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Clinical Trial News

Merck Halts Phase 3 HYPERION Trial of Winrevair Early After Positive ZENITH Results

  • Merck's Phase 3 HYPERION trial of Winrevair (sotatercept) for pulmonary arterial hypertension (PAH) is stopped early due to positive results from the ZENITH trial.
  • The decision, made with the FDA and a steering committee, allows all HYPERION participants access to Winrevair in the SOTERIA extension study.
  • Winrevair, already approved in the U.S. and 38 countries, showed significant efficacy in the STELLAR and ZENITH trials, leading to the HYPERION halt.
  • HYPERION findings will be available later this year, adding to the growing evidence supporting Winrevair's role in PAH treatment.

Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13)

NCT04811092CompletedPhase 3
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Posted 3/18/2022

A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension

NCT03738150CompletedPhase 2
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Posted 4/19/2019

A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH)

NCT03496207CompletedPhase 2
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Posted 6/13/2018

A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH)

NCT04896008CompletedPhase 3
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Posted 12/1/2021

A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR)

NCT04576988CompletedPhase 3
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Posted 1/25/2021

A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12)

NCT04796337Active, Not RecruitingPhase 3
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Posted 5/12/2021

Eton Pharmaceuticals Acquires U.S. Rights to Amglidia for Neonatal Diabetes

• Eton Pharmaceuticals has acquired U.S. rights to Amglidia (glyburide oral suspension) from AMMTeK for treating neonatal diabetes mellitus. • Amglidia, already EMA-approved and available in Europe, addresses the unmet need for an FDA-approved oral treatment for this rare condition. • Eton plans to meet with the FDA in early 2025 and anticipates submitting an NDA for Amglidia in 2026, leveraging existing European safety and efficacy data. • The acquisition aligns with Eton's focus on pediatric endocrinology and expands its portfolio of treatments for rare diseases.

Merck's Winrevair Meets Primary Endpoint in Phase 3 ZENITH Trial for Pulmonary Arterial Hypertension

  • Merck's WINREVAIR (sotatercept-csrk) significantly reduced the risk of morbidity or mortality events in PAH patients in the Phase 3 ZENITH trial.
  • The ZENITH study was stopped early due to overwhelming efficacy, and participants will be offered WINREVAIR in an open-label extension study.
  • WINREVAIR, an activin signaling inhibitor, targets an underlying cause of PAH and has the potential to be practice-changing.
  • The drug is already approved in the U.S. and 36 other countries based on the Phase 3 STELLAR trial results.

A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH)

NCT04896008CompletedPhase 3
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Posted 12/1/2021

A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12)

NCT04796337Active, Not RecruitingPhase 3
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Posted 5/12/2021

NLRP3 Inflammasome Inhibition May Prevent Melanoma Hyper-Progression During Immunotherapy

  • Researchers have identified the NLRP3 inflammasome as a key driver of hyper-progression in melanoma patients treated with checkpoint inhibitors.
  • High baseline levels of inflammasome-related molecules in tumor tissue correlate with increased hyper-progression and reduced survival rates.
  • A potential therapeutic strategy involves inhibiting the NLRP3 inflammasome to overcome resistance to checkpoint inhibitor immunotherapy.
  • Clinical trials are underway to test NLRP3 inflammasome inhibitors in patients with checkpoint inhibitor-resistant tumors.

Superpulse Thulium Fiber Laser Shows Promise in Ureteroscopic Lithotripsy: A Randomized Trial

  • A randomized controlled trial is underway comparing superpulse thulium fiber laser (SPTL) to holmium laser lithotripsy for treating upper urinary tract stones.
  • The study aims to evaluate the clinical efficacy and safety of SPTL, focusing on stone-free rate, operative time, and complication rates.
  • The trial incorporates rigorous data monitoring and adverse event reporting to ensure patient safety and data integrity.
  • Statistical analysis will include chi-square tests, t-tests, and Wilcoxon rank sum tests, with multiple imputation used to manage missing data.

Levothyroxine Use Linked to Bone Density Loss in Older Adults with Normal Thyroid Function

  • A new study reveals that levothyroxine use is associated with bone density loss in older adults, even when thyroid function is within the normal range.
  • The research included 81 levothyroxine users and 364 non-users, with a median age of 73, monitored over a median of 6.3 years.
  • Findings suggest a need for careful risk-benefit assessment of levothyroxine treatment in older adults, considering potential adverse effects on bone health.
  • Regular monitoring of thyroid function is recommended for individuals taking levothyroxine to mitigate potential bone loss.

SCG101 Shows Promise in Phase I Trial for HBV-Related Hepatocellular Carcinoma

• SCG101, an autologous HBV-specific TCR-T cell therapy, demonstrated substantial antiviral activity in patients with advanced HBV-related hepatocellular carcinoma. • In a Phase I trial, 92% of subjects experienced a significant decrease in serum HBsAg levels, with some achieving complete HBsAg loss within 21 days. • The therapy was generally well-tolerated, with adverse events consistent with the targeted immune activation and clearance of diseased cells. • SCG101 has received trial approvals from regulatory bodies including the China NMPA, the US FDA, the Hong Kong DOH, and the Singapore HSA.

FDA Approves Zanidatamab (Ziihera) as First HER2-Targeted Bispecific Antibody for Biliary Tract Cancer

• The FDA granted accelerated approval to zanidatamab (Ziihera) for HER2-positive biliary tract cancer (BTC), marking it the first dual HER2-targeted bispecific antibody approved for this indication. • Approval was based on the HERIZON-BTC-01 trial, which showed a 52% objective response rate and a 14.9-month median duration of response in previously treated patients. • Zanidatamab's approval highlights the increasing role of bispecific antibodies in oncology, offering a novel approach to target cancer cells more precisely and effectively. • Continued approval may be contingent on confirmatory trials, including the Phase 3 HERIZON-BTC-302 trial, evaluating zanidatamab in combination with standard-of-care therapy.

Cysteamine Ophthalmic Solution Shows Promise in Japanese Cystinosis Patients

  • A Phase III study in Japan evaluated cysteamine hydrochloride 0.55% ophthalmic solution for treating corneal cystine crystals in cystinosis patients.
  • The study showed a decrease in corneal crystal density and improvement in photophobia, suggesting potential efficacy in Japanese patients.
  • The ophthalmic solution demonstrated an acceptable safety profile, with most adverse events being eye-related and manageable.
  • These findings support the use of cysteamine eye drops for managing ocular manifestations of cystinosis, a rare genetic disorder.

Peer Education Improves Medication Adherence and Cost-Effectiveness in Elderly Hypertensive Patients

  • A randomized clinical trial demonstrated that peer-led education significantly improved medication adherence among elderly patients with hypertension.
  • The study involved 74 participants and compared peer-led sessions to traditional nurse-led education, both based on Ministry of Health guidelines.
  • Cost-effectiveness analysis revealed that peer education was a more efficient method for enhancing medication adherence in this population.
  • The findings suggest peer education as a valuable strategy for hypertension management in elderly patients, offering both clinical and economic benefits.

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