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Clinical Trial News

Samsung Bioepis Reports Sustained Safety Profile for EPYSQLI Biosimilar in Long-Term PNH Study

  • Samsung Bioepis presented long-term safety data for EPYSQLI (eculizumab biosimilar) showing consistent safety outcomes between the initial 52-week period and extended treatment up to 158 weeks in PNH patients.
  • The study found no new safety signals or fatal cases throughout the entire treatment period, with exposure-adjusted event rates remaining comparable between periods (0.13 vs 0.17, p=0.76).
  • EPYSQLI has received regulatory approval from the European Commission for PNH and aHUS treatment, with the biosimilar administered at 900 mg every two weeks during maintenance therapy.
  • All serious adverse events during the extended treatment period resolved completely without permanent treatment discontinuation, supporting the drug's long-term tolerability profile.

SNIPR Biome Doses First Patient with CRISPR-Armed Phage Therapy SNIPR001 for Drug-Resistant E. coli Prevention

Precision Medicine
  • SNIPR Biome has dosed the first patient in its Phase 1b trial of SNIPR001, a CRISPR-armed phage therapy targeting fluoroquinolone-resistant E. coli in hematological cancer patients undergoing stem cell transplantation.
  • The therapy combines four engineered bacteriophages that specifically target drug-resistant E. coli in the gut microbiome while preserving beneficial bacteria, addressing a critical unmet need in cancer care.
  • The randomized, double-blind, placebo-controlled trial will evaluate safety, tolerability, and efficacy in 24 patients across eight US centers, building on promising Phase 1a safety data in healthy volunteers.
  • E. coli causes 25-30% of bacteremia cases in neutropenic hematological cancer patients, with up to 65% showing fluoroquinolone resistance, making this precision approach potentially transformative for vulnerable patient populations.

Phase 1b/2a Randomized Double-blind Study to Investigate Safety Tolerability PK PD Preliminary Efficacy of Oral Administration of SNIPR001 in Patients With Hematologic Malignancy Scheduled for Allogeneic Hematopoietic Stem-Cell Transplant Receiving FQ Prophylaxis & Harboring FQR Ecoli PreTransplant

NCT06938867RecruitingPhase 1
SNIPR Biome Aps.
Posted 2/25/2025

Cytovale's IntelliSep Diagnostic Reduces Sepsis Mortality by 39% in Large Real-World Study

Real World Evidence
  • Cytovale's FDA-cleared IntelliSep diagnostic achieved a 39% relative reduction in sepsis mortality in a real-world study of over 12,000 patients at Our Lady of the Lake Regional Medical Center.
  • The rapid diagnostic test delivers results in eight minutes from a routine blood draw and reduced average hospital length of stay by 0.76 days for sepsis patients.
  • The study demonstrated improved resource allocation with a 40% decrease in blood culture usage for low-risk patients and an 8% increase for high-risk cases.
  • Following successful validation, the health system has expanded IntelliSep implementation across four additional sites within Franciscan Missionaries of Our Lady Health System.

MRO Acquires Q-Centrix to Create Comprehensive Clinical Data Management Platform

  • MRO Corp. has acquired Q-Centrix, an enterprise clinical data management platform from TPG Growth, creating a category-defining solution for healthcare data exchange.
  • The combined entity will serve over 2,000 hospitals and health systems, more than 7,000 clinics, and nearly 250 payers across the healthcare ecosystem.
  • The acquisition aims to transform fragmented clinical data into actionable insights, supporting better patient care, operational efficiency, and breakthrough research.
  • The deal is backed by healthcare technology investors including Parthenon Capital, though financial terms were not disclosed.

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

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

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

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

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.

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