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Clinical Trial News

Elite Pharmaceuticals Achieves Bioequivalence for Generic Anticoagulant in $27 Billion Market

FDA Approval
  • Elite Pharmaceuticals reported positive bioequivalence results for an undisclosed generic anticoagulant targeting a branded product with $27 billion in annual sales.
  • The crossover bioequivalence study in healthy subjects demonstrated that Elite's generic formulation is bioequivalent to the branded reference product.
  • The company is preparing to file an Abbreviated New Drug Application with the FDA, though commercialization depends on patent resolution and regulatory approval.
  • No generic competitor currently exists in this anticoagulant market, presenting a significant commercial opportunity for Elite upon successful market entry.

D&D Pharmatech's DD01 Shows Rapid Liver Fat Reduction in MASH Phase 2 Trial, Matching Competitor Results in Quarter of the Time

  • D&D Pharmatech's DD01 achieved 75.8% of patients with at least 30% liver fat reduction in just 12 weeks, matching Boehringer Ingelheim's servodutide results that required 48 weeks of treatment.
  • The dual GLP-1/glucagon receptor agonist demonstrated superior tolerability with only 9.09% treatment discontinuation due to gastrointestinal side effects compared to 20% for competing drugs.
  • DD01 showed significant improvements in non-invasive MASH markers including liver stiffness and proC3 levels, with 48.5% of patients achieving normal liver fat levels within 12 weeks.
  • The drug's unique pharmacokinetic profile allows for rapid therapeutic dosing without lengthy titration periods, potentially offering advantages in clinical management of MASH patients.

A Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570

NCT06000891TerminatedPhase 1
Zealand Pharma
Posted 9/15/2023

A Study to Evaluate DD01 in Overweight/Obese Subjects With MASLD/MASH

NCT06410924Active, Not RecruitingPhase 2
Neuraly, Inc.
Posted 6/13/2024

Circle Pharma's CID-078 Receives FDA Orphan Drug Designation for Small Cell Lung Cancer Treatment

  • Circle Pharma announced that the FDA has granted Orphan Drug Designation to CID-078 for treating small cell lung cancer, a highly aggressive cancer affecting 13-15% of lung cancer cases.
  • The designation provides seven years of market exclusivity upon approval, tax credits for clinical trials, and eligibility for FDA research grants to support development.
  • CID-078 is an orally bioavailable macrocycle that targets cyclin A and B proteins, with a Phase 1 clinical trial currently enrolling patients with advanced solid tumors.
  • Small cell lung cancer has a poor prognosis with high recurrence rates despite existing treatments, highlighting the urgent need for new therapeutic options.

Safety/Efficacy Study of CID-078 in Patients With Advanced Solid Tumor Malignancies

NCT06577987RecruitingPhase 1
Circle Pharma
Posted 8/14/2024

NextCure and Simcere Zaiming Form Strategic Partnership for CDH6-Targeting ADC SIM0505

Oncology
  • NextCure gains global rights to SIM0505, a novel antibody-drug conjugate targeting CDH6 for solid tumors, while Simcere Zaiming retains Greater China rights.
  • The partnership includes potential milestone payments up to $745 million plus tiered royalties, with U.S. Phase 1 trials expected to begin in Q3 2025.
  • SIM0505 features a proprietary topoisomerase 1 inhibitor payload designed for broad anti-tumor activity with high systemic clearance to improve the therapeutic window.
  • Initial Phase 1 clinical data is anticipated in the first half of 2026, following ongoing dose escalation studies in China.

Incyte's INCA033989 Shows 86% Response Rate in CALR-Mutant Blood Cancer Trial

Monoclonal AntibodyPrecision Medicine
  • Incyte's experimental monoclonal antibody INCA033989 demonstrated an 86% complete or partial hematologic response rate in patients with CALR-mutant myeloproliferative neoplasms receiving doses of 400 mg or higher.
  • The company announced a precision medicine collaboration with Qiagen to develop next-generation sequencing diagnostics for detecting CALR mutations, the second most common driver of MPNs.
  • Clinical data from dose-escalation studies showed 89% of evaluable patients had reduced mutant CALR variant allele frequency, with 21% achieving partial molecular response within three treatment cycles.
  • Stifel upgraded Incyte to 'Buy' rating with a $107 price target following the encouraging clinical results presented at the European Hematology Association congress.

Pierre Fabre Acquires Global Rights to Next-Generation EGFR Inhibitors for NSCLC Treatment

Targeted TherapyPrecision MedicineOncology
  • Pierre Fabre Laboratories acquired worldwide rights to PFL-721 and PFL-241 from Antares Therapeutics, expanding their oncology pipeline with mutant-specific EGFR inhibitors targeting unmet needs in non-small cell lung cancer.
  • PFL-721 is a dual EGFR exon 20 and HER2 exon 20 inhibitor transitioning to dose optimization in first-in-human trials, while PFL-241 is a brain-penetrant fourth-generation EGFR inhibitor addressing C797S resistance mutations.
  • EGFR mutations drive approximately 14-38% of NSCLC tumors globally, representing a significant patient population with substantial therapeutic needs.
  • The acquisition consolidates Pierre Fabre's complete ownership of their R&D portfolio including exarafenib and PFL-002, positioning the company to advance precision medicine development for cancer patients.

Revolutionary Blood Test Enables Celiac Disease Diagnosis Without Gluten Challenge

  • A new blood test can accurately diagnose celiac disease even in patients already following a gluten-free diet, eliminating the need for painful gluten challenges that worsen symptoms.
  • The test measures interleukin-2 (IL-2) immune response to gluten in blood samples, achieving 90% sensitivity and 97% specificity in detecting celiac disease.
  • Researchers tested 181 volunteers and found the IL-2 signal strength correlates with symptom severity, potentially predicting how severely patients might react to gluten exposure.
  • The breakthrough could help diagnose millions of undiagnosed celiac patients worldwide who avoid current testing due to the debilitating diagnostic process.

BlueGenes and Levrx Partner to Integrate Real-Time Pharmacogenetic Testing into Pharmacy Benefit Systems

Precision Medicine
  • BlueGenes and Levrx Technology have formed a strategic partnership to integrate real-time genetic testing insights into pharmacy benefit systems, aiming to accelerate personalized prescribing adoption.
  • The collaboration addresses the critical issue of adverse drug reactions, which cause more than 100,000 deaths annually in the U.S., with BlueGenes targeting a 50% reduction in these fatalities.
  • The integrated solution identifies genetic risks and safer medication alternatives during claims processing, delivering actionable insights through Levrx's digital platform without requiring additional platforms or behavior changes from providers.
  • This partnership represents a shift from passive data collection to proactive decision-making in medication safety, potentially establishing a new standard for personalized healthcare delivery.

Onco-Innovations Partners with University of Alberta to Advance PNKP Inhibitor Research for Glioblastoma Treatment

Oncology
  • Onco-Innovations has entered into a research agreement with the University of Alberta and Cross Cancer Institute to expand preclinical studies of its PNKP inhibitor technology for hard-to-treat cancers, beginning with glioblastoma multiforme.
  • The study will focus on evaluating the therapeutic potential of the company's second-generation nanoparticle formulation of PNKP inhibitors against GBM, which accounts for approximately 50% of all primary malignant brain tumors and affects over 200,000 individuals worldwide annually.
  • Research will be led by Dr. Michael Weinfeld, the original discoverer of the PNKP inhibitor technology, with the preclinical program scheduled to begin in the third quarter of 2025.
  • Key investigation areas will include pharmacological characteristics, DNA damage enhancement in tumor models, effects on normal brain tissue, and potential combination strategies with standard-of-care therapies.

Varenicline-Bupropion Combination Shows Promise for Alcohol Use Disorder Treatment

  • A 13-week randomized trial of 384 patients with moderate to severe alcohol use disorder found that combining varenicline and bupropion produced approximately twice the effect of currently available medications.
  • The combination therapy significantly reduced alcohol consumption and cravings by targeting dopamine deficiency, which researchers hypothesize drives alcohol craving behavior.
  • Patients receiving the combination treatment experienced less nausea and shorter symptom duration compared to varenicline alone, potentially improving treatment completion rates.
  • The study provides pharmacological support for the dopamine deficiency hypothesis of alcohol use disorder and represents a significant advancement in addressing this condition that can reduce life expectancy by 25 years or more.

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