Clinical Trial News
Swimming Microrobots Deliver Cancer-fighting Drugs to Metastatic Lung Tumors in Mice
Engineers at UC San Diego have developed microrobots that swim through the lungs to deliver cancer-fighting drugs directly to metastatic tumors in mice, showing promise in inhibiting tumor growth and spread, and boosting survival rates.
Positive Phase 2 Results for Setrusumab in Osteogenesis Imperfecta Treatment
Ultragenyx and Mereo BioPharma have announced promising 14-month results from the Phase 2 portion of the Phase 2/3 Orbit study, showing setrusumab significantly reduces fracture rates and improves bone mineral density in patients with Osteogenesis Imperfecta.
Highlighted Clinical Trials:
Ultragenyx Pharmaceutical Inc
Posted 2/21/2022
EHA 2024: Monoclonal Antibodies Show Promise in Multiple Myeloma Treatment
- The DREAMM-8 trial demonstrated that Blenrep combined with pomalidomide and dexamethasone significantly improved progression-free survival in relapsed/refractory multiple myeloma (RRMM) patients compared to pomalidomide, bortezomib, and dexamethasone.
- Linvoseltamab monotherapy in the LINKER-MM1 study showed substantial efficacy in RRMM patients, with a high objective response rate and durable responses, marking it as a promising treatment option.
- The GMMG-HD7 trial indicated that adding Sarclisa to standard-of-care induction therapy resulted in deeper responses and higher rates of minimal residual disease negativity in newly diagnosed multiple myeloma patients.
Highlighted Clinical Trials:
Dickran Kazandjian, MD
Posted 8/31/2024
Aldeyra Therapeutics Completes Enrollment in Phase III Dry Eye Disease Trial of Reproxalap
- Aldeyra Therapeutics has finished enrolling 132 subjects for its Phase III clinical trial evaluating topical ocular 0.25% reproxalap for dry eye disease.
- The trial assesses the primary endpoint of ocular discomfort to support a potential resubmission of a New Drug Application (NDA) in the second half of 2024.
- Reproxalap previously demonstrated a statistically significant reduction in ocular discomfort compared to a vehicle in combined data from four completed dry eye chamber trials.
- Aldeyra aims to propose a draft label highlighting both chronic and acute symptom improvement, along with a reduction in ocular redness, for reproxalap.
Verastem Oncology Announces Positive Interim Results and FDA Submission for Cancer Therapies
- Verastem Oncology reported an 83% overall response rate in a Phase 1/2 trial of avutometinib plus defactinib with chemotherapy for metastatic pancreatic cancer.
- The company initiated a rolling NDA submission to the FDA for avutometinib and defactinib in recurrent KRAS mutant low-grade serous ovarian cancer (LGSOC).
- A Phase 3 trial is underway comparing the combination therapy to standard chemotherapy or hormonal therapy for recurrent LGSOC.
FDA Approves Moderna's mResvia, Third RSV Vaccine for Older Adults
- The FDA has approved Moderna's mResvia vaccine for the prevention of RSV in adults aged 60 and older, making it the third approved RSV vaccine.
- mResvia, like Moderna's COVID-19 vaccine, utilizes mRNA technology to target the prefusion F protein of RSV, offering a prefilled syringe for easier administration.
- Moderna anticipates the RSV vaccine market to reach $6-8 billion in annual sales, with mResvia potentially gaining market share based on efficacy and ease of use.
- Clinical trials showed mResvia to be approximately 84% effective against RSV-related disease with two or more symptoms, with effectiveness waning to 63% after 8.6 months.
FDA Expands Approval for GSK's Arexvy RSV Vaccine to Adults Aged 50-59 at Increased Risk
- The FDA has approved GSK's Arexvy vaccine for adults aged 50-59 at increased risk of RSV, making it the first RSV vaccine for this population.
- This approval is based on Phase III trial data demonstrating non-inferior immune responses in the 50-59 age group compared to those 60 and older.
- Approximately 13 million adults in the U.S. aged 50-59 with underlying conditions such as COPD, asthma, heart failure, and diabetes could benefit.
- Regulatory applications for Arexvy's label expansion are under review in the EU, Japan, and other countries, with trials ongoing for adults aged 18-49.
Hormonal Gel Shows Promise in Phase 2 Trial for Male Contraception
- A phase 2 trial of a novel hormonal gel containing testosterone and Nestorone demonstrated 86% sperm suppression in men after 12 weeks of daily application.
- The gel's faster-than-expected action, achieving effective contraception in approximately eight weeks, is attributed to the combination of testosterone and Nestorone.
- Researchers are now evaluating the gel's efficacy in preventing pregnancy within committed, monogamous relationships, with couples using it as their sole contraceptive method.
- Several non-hormonal male contraceptive options are also in development, including pills and injectable gels, addressing the growing demand for diverse birth control choices.
MoonLake Immunotherapeutics Initiates Phase 3 VELA Program for Sonelokimab in Hidradenitis Suppurativa
- MoonLake Immunotherapeutics has commenced its Phase 3 VELA program to evaluate sonelokimab for moderate-to-severe hidradenitis suppurativa (HS).
- The VELA program consists of two identical trials, VELA-1 and VELA-2, enrolling 800 patients to assess the efficacy and safety of sonelokimab 120mg versus placebo.
- The primary endpoint for the VELA program is HiSCR75 at week 16, with topline results expected by mid-2025, potentially offering a new treatment option for HS patients.
- Sonelokimab, a Nanobody®, targets IL-17A/A, IL-17A/F, and IL-17F/F dimers, aiming to provide a more effective treatment for this debilitating chronic skin condition.
Highlighted Clinical Trials:
MoonLake Immunotherapeutics AG
Posted 12/13/2022
Bond Avillion 2 Development LP
Posted 7/31/2018
MoonLake Immunotherapeutics AG
Posted 5/15/2024
MoonLake Immunotherapeutics AG
Posted 4/25/2022
MoonLake Immunotherapeutics AG
Posted 5/14/2024
Novel Alzheimer's Therapies Show Promise in Slowing Disease Progression
- Remternetug demonstrates potential for faster amyloid clearance compared to existing immunotherapies, with ongoing Phase 3 trials evaluating subcutaneous administration.
- Buntanetap shows early promise in improving memory and reducing tau protein levels, with plans for a larger Phase 3 trial to confirm efficacy in early-stage Alzheimer's.
- Semaglutide, typically used for diabetes and weight loss, is under investigation for its potential to improve insulin sensitivity in the brain and slow Alzheimer's progression.
- These drugs are currently experimental and not yet available on the NHS, pending regulatory approval and cost-effectiveness evaluations.