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Clinical Trial News

Ignite Proteomics' RPPA Assay Drives Complete Response in HER2-Negative Breast Cancer

• Ignite Proteomics launches a novel precision oncology assay using Reverse Phase Protein Array (RPPA) technology for breast cancer treatment decisions. • A case study demonstrated a complete response in a metastatic triple-negative breast cancer patient treated with trastuzumab deruxtecan (T-DXd) after RPPA identified HER2 expression. • The RPPA assay uniquely measures both the expression and activated protein drug target levels in breast tumors, improving targeted therapy effectiveness. • This clinically validated assay represents a significant advancement in personalized oncology care, potentially impacting patient outcomes.

Antibody-Drug Conjugates for Cancer Show Promise with Multiple FDA Approvals Anticipated by 2027

  • The cancer antibody-drug conjugate (ADC) market is experiencing substantial growth, driven by the demand for targeted therapies that improve efficacy and reduce side effects.
  • Over 600 ADCs are currently in clinical trials, with more than 20 in Phase 3, indicating a robust pipeline of potential new cancer treatments.
  • Several ADC candidates are in late-stage clinical trials, targeting various malignancies, including lung, breast, and urogenital cancers.
  • ADCs combine monoclonal antibodies with cytotoxic agents, enabling targeted drug delivery to cancer cells, improving patient outcomes and diagnostic accuracy.

Traveler's Diarrhea Therapeutics: Pipeline Analysis Highlights Novel Approaches

  • A new report highlights the pipeline for Traveler's Diarrhea therapeutics, featuring over four companies developing novel treatments.
  • Immuron's IMM-124E, an oral polyclonal antibody therapy targeting LPS, is currently in Phase II clinical trials.
  • The pipeline includes drugs in various stages of development, from Phase III to discovery, with diverse routes of administration.
  • Key players like Immuron, Scandinavian Biopharma, and Sigmoid Pharma are exploring innovative approaches to address this condition.

Starton Therapeutics' On-Body Injector Successfully Delivers Lenalidomide for Cancer Treatment

  • Starton Therapeutics successfully used BD's on-body injector to deliver its low-dose lenalidomide formulation, STAR-LLD, offering continuous subcutaneous delivery.
  • A Phase Ib trial of STAR-LLD in multiple myeloma met its primary and secondary endpoints, showing promise compared to oral Revlimid (lenalidomide).
  • Starton plans to initiate larger Phase II trials in 2025 for chronic lymphocytic leukemia and multiple myeloma, expanding the potential use of STAR-LLD.
  • The on-body technology aims to improve the quality of life for patients by providing a more convenient and tolerable method of lenalidomide administration.

Newron's Evenamide Shows Promise in Treatment-Resistant Schizophrenia

  • Newron Pharmaceuticals reported positive results for evenamide in treatment-resistant schizophrenia (TRS) from Phase II trials, demonstrating significant improvements in symptoms.
  • Study 008A showed statistically significant benefits in PANSS and CGI-C ratings, suggesting potential for larger, enduring effects with long-term use of evenamide.
  • Newron is advancing evenamide to a Phase III trial, expected to begin in H1 2025, to further assess its efficacy and safety as an add-on treatment for TRS.
  • The company is actively seeking partnerships to support the Phase III development of evenamide and explore opportunities for collaboration to expand its CNS pipeline.

MDA Awards $500,000 Grant to HEALEY ALS Platform Trial at Mass General

• The Muscular Dystrophy Association (MDA) has awarded a $500,000 grant to Massachusetts General Hospital (MGH) to support the HEALEY ALS Platform Trial. • The HEALEY ALS Platform Trial aims to accelerate the development of effective treatments for amyotrophic lateral sclerosis (ALS) by testing multiple therapies simultaneously. • The grant will enhance patient outreach and recruitment, explore new biomarkers, and engage with the FDA to adapt the trial based on previous experience. • MDA's commitment to ALS research dates back to the 1950s, with over $176 million invested to date, supporting research, care, and advocacy for the ALS community.

Apnimed's AD109 Phase 3 Trial for Obstructive Sleep Apnea Completes Enrollment

  • Apnimed has completed enrollment for its Phase 3 SynAIRgy study evaluating AD109, a potential oral treatment for obstructive sleep apnea (OSA).
  • The SynAIRgy study assesses the efficacy and safety of AD109 compared to placebo over six months in adults with mild, moderate, and severe OSA.
  • AD109 targets the neuromuscular dysfunction underlying OSA, potentially offering a novel approach to improve oxygenation during sleep.
  • Topline Phase 3 data from both the SynAIRgy and LunAIRo studies of AD109 are expected in mid-2025.

Parallel-Arm Study to Compare AD109 to Placebo With Patients With OSA (SynAIRgy Study)

NCT05813275CompletedPhase 3
Apnimed
Posted 9/16/2023

COVID-19 Linked to Increased Risk of Chronic Fatigue Syndrome, Study Finds

  • A Kaiser Permanente study found that 14% of individuals with chronic fatigue-like syndrome developed it following a COVID-19 infection.
  • The research surveyed nearly 10,000 patients, estimating that 1.67% of Kaiser Permanente Northern California members had ME/CFS-like syndrome in 2022.
  • Patients who developed ME/CFS-like syndrome post-COVID were more likely to be unvaccinated and infected before June 2021.
  • The study highlights the significant impact of ME/CFS on physical, mental, and social functioning, with post-COVID patients experiencing greater anxiety.

AstraZeneca's Saphnelo Enters Phase III Trials for Cutaneous Lupus and Inflammatory Myopathies

  • AstraZeneca has initiated two new Phase III trials, LAVENDER and JASMINE, to evaluate Saphnelo (anifrolumab) in cutaneous lupus erythematosus (CLE) and idiopathic inflammatory myopathies (IIM), respectively.
  • The LAVENDER trial will assess Saphnelo's efficacy in reducing skin disease in approximately 460 adults with chronic and/or cutaneous lupus erythematosus.
  • The JASMINE trial will evaluate the efficacy and safety of subcutaneous Saphnelo in about 240 adults with moderate to severe idiopathic inflammatory myopathies.
  • These trials reflect AstraZeneca's focus on immune-mediated diseases and the potential of Saphnelo, a type I interferon receptor antagonist, in conditions with high unmet needs.

Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis

NCT05138133RecruitingPhase 3
AstraZeneca
Posted 2/15/2022

A 2-stage, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus

NCT06015737RecruitingPhase 3
AstraZeneca
Posted 6/29/2024

Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)

NCT05925803RecruitingPhase 3
AstraZeneca
Posted 11/8/2023

A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)

NCT06455449RecruitingPhase 3
AstraZeneca
Posted 6/20/2024

Multinational Pharmacogenomics Study in Africa Aims to Optimize Treatment Outcomes

  • Professor Collen Masimirembwa leads a multinational study across Nigeria, Kenya, Zimbabwe, and South Africa to explore how genes affect medication response.
  • The iPROTECTA protocol will test the clinical benefit of pharmacogenomics, using the GenoPharm genetic test to optimize treatments for sickle cell disease and gastro-intestinal tumors.
  • The study aims to address the gap in pharmacogenomics research and clinical implementation in the Global South, potentially improving treatment outcomes.
  • The African Institute of Biomedical Science and Technology (AiBST) contributes to genomics training and research, fostering drug development by African scientists.

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