Herantis to advance Alzheimer’s treatment after FDA meeting 

Herantis is set to advance the clinical development of its Alzheimer’s therapy following a positive meeting with the US Food and Drug Administration (FDA). 

The company reports it completed a pre-IND meeting with the FDA to discuss the planned clinical development of HER-096, a first-in-class small peptide being developed to treat Alzheimer’s disease. 

Herantis claims the regulatory body confirmed it would be in a position to activate US clinical sites should an Investigational New Drug (IND) application be submitted. The FDA also considered the Phase IIa trial design appropriate for the current stage of development. 

The Phase IIa 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 Phase IIa trial is expected to enrol 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 successful outcome of our FDA meeting is an important milestone as we advance HER-096 towards Phase II development,” said Antti Vuolanto, CEO of Herantis Pharma. 

“Together with our positive Phase Ib 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 finalised and our CRO partner selected, we have taken a significant step towards initiating the Phase IIa 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.” 

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