Herantis recently completed a pre-IND meeting with the FDA to discuss the planned clinical development of HER-096. The FDA raised no concerns regarding the company’s chemistry, manufacturing and controls (CMC) information or preclinical data package and confirmed that, based on the current data package, Herantis would be in a position to activate U.S. clinical sites should an Investigational New Drug (IND) application be submitted. The FDA considered the Phase 2a trial design appropriate for the current stage of development and discussions also included the endpoint strategy for future clinical studies.

“The successful outcome of our FDA meeting is an important milestone as we advance HER-096 towards Phase 2 development. Together with our positive Phase 1b data, encouraging biomarker findings and Horizon Europe grant support, the FDA feedback strengthens our confidence in the program and our development strategy. With the study design now finalized and our CRO partner selected, we have taken a significant step towards initiating the Phase 2a proof-of-concept efficacy study. We look forward to initiating the study and generating data that will further evaluate HER-096’s potential as a disease-modifying treatment for Parkinson’s disease,” says Antti Vuolanto, CEO of Herantis Pharma.

The Phase 2a study

The Phase 2a study is designed to evaluate the efficacy, safety and tolerability of HER-096 in patients with early-stage Parkinson’s disease and is expected to provide the first evidence of its potential to deliver meaningful clinical benefit in patients. The randomized, double-blind, placebo-controlled study is expected to enroll approximately 100 newly diagnosed Parkinson’s disease patients who are not receiving symptomatic medication across multiple sites in Europe. Patients will receive twice-weekly subcutaneous dosing of HER-096 or placebo for six months, followed by a six-month open-label extension. The study will use a Digital Motor Score (DMS) as its primary endpoint, complemented by established clinical assessments, imaging and biomarker analyses. The integration of Indivi’s digital biomarker platform is intended to provide objective and continuous assessments of disease progression and treatment response.

Herantis has appointed CTC Clinical Trial Consultants AB (CTC) as the clinical CRO to support the execution of the Phase 2a study. CTC brings extensive experience in Parkinson’s disease clinical trials and will support study start-up, site management and operational execution across participating study centers.