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Clinical Trial News

AbbVie's Qulipta Demonstrates Superior Tolerability and Efficacy Over Topiramate in Head-to-Head Migraine Prevention Trial

  • AbbVie's migraine prevention drug Qulipta showed significantly lower discontinuation rates compared to topiramate in a late-stage head-to-head trial, with only 12.1% of patients stopping treatment versus 29.6% for the generic drug at 24 weeks.
  • The study met all secondary endpoints, with 64.1% of Qulipta patients achieving a 50% or greater reduction in monthly migraine days compared to 39.3% of topiramate patients.
  • This clinical success supports AbbVie's strategic expansion into neuroscience as the company seeks to diversify beyond Humira, which faces increasing biosimilar competition.
  • Qulipta generated $658 million in international sales last year, highlighting its commercial potential in the migraine prevention market.

Singlera Genomics' GutSeer Assay Achieves 81.5% Sensitivity in Detecting Early-Stage Gastrointestinal Cancers

  • Singlera Genomics and Fudan University's Zhongshan Hospital published results from the GUIDE prospective cohort study in Molecular Cancer, demonstrating their GutSeer assay's ability to detect five major gastrointestinal cancers through a simple blood test.
  • The DNA methylation-based assay achieved 81.5% sensitivity and 94.4% specificity for cancer detection, with 66.4% of cancer patients in the cohort being early-stage (stage I/II).
  • GutSeer outperformed a low-pass WGS fragmentomics assay with an AUC of 0.963 versus 0.887, while also determining tissue-of-origin in 80.7% of cases and detecting 21.4% to 47.1% of precancerous lesions.

Establishment of Molecular Classification Models for Early Diagnosis of Digestive System Cancers

NCT05431621Completed
Shanghai Zhongshan Hospital
Posted 11/15/2020

Abbott Partners with MSD to Expand Distribution of Diabetes Drug Portfolio in India

  • Abbott and MSD Pharmaceuticals have formed a strategic distribution partnership to expand access to MSD's oral anti-diabetic portfolio in India, including sitagliptin and its fixed-dose combinations.
  • The agreement covers the distribution of sitagliptin-based brands Januvia, Janumet, and Janumet XR, which remain category leaders despite patent expiration in July 2022.
  • India's oral anti-diabetic drug market is valued at Rs 12,500 crore, with DPP-4 inhibitors accounting for Rs 4,000 crore, addressing a critical need for over 101 million diabetic patients.
  • The partnership represents a strategic response to post-patent landscapes, allowing multinational firms to maintain market presence through local distribution networks.

NervGen Appoints Randall Kaye as Chief Medical Advisor Following Positive Spinal Cord Injury Trial Results

  • NervGen Pharma has appointed Dr. Randall Kaye as Chief Medical Advisor to guide the clinical and regulatory strategy for NVG-291, following positive topline results from the chronic cohort of their Phase 1b/2a spinal cord injury trial.
  • Dr. Kaye brings extensive CNS therapeutic development experience, having previously served as CMO at Longboard Pharmaceuticals through its $2.6 billion acquisition by H. Lundbeck A/S.
  • The appointment positions NervGen to advance NVG-291, a first-in-class therapeutic peptide with FDA Fast Track designation, toward an anticipated FDA meeting in the second half of 2025.
  • NVG-291 met its primary endpoint in the chronic cohort and demonstrated promising changes in hand function assessment, representing a potential breakthrough in neuroreparative therapeutics.

Curasight Advances uTREAT Brain Cancer Therapy with Phase 1 Trial Submission to EMA

Targeted Therapy
  • Curasight A/S has submitted a Clinical Trial Application to the European Medicines Agency for a Phase 1 trial of uTREAT, a targeted radiopharmaceutical therapy for glioblastoma patients.
  • The therapy targets the uPAR receptor, with recent Phase II data showing 94% of Grade 4 gliomas were uPAR-positive, supporting the treatment's potential in this aggressive brain cancer.
  • Glioblastoma affects approximately 30,000 patients annually in the US and EU, with a devastating prognosis where only 5% of patients survive five years after diagnosis.
  • The company has partnered with Premier Research as the contract research organization to conduct the international Phase 1 trial, with first patient dosing expected in the second half of 2025.

Akari Therapeutics Secures India Patent for Novel Spliceosome-Inhibiting ADC Payload Technology

  • Akari Therapeutics received Patent No. 562,919 from India's Intellectual Property Office for its novel PH1 payload, a spliceosome inhibitor that disrupts RNA splicing to kill cancer cells and activate immune responses.
  • The patent covers the company's immuno-oncology PH1 payload, proprietary linkers, and ADC technology with applications across various cancer targets, strengthening global IP protection.
  • India represents a strategic market with cancer cases projected to reach 2.08 million by 2040, highlighting the growing need for innovative cancer therapies.
  • The company's lead candidate AKTX-101 targets Trop2 receptors and has demonstrated significant tumor-killing activity and prolonged survival in preclinical studies compared to traditional ADC payloads.

Respiratorius Secures FDA Pre-IND Meeting for VAL001 Cancer Treatment Following Positive Physician Survey

Oncology
  • Respiratorius has been granted a pre-IND meeting with the FDA for VAL001, an innovative oral formulation of sodium valproate designed as pre-treatment for cancer therapy, particularly Diffuse Large B-cell Lymphoma.
  • A comprehensive physician survey across the U.S., Europe, and Japan involving 135 treating physicians and key opinion leaders found that over 70% would be willing to prescribe VAL001, citing favorable clinical efficacy and established safety profile.
  • Commercial analysis projects VAL001 could achieve annual sales of USD 190 million at estimated market penetration, with cumulative revenue of USD 2.3 billion over the period of market exclusivity.
  • The company has secured patent protection for VAL001's formulation across key markets including the U.S., Europe, Japan, and Canada, with the European patent recently granted providing at least 20 years of market exclusivity.

Infinity Bio Secures $8M Series A to Advance Antibody Reactome Profiling Technology

  • Infinity Bio closed an $8 million Series A financing round led by Illumina Ventures to expand its proprietary MIPSA™ antibody reactome profiling platform.
  • The biotechnology company acquired assets from Serimmune, Inc. to broaden its immune profiling service offerings and plans to launch new services in 2025.
  • The platform enables high-resolution analysis of antibody responses against viruses, human proteins, and allergens, supporting biomarker discovery and therapeutic development.
  • Founded in 2023, Infinity Bio operates a 9,000 square-foot laboratory in Baltimore capable of processing thousands of samples per week for academic, government, and biopharma customers.

Climb Bio Strengthens Leadership Team with Key Executive Appointments to Advance Immune-Mediated Disease Pipeline

Monoclonal Antibody
  • Climb Bio appointed Edgar D. Charles, M.D., MSc as Chief Medical Officer, bringing over 20 years of immunology-focused pharmaceutical development experience from Bristol Myers Squibb and Merck & Co.
  • The company also hired Cindy J. Driscoll, MBA as Senior Vice President, Finance, a seasoned executive with over two decades of biotechnology industry experience.
  • Dr. Charles will lead clinical development of budoprutug, an anti-CD19 monoclonal antibody, and CLYM116, an anti-APRIL monoclonal antibody for immune-mediated diseases.
  • The appointments come at a pivotal time as Climb Bio prepares to execute clinical studies for both therapeutic programs targeting B-cell mediated diseases.

Pattern Computer Advances AI-Discovered Drug for Multiple Hard-to-Treat Cancers to Testing Phase

Precision Medicine
  • Pattern Computer has developed a novel AI-discovered drug using CRISPR technology that targets a protein not expressed in healthy adult tissue but present in aggressive early-onset colorectal cancer patients.
  • The company's Pattern Discovery Engine identified a genetic signature that increases colorectal cancer risk by 200% in individuals under 45 years old, leading to both a new diagnostic tool and therapeutic target.
  • Initial testing will focus on early-onset colorectal cancer, with potential applications across multiple hard-to-treat cancers including ovarian, lung, breast, pancreatic, and brain cancers.
  • The drug is designed with genome-wide specificity for a single target and aims to block metastasis while reducing tumor growth with minimal toxicity.

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