Clinical Trial News

Dupixent showed significant improvements in disease remission and symptoms in bullous pemphigoid, meeting primary and secondary endpoints, with five times more patients achieving remission compared to placebo. It's the first medicine to show a significant steroid-sparing effect and could be the first targeted treatment for BP in the U.S. and EU if approved.

Piflufolastat (18F) (Pylclari) is now available in Spain for PSMA-positive lesion detection in prostate cancer patients, produced at Curium facilities in Madrid and Sevilla. It is indicated for high-risk prostate cancer staging and recurrence localization based on increasing serum PSA levels. The agent has been approved in the EU since July 2023 and in the US since May 2021, with high specificity, sensitivity, and positive predictive value demonstrated in phase 3 trials.

Centessa Pharmaceuticals plans to rapidly advance its experimental drug after a small study showed significant increase in time to sleep in healthy volunteers. The company intends to start mid-stage studies by year-end, evaluating the drug against narcolepsy and idiopathic hypersomnia. Centessa's CEO, Saurabh Saha, noted the data exceeded expectations, leading to accelerated development. The drug targets orexin proteins, with potential for a 1 mg, once-daily treatment, comparing favorably to Takeda's candidate. The study used Maintenance of Wakefulness Tests, showing the drug restored normative wakefulness with favorable safety and tolerability.

A phase 1 study on Amycretin, a once-a-day weight loss tablet combining GLP-1 and amylin receptors agonists, presented at EASD showed weight reduction and mild to moderate gastrointestinal side effects. Experts highlight the potential of oral medications for obesity treatment, though larger trials are needed to assess long-term effects and compare with injectable drugs.

Roche Holding AG remains unconcerned about side effects in a small study of its weight-loss shot CT-388, despite shares tumbling due to early release of side effect details. The company emphasizes no patients stopped treatment in the trial, and its other weight-loss candidate, CT-966, could be 'best in class.' Roche is focusing on five core therapy areas and diversifying in oncology, actively seeking partners in promising fields like antibody-drug conjugates.

A late-stage clinical trial showed liraglutide, similar to Ozempic, reduced BMI in kids ages 6-11 with obesity, with concerns about long-term safety and impact on growth. The trial included 82 children, with liraglutide resulting in a 5.8% average BMI reduction compared to a 1.6% increase in the placebo group. Novo Nordisk has applied to the FDA for approval of liraglutide for weight loss in this age group.

Novo Nordisk's experimental weight-loss pill amycretin showed safe and tolerable results in an early-stage trial, with participants losing up to 13.1% of their weight after 12 weeks, primarily experiencing mild-to-moderate gastrointestinal side effects.

Skyhawk Therapeutics announced positive Phase 1 trial results for SKY-0515, showing a 72% reduction in HTT mRNA at a 9mg dose, well-tolerated in healthy volunteers. Part C, enrolling Huntington's patients, expects topline data by Q2 2025. SKY-0515 targets HTT and PMS1 proteins, key in Huntington's disease.

Telix Pharmaceuticals announces primary results from Phase III ZIRCON trial, published in The Lancet Oncology, showing TLX250-CDx (Zircaix®) is highly accurate in detecting clear cell renal cell carcinoma (ccRCC) in patients with indeterminate renal masses (IRMs), with a favourable safety profile and potential to be practice-changing.

The 8 mg dexamethasone pre-medication regimen reduced infusion-related reaction (IRR) rates with intravenous amivantamab to 22.5%, a three-fold decrease from historical 67.4% rates.