Breast Cancer Screening in Wales
- The Welsh NHS has reported a 13% increase in prostate cancer detection using the IBEX Galen AI platform during initial pilot studies at Betsi Cadwaladr Health Board.
- The successful AI diagnostic tool will be expanded to five additional health boards across Wales and extended to include breast cancer screening applications.
- The implementation is part of Wales' new digital health strategy, prioritizing AI-powered diagnostics to improve early detection and streamline cancer diagnosis workflows.