Herantis Pharma De-Risks Parkinson's Asset with Key Safety Milestone

ESPOO, FINLAND – November 26, 2025 – In the high-stakes race to develop a disease-modifying therapy for Parkinson's disease, Finland’s Herantis Pharma has just cleared a critical hurdle. The clinical-stage company announced the successful completion of a six-month Good Laboratory Practice (GLP) toxicology study for its lead candidate, HER-096. While preclinical data points can often be overlooked, this specific milestone is a significant de-risking event, providing crucial long-term safety validation for a drug intended to treat a chronic, progressive condition.

This achievement, demonstrating a favorable safety profile for extended administration, does not exist in a vacuum. It builds directly upon the positive topline results from the company's Phase 1b trial announced in October, which confirmed the drug’s safety, predictable pharmacokinetics, and—most importantly—efficient penetration of the blood-brain barrier in Parkinson's patients. Together, these data points form a robust foundation that strengthens the case for HER-096 as it advances toward a pivotal Phase 2 efficacy trial planned for 2026. For investors and potential partners, this methodical accumulation of evidence signals a program that is systematically mitigating risk and building a compelling value proposition.

“The successful completion of this long-term toxicology study marks another important step forward for our HER-096 program,” said Henri Huttunen, CSO of Herantis Pharma. “Together with the positive results from our Phase 1b trial, we now have a comprehensive safety and pharmacokinetic dataset that provides a strong foundation for advancing HER-096 into Phase 2 clinical development.”

A New Paradigm Beyond Symptom Management

For over half a century, the standard of care for Parkinson's disease has revolved around symptomatic relief, primarily through dopamine replacement therapies like levodopa. While effective in managing motor symptoms initially, these treatments do nothing to halt the underlying death of dopamine-producing neurons. Their efficacy wanes over time, and long-term use is often plagued by debilitating side effects such as dyskinesia. The industry's most profound unmet need remains a therapy that can slow, stop, or even reverse the neurodegenerative process.

This is the challenging landscape Herantis aims to disrupt with HER-096. The drug is a first-in-class small peptide engineered to mimic the activity of Cerebral Dopamine Neurotrophic Factor (CDNF), a naturally occurring human protein with known neuroprotective and neurorestorative properties. While CDNF itself has shown promise, its large size requires invasive intracranial delivery, a major barrier to widespread clinical use. HER-096 was specifically designed to overcome this, offering a patient-friendly subcutaneous administration route while still reaching the brain at therapeutically relevant concentrations.

HER-096’s strategic advantage lies in its multimodal mechanism of action, which attacks the disease on multiple fronts. It modulates the Unfolded Protein Response (UPR) to alleviate cellular stress, reduces the toxic aggregation of alpha-synuclein (a pathological hallmark of Parkinson's), and tempers neuroinflammation. This multifaceted approach represents a sophisticated strategy to break the vicious cycle of neurodegeneration, positioning HER-096 not merely as another symptomatic treatment but as a potential neurorestorative agent capable of fundamentally altering the disease course.

Building Value and Validating Strategy

The successful toxicology study also marks the final milestone of a €2.5 million EIC Accelerator Grant awarded in 2023. This non-dilutive funding, coupled with previous support from The Michael J. Fox Foundation, provides more than just capital; it offers external validation from prestigious scientific and innovation bodies. This is a crucial asset for a company of Herantis's size, which currently has a market capitalization of approximately €51 million on the Nasdaq First North Growth Market Finland.

Investor sentiment has already responded positively to the company's recent progress, with its stock price showing significant gains over the past year. This latest news is likely to further bolster confidence as the company prepares for its most critical and capital-intensive phase of development. The market for Parkinson's disease-modifying therapies is projected to reach over $7.5 billion by 2030, and the competitive pipeline is active. Competitors are pursuing various strategies, from alpha-synuclein-targeting antibodies like Roche and Prothena's Prasinezumab to GLP-1 receptor agonists and genetically targeted LRRK2 inhibitors from Biogen and Denali. HER-096’s unique combination of a proven neurotrophic mechanism and a viable delivery system gives it a distinct position within this competitive field.

The High-Stakes Road to Phase 2

With long-term safety data in hand, all eyes are now on the planned 2026 initiation of the Phase 2 trial, which will be the first true test of HER-096's efficacy in patients. Designing and executing such a trial is notoriously complex. A key challenge in neurodegeneration is identifying and using biomarkers that can accurately measure disease modification, rather than just symptomatic change. Herantis has proactively addressed this, using its grant funding to advance a biomarker development program, the results of which will be critical in designing the Phase 2 study and interpreting its outcomes.

The company is strategically timing its next data release, with a full report on the Phase 1b trial's exploratory biomarker data expected by mid-January 2026. This release is shrewdly scheduled just ahead of the JP Morgan Healthcare Conference, ensuring maximum visibility among the global investment and pharmaceutical communities. A positive biomarker readout, suggesting target engagement and a biological effect on the disease process, would be a major catalyst, potentially attracting partnership interest and fueling the next stage of growth.

While the journey from Phase 2 to market approval is long and fraught with risk, Herantis Pharma has methodically built a strong, data-driven case for HER-096. By systematically addressing key questions of safety, brain penetration, and mechanism of action, the company has positioned its lead asset as a credible contender in the quest to deliver what Parkinson's patients and the market have long awaited: a therapy that offers not just relief, but restoration and hope.