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ARPA-H Awards $27M to Phare Bio for AI-Powered Antibiotic Discovery Platform

  • Phare Bio secures $27 million in ARPA-H funding to advance its AI-driven drug discovery platform, focusing on developing novel antibiotic classes to combat antimicrobial resistance.
  • The company, partnering with MIT's Collins Lab and Harvard's Wyss Institute, will generate millions of training data points and create the first open-source database for AI-based antibiotic discovery.
  • The initiative aims to develop 15 new AI-generated preclinical antibiotic candidates and implement ten new filters for targeting specific bacterial infections including pneumonia and drug-resistant UTIs.

Union Therapeutics Advances Orismilast to Phase III for Atopic Dermatitis After Positive Phase IIb Results

  • Union Therapeutics plans to initiate a Phase III trial for orismilast in atopic dermatitis following successful Phase IIb results.
  • The Phase IIb ADESOS trial demonstrated a significant reduction in eczema area and severity index (EASI) scores with orismilast.
  • Orismilast, a PDE4 inhibitor, showed promising results across multiple inflammatory indications, including psoriasis and hidradenitis suppurativa.
  • The treatment groups also experienced a notable reduction in CCL17/TARC skin levels, a key biomarker for atopic dermatitis.

Study to Assess the Efficacy and Safety of Orismilast in Atopic Dermatitis (ADESOS)

NCT05469464CompletedPhase 2
UNION therapeutics
Posted 7/11/2022

Biocon Partners with Tabuk to Launch GLP-1 Therapies Across Middle East Markets

  • Biocon and Tabuk Pharmaceuticals have formed a strategic partnership to commercialize GLP-1 products for diabetes and weight management in Middle Eastern markets, with Biocon handling development and manufacturing.
  • Tabuk Pharmaceuticals will manage regional marketing authorizations, product registration, and promotional activities, with potential for future local manufacturing through technology transfer.
  • The collaboration aligns with Saudi Arabia's Vision 2030, aiming to localize specialty pharmaceutical production while addressing growing regional demand for diabetes and weight management therapies.

Surufatinib and Toripalimab Combination Shows Promise in Extensive-Stage Small Cell Lung Cancer

  • A phase Ib/II study reveals that surufatinib combined with toripalimab, etoposide, and cisplatin demonstrates a high objective response rate (ORR) of 97.1% in ES-SCLC patients.
  • The median progression-free survival (mPFS) reached 6.9 months, and the median overall survival (mOS) was 21.1 months, indicating a potential survival benefit.
  • Common treatment-related adverse events included anemia, proteinuria, and decreased white blood cell count, but no unexpected safety signals were observed.
  • Biomarker analysis suggests that low levels of serum neuron specific enolase (NSE) and pro-gastrin-releasing peptide (ProGRP) are associated with longer overall survival.

AbbVie Seeks FDA Approval for Telisotuzumab Vedotin in Advanced NSCLC

  • AbbVie has submitted a Biologics License Application to the FDA for telisotuzumab vedotin (Teliso-V) to treat non-small cell lung cancer.
  • The application targets patients with previously treated, locally advanced or metastatic EGFR wild type, nonsquamous NSCLC with c-Met protein overexpression.
  • The submission is supported by Phase 2 LUMINOSITY trial data, with ongoing Phase 3 trials further evaluating Teliso-V's efficacy.
  • Teliso-V, a first-in-class antibody-drug conjugate, aims to address the unmet needs of NSCLC patients with limited treatment options.

MRI Biomarkers Show Promise in Predicting Treatment Response in MASH, Reducing Need for Biopsies

  • New research validates quantitative MRI imaging as a reliable alternative to liver biopsies for assessing disease and monitoring treatment response in MASH patients.
  • A reduction of 80ms in cT1, measured by Perspectum's LiverMultiScan, predicts histological response to MASH therapies, offering a non-invasive biomarker for clinical trials.
  • The studies highlight the potential of non-invasive tests (NITs) to track liver health changes, potentially reducing reliance on invasive liver biopsies in MASH drug development.
  • Perspectum's LiverMultiScan, an FDA-cleared technology, offers a comprehensive assessment of liver health by quantifying disease activity, severity, fat, and iron content.

Cassava Sciences Faces Scrutiny as Simufilam Phase III Trials Continue Amidst Data Manipulation Allegations

  • Cassava Sciences is proceeding with Phase III trials of simufilam despite a $40 million SEC settlement for allegedly misleading data from a Phase IIb trial.
  • The SEC alleges that a consultant manipulated Phase IIb trial data to show 'dramatic improvements' in Alzheimer's markers, and that Cassava misled investors about blinded trial conditions.
  • Experts question the ethics and validity of continuing Phase III trials based on potentially fraudulent data, raising concerns about patient safety and public trust.
  • The FDA's scrutiny of simufilam's efficacy and data veracity is expected to be heightened, though approval may still be possible if trials demonstrate independently verified efficacy.

PTI-125 for Mild-to-moderate Alzheimer's Disease Patients

NCT04079803CompletedPhase 2
Cassava Sciences, Inc.
Posted 9/9/2019

Simufilam 50 mg or 100 mg for Mild-to-Moderate Alzheimer's Disease

NCT05026177TerminatedPhase 3
Cassava Sciences, Inc.
Posted 11/18/2021

Simufilam 100 mg for Mild-to-Moderate Alzheimer's Disease

NCT04994483CompletedPhase 3
Cassava Sciences, Inc.
Posted 11/3/2021

Bristol Myers Squibb and 2seventy bio Discontinue Enrollment in Phase 3 KarMMa-9 Trial for Abecma in Newly Diagnosed Multiple Myeloma

  • Bristol Myers Squibb and 2seventy bio halted enrollment in the Phase 3 KarMMa-9 trial evaluating Abecma (idecabtagene vicleucel) plus lenalidomide maintenance versus lenalidomide alone in newly diagnosed multiple myeloma (NDMM) patients.
  • The decision was driven by challenges in patient enrollment due to the evolving treatment landscape, where more intense induction therapies result in fewer eligible patients for the trial.
  • Advances in induction therapies now lead to complete responses or better in over 70% of NDMM patients post-transplant, reducing the eligible population for KarMMa-9, which aimed for patients with suboptimal responses.
  • Both companies will collaborate with investigators to determine the next steps for patients already participating in the KarMMa-9 study, while reaffirming their commitment to Abecma in multiple myeloma treatment.

An Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With High-Risk Multiple Myeloma

NCT03601078Active, Not RecruitingPhase 2
Celgene
Posted 12/13/2018

Efficacy and Safety Study of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)

NCT03651128Active, Not RecruitingPhase 3
Celgene
Posted 4/16/2019

A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation

NCT06045806Active, Not RecruitingPhase 3
Celgene
Posted 10/16/2023

Establishment Labs Gains FDA Approval for Motiva Breast Implants

  • Establishment Labs has received FDA approval for its Motiva SmoothSilk Ergonomix and Round breast implants for primary and revision augmentation.
  • The Motiva implants feature a patented SmoothSilk surface, designed to enhance biocompatibility and promote low inflammation.
  • Clinical trials showed less than 1% rates of capsular contracture and rupture with Motiva implants, demonstrating their safety and effectiveness.
  • Nearly four million Motiva devices have been delivered globally since 2010, marking a significant milestone for Establishment Labs.

Triple-Tracer PET Imaging Reveals High Intrapatient Heterogeneity in Metastatic Prostate Cancer

  • A multi-center study using triple-tracer PET imaging (18F-FDG, 68Ga-PSMA, 68Ga-DOTATATE) reveals high intrapatient intermetastatic heterogeneity (IIH) in mCRPC patients.
  • IIH was observed in 82.7% of patients, with 45.9% showing at least one 18F-FDG-positive/68Ga-PSMA-negative lesion, suggesting potential neuroendocrine differentiation.
  • Patients with IIH exhibited significantly shorter overall survival (9.5 months) compared to those without IIH, highlighting the clinical impact of tumor heterogeneity.
  • Based on imaging criteria, 53.1% of participants were eligible for PSMA-targeted radiopharmaceutical therapy, emphasizing the role of PET imaging in treatment stratification.

3TMPO (Triple-Tracer Strategy Against Metastatic Prostate Cancer

NCT04000776Completed
Université de Sherbrooke
Posted 12/16/2019

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