November 2025 • PharmaTimes Magazine • 8

// CLINICAL TRIALS //


Orexa reports promising results in post-operative recovery trial

Orexa, a life sciences company based in the Netherlands, has announced positive interim results from its ongoing phase 2 trial investigating ORE-001 for the prevention of post-operative ileus (POI) in patients undergoing major abdominal surgery.

The multicentre, double-blind, placebo-controlled study is being conducted in Germany and led by Prof Alexander Mustea from Universitätsklinikum Bonn. It is enrolling up to 120 female patients undergoing gynaecological surgery requiring longitudinal laparotomy.

Following the randomisation of 40 patients, interim data revealed significant improvements in key recovery metrics for those receiving ORE-001.

Patients consumed 63% more lunch post-operatively compared to placebo, experienced their first stool approximately one day earlier and showed a marked reduction in gastrointestinal dysfunction, with incidence falling from 21% to 6%.  Additionally, the proportion of patients requiring extended hospitalisation due to adverse events dropped from 31% to 7%.

Prof Ard Peeters, CEO of Orexa, said: “This is a remarkable outcome for a vulnerable patient population. ORE-001 not only enhances patient well-being, but also has the potential to substantially reduce healthcare costs through faster recovery and shorter hospital stays.”

Prof Alexander Mustea, Principal Investigator at Universitätsklinikum Bonn, explained: “The early data from this study are clinically very meaningful and important. ORE-001 has the potential to redefine how we manage post-operative recovery, particularly in high-risk surgical populations.”


Herantis advances HER-096 after successful phase 1b Parkinson’s trial

Herantis Pharma has announced positive topline results from its phase 1b trial of HER-096 in people living with Parkinson’s disease, with all primary and secondary endpoints met. The company now plans to advance the drug into a phase 2 trial in 2026 to evaluate efficacy, safety and tolerability in early-stage patients.

The trial showed that repeated 200mg and 300mg doses of HER-096 were generally safe and well tolerated. The pharmacokinetic profile matched predictions from earlier single-dose studies in healthy volunteers, and crucially, blood-brain barrier penetration was confirmed in Parkinson’s patients.

Data from the study indicates that a twice-weekly 300mg dosing regimen is suitable for phase 2. The full data set, including exploratory biomarker data, is expected before the end of 2025.

Anders Gersel Pedersen, Chairman of the Herantis Scientific Advisory Board, said: “The phase 1b results combined with the previously reported clinical and preclinical data provide a good rationale for advancing HER-096 into a phase 2 trial focused on efficacy.”

Antti Vuolanto, CEO of Herantis Pharma, explained: “We are thrilled to achieve this important milestone, successfully meeting the trial’s primary and secondary endpoints. These results are a testament to our team’s expertise and dedication, demonstrating our ability to drive the development programme forward efficiently."

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