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Clinical Trial News

Lipella Pharmaceuticals Secures Patent for MRI-Based Diagnostic Technology to Detect Interstitial Cystitis

  • Lipella Pharmaceuticals received U.S. Patent No. 12,326,492 for an MRI-based method to detect lesions in body cavities, specifically targeting interstitial cystitis diagnosis.
  • The patent provides protection through at least 2045 and covers technology that could enhance outcome assessments for mucosal disorders across Lipella's pipeline.
  • The diagnostic method utilizes a novel MRI contrast agent to non-invasively monitor lesion progression or regression in body cavities.
  • The technology could support Lipella's existing clinical programs including LP-310 for oral lichen planus, LP-10 for hemorrhagic cystitis, and LP-50 for bladder cancer.

Health Canada Proposes Elimination of Phase III Clinical Trials for Biosimilar Approvals

Drug Approval
  • Health Canada has released draft guidance that would eliminate the requirement for comparative Phase III clinical trials in biosimilar drug approvals, marking a significant policy reversal.
  • The proposed changes would limit clinical requirements to comparative pharmacokinetic studies and optional pharmacodynamic evaluations, focusing instead on extensive analytical similarity data.
  • This regulatory shift aligns with similar moves by the European Medicines Agency and FDA discussions that have led some companies to terminate or minimize Phase III biosimilar trials.
  • The consultation period for the draft guidance runs until September 8, 2025, with potential implementation representing a pivotal change in Canada's biosimilar regulatory landscape.

PHOENIX Study Launches World's Largest Pharmacogenomics Trial to Personalize Drug Prescribing in Scotland

Precision Medicine
  • The PHOENIX Study, one of the largest pharmacogenomics trials globally, will recruit up to 4,000 patients over two years to investigate how genetic profiles affect responses to 60 commonly prescribed NHS medications.
  • Around 15% of patients are expected to carry genetic variants that may reduce medication effectiveness or increase side effects, which currently go unnoticed without genetic testing.
  • Led by Professor Sandosh Padmanabhan at the University of Glasgow, the trial aims to provide real-world evidence for implementing precision medicine across Scotland's healthcare system.
  • Participants undergo simple genetic testing with results returned within days to help doctors determine optimal drug selection and dosing based on individual genetic makeup.

Taiwan's Jyong Biotech Raises $20M in Nasdaq IPO to Advance Botanical Urinary Disease Treatments

  • Jyong Biotech Ltd., a Taiwan-based biotechnology company specializing in plant-derived drugs for urinary system diseases, successfully priced its initial public offering at $7.50 per share, raising approximately $20 million in gross proceeds.
  • The company will allocate 40% of net proceeds to fund additional Phase III trials of its lead botanical drug candidate MCS-2 and its new drug application, representing the largest portion of the IPO funding strategy.
  • Jyong Biotech's ordinary shares are expected to commence trading on the Nasdaq Global Market under ticker symbol "MENS" on June 17, 2025, marking a significant milestone for the 23-year-old company founded in 2002.

Prometheus Laboratories Expands Precision-Guided Dosing Platform with New Tests for IBD Biologics

Precision MedicineMonoclonal Antibody
  • Prometheus Laboratories launched PredictrPK VDZ and PredictrPK UST, precision-guided dosing tests for vedolizumab and ustekinumab in IBD patients, expanding their platform to cover four major biologics.
  • The tests incorporate drug clearance measurements alongside traditional therapeutic drug monitoring to provide personalized dosing recommendations and optimize biologic exposure.
  • Clinical studies demonstrate that higher vedolizumab clearance is associated with 9-fold and 2-fold lower likelihood of endoscopic and clinical remission respectively in Crohn's disease patients.
  • A separate study of 213 IBD patients showed that 81% of healthcare providers found PredictrPK ADA helpful for selecting optimal adalimumab dosing and patient discussions about dose escalation.

Foresee Pharmaceuticals Completes Enrollment in Phase 3 Trial for Central Precocious Puberty Treatment

Rare Disease
  • Foresee Pharmaceuticals has completed enrollment in its Phase 3 Casppian trial evaluating leuprolide mesylate (FP-001) 42 mg controlled-release for central precocious puberty treatment.
  • The 48-week multicenter study aims to achieve ≥80% LH suppression in pediatric patients, with topline results expected by end of 2025.
  • Central precocious puberty affects 1 in 5,000 to 10,000 children and can lead to short adult stature and psychological complications.
  • The company plans to submit a New Drug Application to regulatory authorities by Q3 2026 following successful study completion.

Tisento Therapeutics Receives FDA Fast Track Designation for Zagociguat in MELAS Treatment

Rare Disease
  • The U.S. FDA has granted Fast Track designation to zagociguat for treating MELAS, a rare mitochondrial disease with no approved treatments.
  • Zagociguat is a first-in-class, brain-penetrant soluble guanylate cyclase stimulator that showed improvements in neuronal function and brain blood flow in Phase 2a studies.
  • The global Phase 2b PRIZM study is currently enrolling approximately 44 participants across multiple countries to evaluate zagociguat's efficacy and safety.
  • MELAS causes severe symptoms including chronic fatigue, cognitive dysfunction, muscle weakness, and stroke-like episodes, leading to reduced quality of life and shortened life expectancy.

A Phase 2b Study of Zagociguat in Patients With MELAS

NCT06402123RecruitingPhase 2
Tisento Therapeutics
Posted 9/10/2024

An Open-label Extension Safety Study of MELAS Patients Who Completed TIS6463-203 (PRIZM)

NCT06961344Unknown StatusPhase 2
Tisento Therapeutics
Posted 8/18/2025

Qureight's AI-Powered Synthetic Control Arms Validate Efficacy of Avalyn's Inhaled Pirfenidone for Rare Lung Disease

AIRare Disease
  • Qureight achieved a world-first breakthrough by using AI-powered synthetic control arms to replace human placebo groups in lung disease research, demonstrating significant clinical efficacy for Avalyn's inhaled pirfenidone (AP01) in treating idiopathic pulmonary fibrosis.
  • The innovative approach generated over 10,000 randomly sampled control groups from real-world IPF patient data, with results showing statistically significant reduction in lung capacity decline over 48 weeks compared to the 100mg AP01 dose.
  • This groundbreaking methodology addresses critical ethical and practical challenges in rare disease trials by reducing study costs, duration, and the need for placebo assignments in high-mortality conditions like IPF.
  • The technology leverages deep-learning analytics and quantitative image analysis to create digitally-twinned synthetic controls that more closely match treated patients' baseline disease states than traditional randomized placebo comparisons.

Formycon Launches €50 Million Corporate Bond to Accelerate Biosimilar Portfolio Development

Drug Approval
  • Formycon AG announced plans to issue a four-year corporate bond with a target volume of €50 million to fund the development and expansion of its biosimilar product portfolio.
  • The unsecured floating rate bond carries an interest rate based on three-month EURIBOR plus a 7.0% to 7.5% margin, with proceeds supporting the company's transition from development to commercial focus.
  • The public offering will be available in Germany, Luxembourg, and Austria, with subscription periods running from June 18-30, 2025, marking Formycon's first use of debt capital financing.
  • The company currently has three FDA and EMA-approved biosimilars including FYB201/ranibizumab already marketed in Europe and the USA, with four additional candidates in development targeting a biosimilar market projected to reach $74 billion by 2030.

BASF Opens New GMP Solution Center in Michigan to Strengthen Biopharma Manufacturing Capabilities

  • BASF opened a new Good Manufacturing Practice Solution Center in Wyandotte, Michigan on June 17, 2025, expanding its network of GMP sites for biopharma and pharmaceutical ingredient production.
  • The facility features state-of-the-art clean room packaging and high-sensitivity analytical testing capabilities that enable closer collaboration with customers on customized product development.
  • The new center offers unique production capabilities with tightly controlled parameters beyond compendial limits and validated control systems for high reproducibility in bioprocessing ingredients and excipients.

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