“These data de-risk the program for potential partners and investors, support readiness for a planned Phase 2 trial to evaluate clinical efficacy and provide guidance for dose selection. Together, they reinforce confidence in the long-term value of the program, and we look forward to discussing these exciting results with prospective pharma partners”, says Antti Vuolanto, CEO of Herantis Pharma.

The Phase 1b trial

The Phase 1b trial consisted of 24 patients with Parkinson’s disease, who received twice-weekly dosing of either HER-096 or placebo over a four-week period. The trial’s exploratory biomarker program assessed biological responses to HER-096 in humans, generating and analyzing more than 2.5 million datapoints.

Untargeted biomarker analyses identified consistent, treatment-associated shifts in biomarkers linked to proteostasis, mitochondrial function and neuroinflammation – biologically relevant pathways to the Unfolded Protein Response and Parkinson’s disease – in response to HER-096 treatment. Alignment between targeted and untargeted biomarker datasets demonstrates modulation of biological pathways directly relevant to HER-096 mechanism of action, in line with the preclinical findings.

“The coordinated shifts we observed across multiple disease-relevant pathways, including proteostasis, mitochondrial function and neuroinflammation, are consistent with a disease-modifying mechanism and align with our preclinical findings. Consistent findings across different analyses and biological layers strengthen our confidence in the therapeutic rationale for HER-096 as development progresses to later-stage clinical trials”, says Henri Huttunen, CSO of Herantis Pharma.