clinical trial

Vir Biotechnology’s VIR-5500, a novel T-cell engager for advanced prostate cancer, showed promising safety and anti-tumor activity in Phase 1 trials. The therapy demonstrated significant PSA declines and objective responses in heavily pre-treated patients, with manageable side effects. This dual-targeting approach, utilizing PRO-XTEN® masking, aims for a differentiated therapeutic index, potentially offering a new option for patients with limited treatment choices.

Stoke Therapeutics is accelerating its Dravet syndrome drug development, aiming for a mid-2027 NDA submission for zorevunersen. The company is collaborating with Biogen on this RNA medicine designed to address the root cause of the severe epilepsy by restoring a key protein. Positive Phase 3 enrollment is on track, and Stoke is actively engaging with the FDA to expedite the drug’s availability for patients with limited options. The company has sufficient funding to support operations through 2028.

Kezar Life Sciences secured an FDA meeting to discuss zetomipzomib for autoimmune hepatitis. The meeting will focus on designing a Phase 2b clinical study for relapsed and refractory AIH patients. Kezar provided pharmacokinetic and safety data, seeking to amend monitoring requirements and align on trial conduct. This move aims to advance zetomipzomib, a potential treatment for a serious condition with unmet needs.

HUTCHMED has advanced its pancreatic cancer program to Phase III, initiating a trial for a combination therapy of surufatinib, camrelizumab, nab-paclitaxel, and gemcitabine (S+C+AG) for metastatic PDAC in China. Promising Phase II results showed significant improvements in progression-free survival and objective response rate compared to the standard chemotherapy regimen. The Phase III trial will evaluate overall survival as the primary endpoint in approximately 400 additional patients.

Takeda’s oral TYK2 inhibitor, zasocitinib, demonstrated strong efficacy in Phase 3 psoriasis trials, meeting all primary and secondary endpoints. The drug achieved significant skin clearance, with many patients experiencing substantial improvement and complete skin clearance by week 16. Zasocitinib showed a consistent safety profile and is poised for regulatory submission in fiscal year 2026, offering a promising new oral treatment option for moderate-to-severe plaque psoriasis.

Nektar Therapeutics presented Phase 2b REZOLVE-AD data at ACAAI 2025, highlighting rezpegaldesleukin’s potential in atopic dermatitis and comorbid asthma. The study showed statistically significant reductions in Asthma Control Questionnaire (ACQ-5) scores in patients with both conditions. Notably, patients with poorly controlled asthma experienced even greater improvements. These findings suggest that rezpegaldesleukin, an IL-2 pathway agonist, may offer benefits beyond skin symptoms by promoting regulatory T-cell activity. Phase 3 trials are planned.

Phathom Pharmaceuticals’ VOQUEZNA (vonoprazan) demonstrated rapid and sustained relief of nocturnal GERD symptoms in a Phase 3 trial. Patients experienced significantly more heartburn-free nights compared to placebo, with symptom relief starting after the first dose and lasting through a 20-week extension. VOQUEZNA was generally well-tolerated, though the label includes postmarketing risks requiring monitoring. Some efficacy analyses were exploratory and not adjusted for multiple comparisons. VOQUEZNA is approved in the US for GERD and *H. pylori* treatment.

Corcept Therapeutics presented Phase 3 ROSELLA trial data at ESMO 2025, showing relacorilant plus nab-paclitaxel significantly improved progression-free and overall survival in platinum-resistant ovarian cancer patients, including those progressing on PARP inhibitors. The combination also demonstrated a favorable safety profile. Corcept is expanding the Phase 2 BELLA trial to include platinum-sensitive ovarian and endometrial cancer arms, with initial results expected in late 2026. The FDA has granted relacorilant priority review for platinum-resistant ovarian cancer with a PDUFA date of July 11, 2026.

Regeneron’s DB-OTO gene therapy showed significant hearing improvements in children with OTOF-related hearing loss in the CHORD trial. 11 of 12 participants demonstrated clinically meaningful hearing gains, with 3 achieving normal hearing. The trial met its primary endpoint, and improvements were durable up to 72 weeks. DB-OTO was generally well-tolerated. Regeneron plans to file for U.S. regulatory approval later in 2025, pending FDA discussions. DB-OTO holds Orphan Drug and other FDA designations.