Herantis Pharma: newly published clinical evidence validates HER-096 Phase 2 study design
Herantis Pharma Plc – Press release 5 November 2026 at 8:55 EET
Herantis Pharma: newly published clinical evidence validates HER-096 Phase 2 study design
- Phase 2 study will assess HER-096’s efficacy in approximately 100 participants, using a smartphone-based motor assessment as the primary efficacy endpoint, including nine months of placebo-controlled treatment followed by six months of HER-096 treatment for all participants
- Newly published clinical evidence shows smartphone-based motor assessments to be 2.5 times more sensitive to disease progression than conventional clinical measures, enabling an estimated 80% reduction in the number of study participants needed to detect the same treatment effect
- Phase 2 preparations are progressing, with Clinical Trial Application (CTA) submission targeted for Q4 2026 and first dosing anticipated in H1 2027
Espoo, Finland, 5 November 2026: Herantis Pharma Plc (“Herantis”), a clinical-stage company developing disease-modifying therapies to stop the progression of Parkinson’s disease, today highlights newly published clinical evidence supporting the design of its upcoming HERMOD (HER-096 Motor Outcomes and Disease Modification in Parkinson’s Disease) Phase 2 study of HER-096, alongside progress in manufacturing and clinical preparations.
Antti Vuolanto, CEO of Herantis Pharma, said: “The newly published clinical evidence related to smartphone-based motor assessments reinforces our confidence in the design of the HERMOD study and its ability to generate meaningful clinical data from approximately 100 participants. Combined with our progress in manufacturing and formulation development, this represents an important step forward for HER-096 and strengthens our position in discussions with potential pharmaceutical partners.”
HER-096 Phase 2 study design
Herantis has extended the double-blind, placebo-controlled treatment period of its Phase 2 proof-of-concept study from six to nine months, followed by six months during which all participants will receive HER-096. The revised design is expected to provide further insight into HER-096’s effects over time and help explore its disease-modifying potential. The changes do not increase the study costs compared to previous estimates or increase Herantis’ overall funding requirement through the Phase 2 readout.
The Phase 2 HERMOD study will enroll approximately 100 people with recently diagnosed Parkinson’s disease who are not yet receiving symptomatic medication. The primary efficacy endpoint is the Digital Motor Score (DMS), an objective smartphone-based measure of motor performance developed by Indivi, Herantis’ digital biomarker partner. Additional endpoints include clinical assessments of motor and non-motor symptoms and cognition, imaging, and biomarker measures.
Recent Indivi analyses showed that smartphone-based motor assessments were approximately 2.5 times more sensitive to disease progression than conventional clinical measures in a recent Phase 2 Parkinson’s disease study (https://doi.org/10.1002/mds.70479). An accompanying preprint estimated that this increased sensitivity could reduce the number of participants needed to detect the same proportional treatment effect by approximately 80%. The preprint is available on medRxiv (DOI: 10.64898/2026.09.29.26363876).
Manufacturing and formulation advances support Phase 2 and future development
HER-096 manufacturing has been successfully scaled up from the hundreds of grams in Phase 1 to several kilograms for Phase 2 with improved product quality and reduced unit manufacturing costs.
Herantis has also developed a formulation that allows the full 300 mg dose to be administered in a single subcutaneous injection.
Phase 2 operational readiness
Study preparations are progressing as planned, with site identification and feasibility assessments ongoing. Clinical Trial Application submission remains targeted for Q4 2026, with first participant dosing expected in H1 2027, subject to financing and regulatory approvals.
For more information, please contact:
Herantis Pharma Plc
Tone Kvåle, CFO
Tel: +47 915 19576
Email: [email protected]
ICR Healthcare
Sarah Elton-Farr, Stephanie Cuthbert, Phillip Marriage
Tel: +44 20 3709 5700
Email: [email protected]
Certified Advisor:
UB Corporate Finance Ltd
Tel: +358 9 25 380 225
Email: [email protected]
About Herantis Pharma Plc
Herantis Pharma Plc is a clinical-stage biotechnology company developing disease-modifying therapies for Parkinson’s disease. The Company’s lead product, HER-096, is a first-in-class small peptide that combines the neuroprotective mechanism of cerebral dopamine neurotrophic factor (CDNF) with the convenience of subcutaneous administration. In a Phase 1b clinical trial, HER-096 was shown to be generally safe and well tolerated in Parkinson’s disease patients. Herantis plans to advance HER-096 into a Phase 2 clinical trial in 2027 to evaluate efficacy, safety and tolerability in people with early-stage Parkinson’s disease.
Herantis is listed on the Nasdaq First North Growth Market Finland.
Company website: www.herantis.com