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KalVista Pharmaceuticals to Present at Cantor Global Healthcare Conference and Provides Regulatory Update for Sebetralstat

  • KalVista Pharmaceuticals will participate in a fireside chat at the 2024 Cantor Global Healthcare Conference on September 19, 2024, to discuss its clinical programs.
  • The FDA has accepted KalVista's NDA for sebetralstat, an oral, on-demand therapy for hereditary angioedema (HAE), with a PDUFA goal date of June 17, 2025.
  • The EMA validated KalVista's MAA for sebetralstat in August 2024, with plans to file for approval in the UK, Japan, and other countries later this year.

Dupixent Shows Clinically Meaningful Benefit in COPD Patients with Type 2 Inflammation

  • Pooled analysis of BOREAS and NOTUS phase 3 trials reveals Dupixent significantly reduced COPD exacerbations by 31% over 52 weeks.
  • Dupixent improved lung function (FEV1) by 147 mL compared to 64 mL with placebo at 12 weeks, with sustained benefits observed at 52 weeks.
  • The safety profile of Dupixent in this analysis was consistent with previous studies, supporting its use in COPD patients with type 2 inflammation.
  • Dupixent has been approved in the EU, Brazil and Russia for certain adults with uncontrolled COPD associated with type 2 inflammation.

Phase 2 Trial Assesses 99mTc-maraciclatide for ILD Prognosis

  • A Phase 2 study, PREDICT-ILD, has commenced to evaluate 99mTc-maraciclatide, a novel molecular imaging agent, for predicting interstitial lung disease (ILD) progression.
  • The study will compare 99mTc-maraciclatide uptake in patients with idiopathic pulmonary fibrosis (IPF) and non-IPF fibrosing-ILD, against healthy controls to assess its efficacy as a prognostic marker.
  • Researchers aim to determine if 99mTc-maraciclatide can identify αvβ3 activity and predict disease progression in patients with fibrosing ILD, potentially improving treatment strategies.
  • The PREDICT-ILD study, involving multiple NHS sites, seeks to address the urgent need for better diagnostic tools in managing unpredictable ILD progression.

PRospective Evaluation of Interstitial Lung DIsease Progression With Quantitative CT

NCT05609201Enrolling by Invitation
University of Exeter
Posted 6/1/2023

AstraZeneca's Datopotamab Deruxtecan Fails to Meet Overall Survival Endpoint in Phase 3 Breast Cancer Trial

  • AstraZeneca's datopotamab deruxtecan (Dato-DXd) did not achieve statistical significance in overall survival for breast cancer patients in a Phase 3 trial.
  • The trial involved over 700 patients with inoperable or metastatic hormone receptor-positive, HER2-low or negative breast cancer.
  • AstraZeneca plans to submit the data to regulatory agencies, despite the uncertain regulatory future of Dato-DXd after these results.

TC BioPharm to Explore Gamma Delta T-Cell Therapy TCB008 for Mpox Treatment

  • TC BioPharm is initiating preclinical studies for TCB008, an unmodified cell therapy, to treat Mpox, leveraging the role of gamma delta T-cells in viral infections.
  • TCB008, which contains activated and expanded gamma delta T cells, aims to prevent death, reduce viral infection duration, and potentially slow the spread of Mpox.
  • The company is also progressing with its ACHIEVE Phase 2b trial, evaluating TCB008 in AML or MDS/AML patients, and has secured a European patent for modified gamma delta cells.
  • TC BioPharm believes TCB008 could be a game-changing monotherapy for blood cancers, as reflected by strong enrollment and patient retention rates in the ACHIEVE Phase 2b trial.

Iruplinalkib Shows Sustained Benefit in Crizotinib-Resistant NSCLC

  • Updated data from the Phase II INTELLECT study reveals that iruplinalkib demonstrates a median overall survival of 41.79 months in NSCLC patients.
  • The study reported an objective response rate of 63.7% and a disease control rate of 94.5% with iruplinalkib in crizotinib-resistant NSCLC.
  • Iruplinalkib showed promising intracranial activity in patients with CNS metastasis, with an intracranial objective response rate of 64.3%.
  • The safety profile of iruplinalkib remains consistent, with no new safety signals identified in the extended follow-up.

MAIA Biotechnology's THIO Shows Promising Survival Benefit in Advanced NSCLC

  • MAIA Biotechnology's THIO, combined with cemiplimab, demonstrates a significant survival benefit in advanced NSCLC patients who failed prior therapies.
  • Interim data from the Phase 2 THIO-101 trial shows 16 patients surpassing 12-month survival, with a median follow-up of 10.6 months in third-line treatment.
  • The observed survival benefit with THIO surpasses the 5.8-month overall survival typically seen with standard-of-care in third-line NSCLC.
  • THIO targets telomeres, potentially overcoming resistance mechanisms and inducing cancer cell death, offering a novel approach to NSCLC treatment.

THIO Sequenced With Cemiplimab in Advanced NSCLC

NCT05208944RecruitingPhase 2
Maia Biotechnology
Posted 6/8/2022

Exosome Therapeutics and Diagnostics Pipeline Shows Promising Growth

  • The exosome market is experiencing rapid growth, driven by advancements in liquid biopsy, precision medicine, and regenerative medicine.
  • Over 70 companies are developing 75+ exosome-based therapies, with several candidates in various clinical trial phases.
  • Exosome-based diagnostics are gaining traction, with two products already receiving Fast Track approval from the U.S. FDA.
  • The first exosome therapeutics are anticipated by 2029, offering advantages like targeted delivery and reduced side effects.

Cognitive Behavioral Therapy Shows Promise for Menopausal Women's Libido

  • Cognitive behavioral therapy (CBT) significantly improved sexual desire and satisfaction in middle-aged and older women experiencing menopause.
  • The therapy led to improvements in body image, sexual satisfaction, and a reduction in menopause symptoms, depression, and anxiety.
  • Participants reported high satisfaction with the treatment, noting its effectiveness in managing menopause symptoms and improving overall well-being.
  • This study supports the use of CBT as a potential intervention for sexual concerns related to menopause and warrants further investigation in larger clinical trials.

FDA Advisory Committee Recommends Narrowing Sulopenem's Indication for UTI Treatment

  • FDA advisory committee suggests limiting sulopenem's use to patients with specific complicated urinary tract infections (cUTIs) where alternative treatments are limited.
  • The Antimicrobial Drugs Advisory Committee voted that the benefits of sulopenem outweigh the risks, but only for a restricted patient population.
  • Concerns were raised regarding the drug's broad-spectrum activity and potential for promoting antimicrobial resistance, influencing the committee's recommendation.
  • Iterum Therapeutics faces the challenge of aligning the drug's label with the FDA's requirements following the advisory committee's guidance.

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