Clinical Trial News

Prota Therapeutics' long-term peanut allergy study published in Allergy confirms clinical remission as the optimal treatment outcome, with high-dose oral immunotherapies PRT120 and PRT100 showing lasting benefits, including improved quality of life and reduced allergic reactions.

Tempest Therapeutics announces positive FDA feedback for amezalpat (TPST-1120) in treating first-line hepatocellular carcinoma, with agreement on Phase 3 study design and endpoints.

FDA approves Niktimvo (axatilimab-csfr), an anti-CSF-1R antibody, for treating chronic graft-versus-host disease (GVHD) after failure of at least two prior therapies in adult and pediatric patients weighing at least 40 kg.

FDA grants accelerated approval for Livdelzi (seladelpar) for treating primary biliary cholangitis (PBC) in adults, either with ursodeoxycholic acid (UDCA) for inadequate response or as monotherapy for those unable to tolerate UDCA. The approval is based on a Phase 3 study showing 62% of Livdelzi-treated participants achieved a composite biochemical response at month 12, compared to 20% on placebo. Livdelzi led to ALP normalization in 25% of participants, a significant reduction in pruritus, and no treatment-related serious adverse events.

A new approach to cancer therapy involves stressing tumor cells with an activator, LB-100, then eliminating them with a WEE1 inhibitor, adavosertib. This 'paradoxical intervention' worked well in mice and is set for a phase 1b clinical trial for advanced colorectal cancer.

Accutar Biotechnology receives FDA Fast Track designation for AC699 in ER+/HER2- breast cancer. AC699, an AI-enabled drug, targets ESR1-mutated advanced or metastatic breast cancer, showing a 50% objective response rate in Phase 1 trials.

An experimental malaria vaccine, tested in Malian adults, showed sustained protection against parasite infection and clinical malaria over two years without a booster dose. It also significantly protected women from malaria during pregnancy, suggesting potential for improved prevention strategies.

UroGen Pharma Ltd. submitted the NDA for UGN-102 (mitomycin) for intravesical solution, aiming to treat low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The NDA is supported by the Phase 3 ENVISION study, which showed a 79.6% complete response rate at three months and an 82.3% 12-month duration of response. UroGen anticipates FDA approval in early 2025, potentially offering an alternative to repeated surgeries.

NeuroBo Pharmaceuticals completed enrollment for Phase 1 clinical trial of DA-1726, a dual oxyntomodulin analog agonist for obesity treatment, with 45 participants in 5 cohorts. The trial aims to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of DA-1726. Top-line data from the trial's SAD Part 1 is expected in Q3 2024, and from MAD Part 2 in Q1 2025. DA-1726 showed superior weight loss in pre-clinical data compared to other drugs, potentially positioning it as a best-in-class obesity drug.

FDA approves Nemluvio (nemolizumab) for treating adult patients with prurigo nodularis, based on positive results from the phase III OLYMPIA trials, demonstrating significant improvements in itch and skin nodules.