Acesion Pharma has begun enrolling patients into a phase 2 clinical trial of AP31969, its novel oral SK ion channel inhibitor being developed for rhythm control in atrial fibrillation.

The company said the first participants have now entered the randomised, double-blind, placebo-controlled study, which will recruit 200 patients across eight European countries and is expected to complete in the first quarter of 2027.

The trial’s primary efficacy endpoint is atrial fibrillation burden, defined as the percentage of time a participant spends in atrial fibrillation. A key safety measure is the occurrence of ventricular pro-arrhythmia, a major limitation of existing anti-arrhythmic drugs.

To support continuous assessment, all participants will receive an implantable loop recorder enabling round-the-clock cardiac rhythm monitoring.

Acesion recently completed a phase 1 study of AP31969 in 92 healthy volunteers. That trial assessed single and multiple ascending doses, pharmacokinetics and effects on the QT interval, an established marker of pro-arrhythmia risk.

According to the company, AP31969 showed a favourable safety profile and suitable pharmacokinetics for chronic oral dosing, and clinically relevant effects on QTc could be ruled out.

Anders Gaarsdal Holst, Chief Executive Officer of Acesion, said: “Advancing our oral lead compound AP31969 into a phase 2 clinical trial marks an important milestone for Acesion.”

HUTCHMED has advanced its ongoing study of surufatinib and camrelizumab for treatment naïve metastatic pancreatic ductal adenocarcinoma, initiating the phase 3 stage of its phase 2/3 trial in China. The company confirmed that the first patient received a dose on 30 December 2025.

Pancreatic ductal adenocarcinoma is the most common and aggressive form of pancreatic cancer, accounting for more than 90% of cases. Globally, around 511,000 people were diagnosed with pancreatic cancer in 2022 and approximately 467,000 died from the disease. Survival remains poor, with fewer than 10% of patients living five years after diagnosis.

In China, 119,000 cases and 106,000 deaths were recorded in 2022. Standard treatments such as chemotherapy, surgery and radiotherapy have delivered limited improvements, and fewer than one in five patients with metastatic disease survive beyond a year.

The multicentre, randomised, open label trial is comparing a four drug combination of surufatinib, camrelizumab, nab paclitaxel and gemcitabine with the established regimen of nab paclitaxel plus gemcitabine. Sixty-two patients were enrolled in the phase 2 portion, and the phase 3 stage aims to recruit around 400 more.

Overall survival is the primary endpoint, with secondary measures including progression-free survival, objective response rate, duration of response, disease control rate, quality of life and safety. The study is led by Professor Shukui Qin of China Pharmaceutical University Nanjing Tianyinshan Hospital and Professor Jihui Hao of Tianjin Medical University Cancer Institute and Hospital.