Clinical Trial News
Experimental Medication Shows Promise in Treating Cocaine Addiction
• A novel experimental medication targeting brain reward pathways has demonstrated efficacy in helping people with cocaine addiction reduce their drug use, addressing a significant unmet medical need.
• Current addiction treatment options exist for alcoholism and opioid use disorder, but no FDA-approved medications are available for stimulant addictions like cocaine, which contribute to approximately half of all overdose deaths in the US.
• In a separate small trial, an experimental vaccine designed to prevent cocaine from reaching the brain showed promising results, with vaccinated participants 17% more likely to test negative for cocaine compared to those receiving placebo.
Philikos Initiates Phase 1/2 Trial of T-Guard for Diffuse Cutaneous Systemic Sclerosis
• Philikos has enrolled the first patient in a Phase 1/2 trial evaluating T-Guard for diffuse cutaneous systemic sclerosis (dcSSc), a severe autoimmune disorder with limited treatment options.
• The open-label study will assess safety and preliminary efficacy in 12 early-stage dcSSc patients whose disease remains refractory despite prior immunosuppressive therapy.
• T-Guard, administered as four infusions over one week, aims to provide a safer alternative to hematopoietic stem cell transplantation by selectively depleting disease-associated T cells and NK cells.
Imec Unveils Revolutionary Miniaturized Ingestible Sensor for Non-Invasive Gut Health Monitoring
• Imec has developed a highly miniaturized ingestible sensor measuring just 2.1cm in length and 0.75cm in diameter, three times smaller than existing capsule endoscopies, capable of monitoring gut health for up to a week.
• The innovative device is the first to measure redox balance, a marker for oxidative stress and inflammation, alongside pH and temperature throughout the entire gastrointestinal tract without requiring unpleasant bowel preparation.
• Following successful testing in healthy volunteers, Imec plans to evaluate the sensor in patient populations with cancer and inflammatory disorders in collaboration with Radboud University Medical Center.
Avicanna Sponsors Phase II Clinical Trial to Evaluate Cannabis Extracts for Osteoarthritis Pain
• Avicanna Inc. has entered a Sponsored Research Agreement to fund a Phase II clinical study evaluating oral cannabis extracts for osteoarthritis pain, scheduled to begin in Fall 2025.
• The multi-center, blinded, randomized, placebo-controlled trial will be led by Dr. Hance Clarke at the University Health Network and is funded by a Canadian Institutes of Health Research grant.
• The study aims to assess the feasibility of a larger definitive trial by evaluating patient enrollment, protocol adherence, and data completeness for CBD and THC capsules in treating hip and knee osteoarthritis pain.
Biostate AI Secures $12M Series A to Revolutionize RNA Sequencing and Molecular Diagnostics
• Biostate AI has raised $12 million in Series A funding led by Accel to develop affordable RNA sequencing technology and AI-powered diagnostic models.
• The company's proprietary BIRT and PERD technologies reduce RNAseq costs by nearly an order of magnitude, enabling researchers to run 2-3 times more samples within existing budgets.
• Founded by former professors David Zhang and Ashwin Gopinath, Biostate AI aims to build "foundation models" for molecular medicine by analyzing billions of RNA expressions to predict disease evolution and drug responses.
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.