Clinical Trial News
Sanofi and Regeneron Announce AIM4 Trial to Advance Personalized Asthma Treatment
• Sanofi and Regeneron revealed plans at ATS 2025 to launch the innovative AIM4 clinical trial, focusing on personalized treatment approaches for asthma patients.
• The trial represents a significant advancement in precision medicine for respiratory care, aiming to match patients with optimal therapies based on their specific asthma phenotypes.
• This initiative builds on the companies' existing respiratory portfolio and reflects the growing industry trend toward tailored therapeutic strategies for chronic respiratory conditions.
FDA Grants First-Ever Clearance for Pediatric Functional Dyspepsia Treatment to NeurAxis's IB-Stim
• NeurAxis has received FDA 510(k) clearance for IB-Stim to treat Functional Abdominal Pain associated with Functional Dyspepsia and related nausea symptoms in patients aged 8-21 years.
• This represents the first-ever FDA-cleared treatment for functional dyspepsia, potentially doubling NeurAxis's addressable market while utilizing existing reimbursement infrastructure.
• IB-Stim uses Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, offering a non-surgical alternative in a therapeutic area with no FDA-approved drug treatments for children.
FDA Greenlights Promontory Therapeutics' Phase 3 Trial Design for PT-112 in Metastatic Prostate Cancer
• Promontory Therapeutics has successfully completed an End of Phase 2 meeting with the FDA, reaching agreement on key aspects of a registrational Phase 3 trial for PT-112 in metastatic castration-resistant prostate cancer.
• The FDA approved the proposed dosing regimen, patient population, study comparator, and endpoints, with an interim analysis provision that could allow for drug approval before study completion.
• Preliminary clinical outcomes from the Phase 2 trial of PT-112 will be presented at the upcoming ASCO 2025 Annual Meeting on June 2nd, following recent presentation of immune response biomarker data at AACR 2025.
Highlighted Clinical Trials:
National Cancer Institute (NCI)
Posted 4/6/2022
Promontory Therapeutics Inc.
Posted 7/1/2014
FDA Overhauls COVID-19 Vaccine Approval Process, Limiting Access for Healthy Adults and Children
• The FDA has announced major changes to COVID-19 vaccine approvals, requiring placebo-controlled clinical trials for shots intended for healthy adults and children, effectively ending routine annual approvals for these groups.
• Under the new framework, COVID-19 vaccines will remain readily available through streamlined approvals only for adults 65 and older and those with health conditions that increase risk of severe COVID-19.
• The policy shift, spearheaded by FDA Commissioner Marty Makary and vaccine chief Vinay Prasad, represents a significant departure from the previous "one-size-fits-all" approach to COVID-19 vaccination recommendations.
Maipl Therapeutics and Endosure Form Alliance to Accelerate Non-Hormonal Endometriosis Treatment Development
• Maipl Therapeutics has partnered with Endosure to utilize the ENDOSURE TEST for expediting clinical trials of MA-4604, a novel non-hormonal endometriosis treatment targeting the Prostaglandin-F2α receptor.
• The ENDOSURE TEST offers >99% sensitivity in diagnosing endometriosis non-invasively in just 30 minutes, potentially reducing the 8-10 year average diagnostic delay that affects approximately 200 million women worldwide.
• MA-4604, positioned to be the first FP receptor antagonist in human trials, has demonstrated promising preclinical results in reducing uterine contractions, lesion burden, and pain response, with Phase 1 studies expected to begin in Q2 2026.
ADDF Invests $2.16 Million in Life Molecular Imaging's Novel PET Tracer for Alzheimer's Neuroinflammation
• Life Molecular Imaging has secured $2.16 million from the Alzheimer's Drug Discovery Foundation to develop [18F]F-DED, a PET imaging agent targeting MAO-B to visualize neuroinflammation in Alzheimer's disease.
• The three-year research collaboration with Ludwig-Maximilian University and Barcelona Beta Brain Research Center aims to investigate neuroinflammation's role in disease progression across both sporadic and genetic Alzheimer's cases.
• This innovative approach could overcome previous challenges in neuroinflammation imaging caused by genetic polymorphisms, potentially revealing critical insights into how inflammation contributes to tau pathology spread in Alzheimer's disease.
ACT Technology Shows Promising Results in Enhancing Chemotherapy for Colorectal Liver Metastases
• EXACT Therapeutics' Phase 1 ACTIVATE trial demonstrates that Acoustic Cluster Therapy (ACT) significantly enhances chemotherapy effectiveness, with ACT-treated tumors showing 29% reduction in diameter compared to 7% with chemotherapy alone.
• The innovative treatment demonstrated a clear dose-response relationship, with higher doses (40 μl/kg) of PS101 producing greater tumor shrinkage than lower doses (20 μl/kg), while maintaining an excellent safety profile.
• These positive results support advancement to the Phase 2 ENACT trial targeting pancreatic cancer, potentially offering new hope for patients with difficult-to-treat solid tumors.
Highlighted Clinical Trials:
EXACT Therapeutics AS
Posted 9/17/2019
Novel AAV Capsid Variant Shows Superior Gene Delivery to Brain Regions Affected by Huntington's and Parkinson's
• Latus Bio's AAV-DB-3 capsid variant demonstrates gene transfer to neurons in deep brain and cortical regions at 10-100 times lower doses than current clinical standards.
• The novel vector achieves over 180-fold higher transgene mRNA expression in Huntington's disease-relevant brain regions compared to wild-type AAV5 in non-human primates.
• AAV-DB-3 specifically targets medium spiny neurons of the striatum and projection neurons of the cortex, the same regions affected in Huntington's and Parkinson's diseases.
Doron Therapeutics Advances MOTYS for Knee Osteoarthritis Following Successful FDA Meeting
• Doron Therapeutics has successfully completed its End-of-Phase 2 and initial RMAT meeting with the FDA for MOTYS (PTP-001), confirming the design and endpoints for its upcoming Phase 3 program in knee osteoarthritis.
• The Phase 3 study will be a multi-site, multi-national, placebo-controlled trial involving approximately 300 patients, evaluating improvements in both pain and function for up to 12 months after a single MOTYS injection.
• MOTYS, a regenerative biologic derived from placental tissues, has received both FastTrack and RMAT designations from the FDA, positioning it as a potential breakthrough in a therapeutic area with limited innovation.
Minghui Pharmaceutical Initiates Phase II Trial Combining PD-1xVEGF Bispecific with TROP-2 ADC for Advanced NSCLC
• Minghui Pharmaceutical has dosed the first patient in a Phase II trial evaluating the combination of MHB039A (PD-1xVEGF bispecific antibody) and MHB036C (TROP-2 ADC) in advanced non-small cell lung cancer patients.
• MHB039A demonstrated full blocking activities against both targets with superior PD-1 activity compared to competitors, while MHB036C showed promising anti-tumor activity in heavily pre-treated NSCLC and breast cancer patients.
• The novel combination approach aims to achieve more robust and durable anti-tumor responses, potentially reshaping standard-of-care treatment paradigms for NSCLC and other solid tumors.