Clinical Trial News
Industry Survey Reveals Healthcare Mistrust as Major Barrier to Clinical Trial Diversity
- A third of pharmaceutical executives identify systemic healthcare mistrust as a significant obstacle to achieving diverse clinical trial enrollment, according to a new Trinity Life Sciences survey.
- Despite minorities comprising over 40% of the US population, only 5-10% of clinical trial participants represent minority groups, highlighting a critical representation gap in medical research.
- GSK emerges as an industry leader with 100% of its phase 3 trials incorporating diversity plans by end of 2022, while many companies await clearer FDA guidance on diversity requirements.
AbbVie's ABBV-951 (Foscarbidopa/Foslevodopa) Receives Complete Response Letter from FDA
- AbbVie received a Complete Response Letter (CRL) from the FDA for its New Drug Application for ABBV-951 (foscarbidopa/foslevodopa).
- The FDA's response cited observations from a third-party manufacturer inspection, unrelated to ABBV-951 or any AbbVie medicine.
- The CRL does not raise concerns regarding the safety, efficacy, or labeling of ABBV-951, including the delivery device.
- AbbVie is committed to addressing the FDA's concerns and bringing this therapy to advanced Parkinson's disease patients.
AskBio Initiates Phase 2 Trial of AB-1005 Gene Therapy for Parkinson's Disease
- AskBio's REGENERATE-PD, a Phase 2 clinical trial, has begun recruitment to evaluate AB-1005 for moderate-stage Parkinson's disease.
- AB-1005 is an investigational adeno-associated virus 2 (AAV2) glial cell line-derived neurotrophic factor (GDNF) gene therapy.
- The Phase 2 trial follows encouraging Phase 1b results, which demonstrated that AB-1005 was well-tolerated with no related serious adverse events.
- The study will enroll approximately 87 subjects across sites in the United States, UK, and Europe to assess the efficacy and safety of AB-1005.
Highlighted Clinical Trials:
AskBio Inc
Posted 6/11/2024
Brain Neurotherapy Bio, Inc.
Posted 10/3/2023
Generative AI Poised to Transform Clinical Trial Efficiency with 40% Faster Regulatory Submissions
- Generative AI technology shows promise in accelerating clinical trials by streamlining patient cohort selection, improving recruitment, and enhancing trial design processes with up to 30% increased efficiency in initial drug target assessment.
- The technology can reduce regulatory submission timelines by 40% through automated documentation generation, while potentially decreasing patient drop-off rates by 5-10% through personalized engagement strategies.
- Despite concerns about data accuracy and privacy compliance, healthcare organizations are implementing GenAI solutions with proper safeguards, though ROI considerations require careful evaluation of operational costs and development timelines.
FDA Grants Priority Review to Ionis' Olezarsen for Familial Chylomicronemia Syndrome
- The FDA has accepted Ionis Pharmaceuticals' NDA for olezarsen with Priority Review for treating adults with familial chylomicronemia syndrome (FCS).
- The FDA has set a target action date of December 19, 2024, for olezarsen and does not plan to hold an advisory committee meeting.
- Olezarsen is an investigational RNA-targeted medicine designed to lower triglyceride levels by reducing the production of apoC-III.
- Phase 3 trials are fully enrolled to evaluate olezarsen for severe hypertriglyceridemia (sHTG), with data expected in the second half of 2025.
Riliprubart Shows Promise as First-in-Class Treatment for Chronic Inflammatory Demyelinating Polyneuropathy
- Sanofi's riliprubart demonstrated significant disease-controlling benefits across all patient cohorts in a Phase 2 study for chronic inflammatory demyelinating polyneuropathy (CIDP), including those who failed standard treatments.
- The complement C1s inhibitor showed sustained efficacy for up to 48 weeks, with 87-92% of participants experiencing improvement or disease stabilization after 24 weeks of treatment.
- Riliprubart reduced neurofilament light chain levels by 35% across all cohorts, suggesting potential reduction in nerve damage, while also improving patient-reported fatigue and quality of life outcomes.
Highlighted Clinical Trials:
N-Power Medicine Secures Series B Funding to Enhance Oncology Clinical Trial Access
- N-Power Medicine raised Series B funding led by Merck Global Health Innovation Fund to expand its oncology clinic network and biopharmaceutical collaborations.
- The company's integrated data platform streamlines clinical trials and routine patient management, aiming to accelerate drug development timelines.
- N-Power's platform includes the Kaleido Registry, which has enrolled over 7,000 patients, and AI-enabled workflow automation to support oncologists.
- The funding will further N-Power's mission to integrate clinical research into everyday patient care, making trials more accessible to oncologists and patients.
Wegovy Demonstrates Greater Weight Loss in Women with Heart Failure, Study Finds
- A recent study found that Wegovy (semaglutide) led to more significant weight loss in women compared to men with heart failure with preserved ejection fraction (HFpEF).
- Women in the trial experienced an average weight loss of 9.6%, while men experienced a weight loss of 7.2% after 52 weeks on a 2.4mg dose of semaglutide.
- Despite the difference in weight loss, both sexes showed similar improvements in HFpEF symptoms, physical limitations, and exercise function.
- The research highlights the need for further investigation into the reasons for the discrepancy in weight loss between sexes and its impact on heart failure outcomes.
Sen-Jam Pharmaceutical Completes Enrollment for Phase 2 Upper Respiratory Infection COVID Therapeutic
Sen-Jam Pharmaceutical has successfully completed participant enrollment for the Phase 2 clinical trial of its therapeutic, SJP-002C, aimed at treating Upper Respiratory Infections (URIs) and COVID. The trial, conducted in partnership with Duke University, achieved full enrollment of 150 participants, with no serious side effects reported. SJP-002C is a multi-targeted anti-inflammatory with antiviral capabilities, offering a potential affordable treatment option. The company plans to seek FDA approval for Phase 3 trials and is exploring partnerships for further development and commercialization.
EMA Initiates Review of Roche's Elevidys for Duchenne Muscular Dystrophy
- The EMA has begun reviewing Roche's Elevidys, a gene therapy for Duchenne muscular dystrophy (DMD), potentially the first DMD gene therapy in Europe.
- The application is based on Phase 3 EMBARK trial data, which showed clinically meaningful benefits in key secondary functional endpoints.
- Elevidys is already approved in the US and several other countries for ambulatory patients with DMD, targeting the underlying genetic cause.
- Roche is also conducting studies like ENVOL and ENVISION to broaden Elevidys' label to include younger and older DMD patients.