clinical trial

Apogee Therapeutics will announce pivotal 16-week data from its Phase 2 APEX trial for APG777, a novel inflation drug. The data, expected on July 7, 2025, could reveal differentiated efficacy and new dosing regimens for conditions like atopic dermatitis, asthma, and COPD. The company will host a conference call to discuss the findings.

China is establishing national standards for non-invasive BCI medical devices, paralleling advancements in invasive BCI clinical trials. The BCI market is rapidly growing, with applications in healthcare, cognitive enhancement, and new human-computer interaction paradigms. Companies like Neuralink and Synchron are pushing boundaries, with widespread commercialization expected within five years. Micro-vision Holography is investing heavily in BCI, aiming to integrate it with robotics and quantum computing for diverse applications. BCIs are poised for significant growth and integration across multiple sectors.

Biogen released positive new data on its SMA treatment, SPINRAZA (nusinersen). Findings from the DEVOTE and NURTURE trials highlight the drug’s continued efficacy. The DEVOTE data suggests potential benefits from a higher dose regimen for previously treated patients, showing functional improvements across different patient groups. The final NURTURE study results reinforce the value of early intervention, demonstrating long-term benefits and safety. Biogen is awaiting regulatory approvals for the new higher dose regimen.

Innovent Biologics initiated a Phase 3 trial (GLORY-OSA) in China for mazdutide, a dual GCG and GLP-1 receptor agonist. The study will evaluate the drug’s efficacy and safety in Chinese patients with obesity and moderate-to-severe obstructive sleep apnea (OSA). Mazdutide has shown potential in weight loss and metabolic improvements, representing a potential treatment for a condition that affects millions in China, where current diagnosis rates are low. This marks the seventh Phase 3 study for the drug.

Phase 1b/2 trial data showed that epcoritamab combined with R-ICE achieved an 87% overall response rate and a 65% complete response rate in relapsed/refractory DLBCL patients, with 65% proceeding to ASCT. These results, presented at EHA, suggest epcoritamab may improve ASCT eligibility and represent a potential new treatment option.

Regeneron and Sanofi announced positive Phase 4 trial results for Dupixent in treating moderate-to-severe atopic dermatitis in adults and adolescents with skin of color. The DISCOVER trial, involving 120 patients, showed significant improvements in disease severity, itch reduction, and post-inflammatory hyperpigmentation. The safety profile aligned with previous findings. This marks a significant advancement in treating this often-underserved population.

Iovance Biotherapeutics announced five-year follow-up data for Amtagvi (lifileucel) in advanced melanoma. Results from the Phase 2 trial show deep, durable responses with one-third of patients maintaining ongoing responses after five years. Median overall survival was 13.9 months, with a five-year survival rate of 19.7%. The therapy, already FDA-approved, provides a new treatment option for patients with advanced melanoma who progressed after prior therapies.

Trevi Therapeutics will release topline results from its Phase 2b CORAL trial of Haduvio, an investigational therapy for chronic cough in idiopathic pulmonary fibrosis (IPF). A conference call and webcast will be held on June 2nd, 2025, at 8:30 a.m. ET to discuss the findings. Haduvio targets the cough reflex arc, and initial trials show promising reduction in cough frequency. The results are highly anticipated as there is currently no approved therapy for IPF chronic cough. Further information can be found on the company’s website.

Bicara Therapeutics presented positive Phase 1/1b trial data for ficerafusp alfa, a bifunctional antibody, combined with pembrolizumab in first-line recurrent/metastatic head and neck cancer. The results, particularly in HPV-negative patients, showed significant antitumor activity, including a median duration of response of 21.7 months, median overall survival of 21.3 months, and a two-year overall survival rate of 46%. The data supports the advancement of the FORTIFI-HN01 pivotal trial.

Innovent Biologics announced positive Phase 1/2 data for IBI363, a PD-1/IL-2α-bias bispecific antibody, at ASCO 2025. The study showed promising results in immunotherapy-resistant acral and mucosal melanoma (“cold tumors”), demonstrating a 23.3% confirmed objective response rate and 14.8 months median overall survival. A Phase 2 registration trial for IBI363 is underway, offering a potential breakthrough for advanced melanoma treatment.