MedPath

Clinical Trial News

Hypha Labs Advances AI-Powered Mushroom Cultivation Technology with New Patent Filings

AI
  • Hypha Labs filed four new patent applications with the USPTO to protect its AI-powered Mushroom Accelerator technology for functional mushroom cultivation.
  • The company's next-generation system uses artificial intelligence and cloud connectivity to optimize mycelium growth conditions including temperature, oxygen, and nutrient levels.
  • The patented technology includes modular cartridge systems designed for both home users and commercial-scale production of medicinal-grade mushroom ingredients.
  • The AI learning model analyzes real-time sensor data and successful harvest databases to provide automated optimization and over-the-air software updates.

Antibiotic Ciprofloxacin Shows Novel ACE Inhibition Mechanism, Opening Path to Improved Hypertension Therapies

Drug Discovery
  • UK and South African researchers discovered that the antibiotic ciprofloxacin blocks the ACE enzyme through a novel allosteric mechanism, binding to a different site than traditional ACE inhibitors.
  • The discovery offers potential for developing next-generation ACE inhibitors with fewer side effects, addressing limitations of current medications that affect multiple bodily processes.
  • While ciprofloxacin itself binds too weakly for therapeutic use, it serves as a template for designing more targeted cardiovascular drugs with improved safety profiles.
  • The research team plans to screen chemical analogues of ciprofloxacin to optimize binding and specificity for this new class of inhibitors.

Eli Health Raises $12M Series A to Commercialize Instant Saliva-Based Hormone Monitoring System

  • Canadian startup Eli Health secured $12 million in Series A funding led by BDC Capital's Thrive Venture Fund to advance its Hormometer™ technology for real-time hormone monitoring.
  • The Hormometer delivers instant hormone readings from saliva samples using smartphone integration, initially targeting cortisol monitoring with progesterone testing planned next.
  • The platform addresses a significant unmet need as an estimated 60% of adults experience hormonal imbalance symptoms, yet continuous monitoring remains largely inaccessible through traditional lab testing.
  • With FDA registration secured and in-house manufacturing established, the company plans public launch later this year with subscription pricing starting at $8 per test.

Network Meta-Analysis Reveals Comparable Cardiovascular Benefits Between PCSK9 Inhibitors Alirocumab and Evolocumab

  • A comprehensive network meta-analysis of 26 randomized controlled trials involving 64,921 patients found that alirocumab and evolocumab demonstrate comparable efficacy in reducing major cardiovascular events.
  • Both PCSK9 inhibitors significantly reduced the relative risk of major adverse cardiovascular events, myocardial infarction, stroke, and coronary revascularization compared to placebo.
  • While all-cause mortality rates were numerically lower for alirocumab compared to evolocumab, the difference was not statistically significant, and both drugs exhibited comparable safety profiles.

SIFI Merges with Faes Farma to Expand Global Access to Akantior, First Approved Therapy for Rare Eye Infection

Orphan DrugRare DiseaseDrug Approval
  • SIFI, a leading international ophthalmic company, has agreed to merge with European pharmaceutical company Faes Farma in a transaction that positions ophthalmology as approximately 20% of the combined entity's pro-forma revenue.
  • The merger will accelerate development of Akantior (polihexanide 0.08%), the first and only approved therapy worldwide for Acanthamoeba Keratitis, particularly targeting expansion into the US market where it has orphan drug designation.
  • The combined entity will leverage commercial synergies across complementary markets in Europe and Latin America, while also advancing polihexanide development for additional orphan indications including Fungal Keratitis.
  • The transaction values SIFI at a double-digit multiple of 2024 EBITDA plus regulatory and commercial milestone-based earn-outs, with closing expected in Q3 2025 subject to regulatory approvals.

US Universities Drive 87% of Academic Patents Supporting FDA Drug Approvals from 2020-2024

Drug Approval
  • US universities contributed patents supporting half of all FDA-approved drugs between 2020 and 2024, demonstrating their critical role in pharmaceutical innovation.
  • American academic institutions accounted for 87% of all university-based patents linked to FDA drug approvals during this four-year period.
  • The analysis examined patent data from the FDA's Orange Book, revealing the substantial impact of US-based research on global pharmaceutical development.
  • These findings underscore the prominence of American universities in driving medical treatment advances and pharmaceutical research efforts worldwide.

Semaglutide Demonstrates Safety and Efficacy for Weight Loss in Schizophrenia Patients

  • University of Queensland researchers conducted a 36-week trial showing semaglutide is safe and effective for weight loss in people with schizophrenia without affecting psychotic symptoms.
  • Study participants on semaglutide lost almost 14 percent of their bodyweight compared to placebo, with improved lean mass to fat mass ratio indicating preferential fat loss.
  • The findings provide world-first evidence addressing weight gain from antipsychotic medications, which contributes to a 16-year life expectancy gap in schizophrenia patients.
  • Researchers advocate for PBS listing of semaglutide for this population, as many patients cannot afford out-of-pocket costs for this treatment.

Nicoya Lifesciences Acquires Applied Photophysics to Create Integrated Biologics Characterization Platform

Drug Discovery
  • Nicoya Lifesciences has acquired UK-based Applied Photophysics, a 50-year-old provider of biophysical characterization instrumentation, to create a comprehensive biologics analysis platform.
  • The acquisition is expected to immediately double Nicoya's annual revenue, triple its customer base, and establish a foundation for 25% projected organic growth.
  • The combined platform integrates Surface Plasmon Resonance systems with Circular Dichroism, nanoDSF, and stopped-flow technologies to provide complete characterization of complex biologics from a single provider.
  • Applied Photophysics' UK headquarters will become Nicoya's European operational hub, significantly expanding the company's global reach and customer support capabilities.

Subcutaneous Mosunetuzumab Shows Promise in Untreated B-Cell Lymphomas with Durable Responses

  • Mosunetuzumab-axgb demonstrated a 77.8% overall response rate with 64% complete responses in previously untreated marginal zone lymphoma patients after 18.2 months median follow-up.
  • The subcutaneous formulation showed an 82.8% progression-free survival rate at 12 months in untreated high-tumor burden follicular lymphoma patients.
  • Safety profiles were manageable across both studies, with cytokine release syndrome occurring in about one-third of patients but remaining predominantly grade 1-2 severity.
  • Fixed-duration treatment regimens of 17 cycles showed durable responses, with median duration of response not reached in the marginal zone lymphoma cohort.

A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab Monotherapy in Participants With Select B-Cell Malignancies

NCT05207670Active, Not RecruitingPhase 2
Genentech, Inc.
Posted 2/1/2022

A Safety, Efficacy and Pharmacokinetic Study of BTCT4465A (Mosunetuzumab) as a Single Agent and Combined With Atezolizumab in Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

NCT02500407CompletedPhase 1
Genentech, Inc.
Posted 9/15/2015

Bexorg Partners with Biohaven to Advance CNS Drug Development Using AI-Driven Whole-Brain Discovery Platform

AI
  • Bexorg announced a multi-program research collaboration with Biohaven to identify and advance next-generation therapies for central nervous system disorders using its novel whole-brain discovery platform.
  • The platform represents the only technology capable of perfusing isolated human and pig brains with artificial blood to restore metabolic activity for prolonged periods, enabling unprecedented preclinical testing.
  • Bexorg's technology will support two preclinical development programs at Biohaven by demonstrating target engagement and generating biomarkers, pharmacokinetic data, and mechanistic insights.
  • The collaboration aims to overcome traditional translational gaps in CNS drug discovery by providing detailed insights into pharmacology and efficacy before advancing to clinical trials.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.