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Doxycycline Prophylaxis Shows Promise in Preventing Bacterial STIs

  • A meta-analysis of six studies indicates that doxycycline prophylaxis (doxy-PrEP/PEP) significantly reduces the incidence of bacterial sexually transmitted infections (STIs).
  • Doxy-PEP was found to reduce the overall STI incidence by 60% among men who have sex with men (MSM) and transgender women (TGW).
  • The study showed Doxy-PEP significantly reduced new cases of chlamydia and syphilis, and is potentially effective against gonorrhea.
  • No serious adverse events were reported, suggesting that doxycycline prophylaxis is a safe and promising tool for bacterial STI prevention in high-risk populations.

Novartis' IAG933 Shows Promise in Advanced Solid Tumors with Specific Genetic Alterations

• A Phase I study evaluates IAG933, a TEAD inhibitor, in patients with advanced mesothelioma or other solid tumors harboring NF2/LATS1/LATS2 alterations or YAP/TAZ fusions. • The trial includes dose escalation and expansion phases to assess safety, tolerability, pharmacokinetics, and preliminary efficacy of IAG933. • Enrollment focuses on patients who have exhausted standard therapies, are ineligible for them, or lack standard treatment options, indicating a high unmet need. • The study mandates tumor biopsies to monitor treatment response and explore potential biomarkers, enhancing understanding of IAG933's mechanism.

Sapience Therapeutics Doses First Patient in Phase 2 Trial of ST316 for Colorectal Cancer

  • Sapience Therapeutics has dosed the first patient in its Phase 2 dose expansion study of ST316, a first-in-class β-catenin antagonist, for colorectal cancer.
  • The Phase 2 trial will evaluate ST316 in combination with standard of care treatments across multiple lines of therapy for CRC patients.
  • ST316 is designed to selectively inhibit the Wnt/β-catenin signaling pathway in tumor cells, offering a targeted approach to cancer treatment.
  • The trial follows promising Phase 1 results demonstrating ST316's potential as an effective therapy for Wnt pathway-driven cancers with a favorable safety profile.

A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors

NCT05848739RecruitingPhase 1
Sapience Therapeutics
Posted 6/5/2023

Sonrotoclax Plus Dexamethasone Shows Promise in Relapsed/Refractory Multiple Myeloma

• The combination of sonrotoclax and dexamethasone demonstrated a 75% overall response rate in heavily pretreated patients with relapsed/refractory multiple myeloma. • Notably, 50% of patients achieved very good partial responses or better, with 21% experiencing complete or stringent complete responses. • The median duration of response was 8 months, with some patients showing improvement beyond their initial response and remaining on treatment for over a year. • The combination was generally well-tolerated, though most patients experienced treatment-emergent adverse events, and the study is ongoing to explore other combinations.

A Phase 1b/2 Study of BGB-11417 as Monotherapy and in Various Combinations with Dexamethasone plus Carfilzomib, Dexamethasone plus Daratumumab, and Dexamethasone plus Pomalidomide in Multiple Myeloma

2023-507751-30-00RecruitingPhase 1/2
Beigene Ltd.

CLINUVEL Seeks Canadian Approval for SCENESSE® in Erythropoietic Protoporphyria

  • CLINUVEL has submitted a New Drug Submission to Health Canada for SCENESSE® (afamelanotide) to prevent phototoxicity in adults with erythropoietic protoporphyria (EPP).
  • SCENESSE®, if approved, would be the first treatment option available for EPP patients in Canada, addressing a significant unmet medical need.
  • The submission includes data from previous FDA approvals and long-term follow-up studies, demonstrating the drug's efficacy and safety profile.
  • Two Canadian specialty centers are already trained to administer SCENESSE®, with more identified to ensure prompt treatment access pending approvals.

Hypofractionated Radiotherapy Non-Inferior to Standard After Mastectomy in Breast Cancer

  • A phase 3 trial (RT CHARM) revealed hypofractionated postmastectomy radiotherapy is non-inferior to standard radiation regarding reconstruction complications.
  • The study found no significant difference in local and local regional recurrence rates between hypofractionated and conventional PMRT arms.
  • Hypofractionated PMRT could become the new standard, potentially improving the lives of breast cancer patients requiring post-mastectomy radiation.

Hypofractionated Radiation Therapy After Mastectomy in Preventing Recurrence in Patients with Stage IIa-IIIa Breast Cancer

NCT03414970Active, Not RecruitingPhase 3
Alliance for Clinical Trials in Oncology
Posted 3/12/2018

Hypofractionated Vs Conventional Fractionated Postmastectomy Radiotherapy for High Risk Breast Cancer

NCT03856372RecruitingNot Applicable
Fudan University
Posted 9/1/2018

RedHill Biopharma Secures U.S. Patent for Opaganib Biomarker in COVID-19 Treatment

  • RedHill Biopharma received a U.S. patent for identifying a novel biomarker (≤60% FiO2) to predict opaganib's efficacy in treating COVID-19, valid until 2041.
  • Post-hoc analysis of Phase 2/3 data showed opaganib improved outcomes in patients with ≤60% FiO2, including reduced need for oxygen and ventilation.
  • Opaganib, a host-directed SPHK2 inhibitor, is being developed for oncology, viral infections, inflammatory diseases, and nuclear/radioprotection.
  • The new patent strengthens opaganib's intellectual property portfolio, supporting its potential as a broad-acting therapeutic for various indications.

BridgeBio Pharma's Acoramidis Shows Promise in Transthyretin Cardiomyopathy Trial

• A post-hoc analysis of BridgeBio Pharma's Phase 3 ATTRibute-CM study highlights acoramidis' potential in treating transthyretin cardiomyopathy. • The analysis demonstrated significant reductions in all-cause mortality and cardiovascular-related hospitalizations with acoramidis. • An upcoming FDA decision on acoramidis is anticipated, potentially marking a significant milestone for BridgeBio Pharma. • H.C. Wainwright analyst Ram Selvaraju reiterated a Buy rating on BridgeBio Pharma with a price target of $43.00.

CARVYKTI Demonstrates Significant Survival Benefit in Relapsed/Refractory Multiple Myeloma

  • Phase III CARTITUDE-4 data shows CARVYKTI reduced the risk of death by 45% compared to PVd/DPd in relapsed or refractory multiple myeloma patients.
  • At 30 months, 76% of patients treated with CARVYKTI were alive, compared to 64% on alternative treatments, demonstrating a significant improvement in survival.
  • Analysts predict CARVYKTI revenues will reach $918 million this year and nearly double to $1.75 billion by 2025, driven by increased supply and strong demand.

Investigational Oral Medication Offers New Hope for Treatment-Resistant Depression

  • A clinical research study is evaluating a novel oral medication for individuals with depression who have not responded adequately to existing antidepressant treatments.
  • The investigational drug is designed to be used in conjunction with a patient's current antidepressant regimen, potentially enhancing therapeutic efficacy.
  • The study aims to provide an alternative treatment option for those struggling with persistent depression despite ongoing medication use.
  • Researchers are actively recruiting participants who are currently taking antidepressants but continue to experience depressive symptoms.

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