AC Immune (NASDAQ: ACIU) has announced positive interim safety and efficacy results from the Phase 2 VacSYn trial of its wholly-owned anti-alpha-synuclein (a-syn) active immunotherapy, ACI-7104.056, in early Parkinson’s disease (PD).
According to AC Immune, the results show, for the first time, that targeting a-syn pathology with an active immunotherapy could potentially slow the rate of progression of PD. Disease-related biomarker results, including a-syn CSF levels and neurofilament light (NfL), suggest stabilization of PD pathology.
In a statement, Dr. Andrea Pfeifer, CEO of AC Immune, commented, “The interim Phase 2 data show the potential of our ACI-7104.056 active immunotherapy to slow the progression of Parkinson’s disease and hold the promise of a tremendous step forward for millions of patients. The consistent signs of efficacy, combined with the continuing strong safety record, underline ACI-7104.056’s potential to transform PD treatment and are a strong basis for accelerating development. We will discuss ACI-7104.056 with the regulators to establish a clinical development plan towards registration.”
Werner Poewe, MD, emeritus professor of neurology at Innsbruck Medical University and a leading expert in Parkinson’s disease, added, “The remarkable consistency of the trends observed across multiple disease-related biomarkers and on clinical assessments in the treatment arm are very promising. Importantly, clinical and biomarker outcomes provide signals that the immunological response elicited by ACI-7104 may be associated with beneficial effects on PD progression. Overall, these findings are highly encouraging and fully support further development of the program. If further substantiated the current data would have major implications for future PD therapy. For the first time, we are seeing signals that targeting the underlying pathology of Parkinson’s with active immunotherapy could slow disease progression.”
