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Clinical Trial News

Cognito Therapeutics' Spectris AD Demonstrates Significant Delay in Alzheimer's Disease Progression Through Non-Invasive Neuromodulation

  • Cognito Therapeutics' Spectris AD therapy showed meaningful delays in Alzheimer's disease progression, preserving daily activities for 4.83 months and delaying cognitive decline by 4.56 months in a post hoc analysis of the OVERTURE trial.
  • The non-invasive device uses synchronized light and sound stimulation at 40Hz gamma frequency to restore disrupted brain electrical activity in Alzheimer's patients, representing a physics-based alternative to traditional pharmacological approaches.
  • The therapy demonstrated strong safety profile with over 80% adherence rates and no observed ARIA risk, while currently being evaluated in the pivotal HOPE trial with FDA Breakthrough Device Designation.

Qlaris Bio Develops Novel Fixed-Dose Combination Therapy Targeting Unaddressed Component of Glaucoma Treatment

  • Qlaris Bio announced development of QLS-111-FDC, a preservative-free fixed-dose combination therapy combining QLS-111 and latanoprost for glaucoma treatment.
  • Phase 2 clinical data demonstrated QLS-111 achieved over 3 mmHg additional IOP reduction compared to latanoprost monotherapy without causing hyperemia or adverse events.
  • The combination targets episcleral venous pressure, the only component of intraocular pressure not addressed by currently FDA-approved glaucoma treatments.
  • QLS-111-FDC is being developed for patients with primary open-angle glaucoma, normal-tension glaucoma, and ocular hypertension requiring enhanced IOP control.

Qlaris Phase 2 Study of QLS-111 in POAG And/or OHT Patients

NCT06016972CompletedPhase 2
Qlaris Bio, Inc.
Posted 3/5/2024

Qlaris Study of QLS-111 in Combination With a PGA for OAG and/or OHT Patients

NCT06249152CompletedPhase 2
Qlaris Bio, Inc.
Posted 4/21/2024

Juvena Therapeutics Partners with Eli Lilly in AI-Driven Muscle Health Drug Discovery Collaboration

AIDrug Discovery
  • Juvena Therapeutics has entered a global licensing and multi-target research collaboration with Eli Lilly to discover and develop drug candidates that improve muscle health and body composition.
  • The partnership will leverage JuvNET, the world's first fully integrated AI-enabled screening platform for mapping therapeutic potential of stem cell-secreted proteins.
  • Under the agreement, Juvena will receive upfront payment, equity investment, and potential milestone payments while granting Lilly exclusive licenses to identified lead candidates.
  • The collaboration aims to address obesity, which affects one in eight people globally, by combining Lilly's metabolic disease expertise with Juvena's AI platform and stem-cell protein library.

Rutgers Study Challenges FDA Heart Safety Warning for Epilepsy Drug Lamotrigine

  • Rutgers Health researchers found lamotrigine safe in older adults with epilepsy, contradicting a 2020 FDA safety warning about potential heart risks.
  • The study analyzed data from over 158,000 adults with epilepsy, making it the largest investigation to date of lamotrigine's cardiac effects.
  • Researchers found no increased risk for heart rhythm problems or sudden cardiac arrest compared to levetiracetam, even in patients with existing heart conditions.
  • The findings suggest the FDA warning may have unnecessarily limited access to an effective epilepsy treatment for patients with cardiac histories.

RFK Jr. Replaces Entire CDC Vaccine Advisory Committee with Eight New Members

  • Health Secretary Robert F. Kennedy Jr. has replaced all 17 members of the CDC's Advisory Committee on Immunization Practices with eight new appointees, significantly downsizing the committee.
  • The new members include epidemiologist Martin Kulldorf, mRNA researcher Robert Malone, and other professionals who have previously criticized vaccine policies or COVID-19 measures.
  • Industry analysts view the committee overhaul as potentially negative for vaccine development companies, predicting more restrictive recommendations on vaccine uptake and use.
  • The unprecedented speed of appointments has raised questions about proper vetting procedures, with experts noting the usual process takes years of scrutiny for conflicts of interest.

Subcutaneous Oncology Drug Delivery Transforms Cancer Care with FDA-Approved Formulations

Drug Approval
  • Pharmaceutical companies are increasingly developing subcutaneous formulations of existing IV oncology treatments, with recent FDA approvals marking a significant shift in cancer care delivery methods.
  • Subcutaneous administration dramatically reduces treatment times, with some therapies transitioning from 4-hour IV infusions to 10-minute injections, improving efficiency for patients and providers.
  • The shift addresses critical healthcare challenges including nursing shortages and resource constraints by enabling faster patient turnover and reducing staffing requirements per treatment.
  • Major oncology drugs including bortezomib, rituximab, daratumumab, atezolizumab, and nivolumab have successfully transitioned to subcutaneous delivery, with pembrolizumab formulation upcoming.

Toripalimab Emerges as Preferred PD-1 Inhibitor for Metastatic Nasopharyngeal Carcinoma Despite Access Challenges

CAR-TTargeted Therapy
  • Toripalimab has received NCCN category 1 recommendation for nasopharyngeal carcinoma based on positive phase 3 data in both first-line and second-line settings, unlike pembrolizumab which showed negative results in the KEYNOTE-122 trial.
  • Clinical practitioners report easier insurance coverage for pembrolizumab compared to toripalimab, leading many to use pembrolizumab off-label in combination with chemotherapy despite inferior clinical evidence.
  • PD-1 inhibitors combined with chemotherapy represent the established standard of care for systemic recurrent nasopharyngeal carcinoma, with EBV levels serving as useful biomarkers for monitoring treatment efficacy.
  • Future treatment approaches may focus on novel combinations including CAR-T cell therapy, tumor-infiltrating lymphocytes, and targeted therapies like EGFR inhibitors to improve outcomes while reducing toxicity.

The Efficacy and Safety Study of TORIPALIMAB INJECTION Combined With Chemotherapy for Nasophapyngeal Cancer

NCT03581786CompletedPhase 3
Shanghai Junshi Bioscience Co., Ltd.
Posted 10/18/2018

PD-1 Blockade Combined With De-intensified Chemoradiotherapy Sparing Concurrent Cisplatin in Nasopharyngeal Carcinoma

NCT04907370Active, Not RecruitingPhase 3
Sun Yat-sen University
Posted 8/1/2021

Study of Pembrolizumab (MK-3475) in Platinum Pre-treated Recurrent/Metastatic Nasopharyngeal Cancer (MK-3475-122/KEYNOTE-122)

NCT02611960CompletedPhase 3
Merck Sharp & Dohme LLC
Posted 4/18/2016

Monopar Therapeutics Launches FDA-Authorized Expanded Access Program for uPAR-Targeted Radiopharmaceuticals in Advanced Cancers

Targeted Therapy
  • Monopar Therapeutics and EDNOC have received FDA authorization for an expanded access program providing MNPR-101-Zr imaging agent and MNPR-101-Lu therapeutic agent to patients with advanced solid tumors.
  • The program targets aggressive cancers including triple-negative breast, pancreatic, and colorectal cancers through selective targeting of the urokinase plasminogen activator receptor (uPAR).
  • EDNOC in Houston, Texas serves as the treatment center and is among the first private outpatient facilities designated as a Radiopharmaceutical Therapy Center of Excellence by SNMMI.
  • The expanded access program follows the initiation of Phase 1 clinical trials in Australia and represents continued progress in Monopar's radiopharmaceutical pipeline development.

MNPR-101-PCTA-177Lu Expanded Access Program (EAP) for Patients With Solid Tumor Cancer

NCT06980519available
Monopar Therapeutics

MNPR-101-DFO*-89Zr Expanded Access Program (EAP) for Patients With Solid Tumor Cancer

NCT06980506available
Monopar Therapeutics

Molecular Partners Reports Promising Response Rates with Optimized MP0533 Dosing in Relapsed/Refractory AML

  • Molecular Partners' tetraspecific T-cell engager MP0533 achieved over 30% response rate in relapsed/refractory AML patients using an accelerated dosing regimen in cohort 8.
  • One patient maintained a complete response beyond 6 months, demonstrating potential for durable clinical benefit with the optimized treatment protocol.
  • The company is advancing to cohort 9 with further dosing improvements and plans combination studies with azacitidine/venetoclax based on encouraging antitumor activity.
  • Data presented at EHA 2025 support continued dose optimization to maximize therapeutic exposure and clinical responses in this difficult-to-treat patient population.

Skin Biopsy Test Detects Neurodegenerative Biomarker in 75% of REM Sleep Disorder Patients

  • The Syn-One Test successfully detected phosphorylated alpha-synuclein in skin biopsies of 75% of patients with idiopathic REM sleep behavior disorder, closely mirroring the 73.5% conversion rate to neurodegenerative diseases within 12 years.
  • The NIH-sponsored Syn-Sleep Study enrolled 80 participants across 11 U.S. sites, with P-SYN positive individuals tending to be older and having longer duration of symptoms compared to negative participants.
  • This minimally invasive diagnostic approach could enable early detection of synucleinopathies like Parkinson's disease, dementia with Lewy bodies, and multiple system atrophy up to a decade before clinical symptoms emerge.
  • The test's ability to distinguish patients with underlying alpha-synuclein pathology from those with other causes of RBD could guide prognosis and facilitate enrollment in disease prevention trials.

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