The Espoo-based company, which develops disease-modifying therapies for Parkinson’s disease, will enroll approximately 100 people in the HERMOD study. Participants will have been recently diagnosed and will not yet be receiving symptomatic medication. They will receive nine months of double-blind, placebo-controlled treatment, up from six months. After that, all participants will receive HER-096 for six months. According to Herantis, the revised design does not increase study costs or the company’s overall funding requirement through the Phase II readout.

The primary endpoint is the Digital Motor Score, a smartphone-based measure of motor performance developed by Indivi, Herantis’ digital biomarker partner. Recent Indivi analyses from a Phase II Parkinson’s study showed that such assessments were approximately 2.5 times more sensitive to disease progression than conventional measures. An accompanying preprint estimates that this could cut the number of participants needed to detect the same treatment effect by about 80%.

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.

“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,” says Antti Vuolanto, CEO of Herantis Pharma. “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.”

Herantis has also scaled up HER-096 manufacturing from hundreds of grams to several kilograms. It has developed a formulation that allows the full 300 mg dose to be given in a single subcutaneous injection. The company aims to submit its Clinical Trial Application in Q4 2026, with first dosing expected in the first half of 2027, subject to financing and regulatory approvals.