Shares in AC Immune (ACIU) are surging 56% in Thursday’s pre-market trading after the biopharma announced the initiation of the second highest dosing group in the its Phase 1b/2a clinical trial evaluating ACI-35.030 for the treatment of Alzheimer’s disease (AD).The decision to advance to the higher dosing group follows encouraging interim safety, tolerability and immunogenicity results from the initial dosing group.
Immunization with anti-Tau vaccines has become an important strategy for the treatment of AD and other neurodegenerative diseases characterized by Tau pathology, says AC Immune.
ACI-35.030, which is being developed in collaboration with Johnson & Johnson’s (JNJ) Janssen Pharmaceuticals, Inc., is the first AD vaccine candidate designed to generate a specific antibody response against pathologic phospho-Tau (pTau) proteins in the brain. This can potentially reduce the spread and seeding of Tau pathology throughout the brain.
Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: “The fact that ACI-35.030 shows encouraging safety and immunogenicity at the lowest dose in this elderly patient population is highly meaningful and we look forward to quickly enrolling this next dosing group.”
She continued: “Tau-targeted approaches may have a much broader therapeutic window to potentially disrupt, slow or prevent disease progression at both early and advanced disease stages. Pathological pTau occurs early in the disease process, years before accumulation of Tau deposits. Therefore, our pTau-targeting approach holds significant promise for the treatment of AD at different disease stages.”
This Phase 1b/2a trial is a randomized, multicenter, double-blind, placebo-controlled clinical study with a primary objective to assess the safety, tolerability and immunogenicity of different doses of ACI-35.030 over a 48-week treatment phase in 24 patients with early AD. Other endpoints will assess clinical and cognitive parameters as well as additional immunogenicity and safety parameters.
Alzheimer’s disease is a devastating neurodegenerative disease of the central nervous system which is responsible for 60-80% of all cases of dementia and progressively destroys the cognitive abilities of those who develop the disease.
HC Wainwright analyst Andrew Fein has a buy rating on ACIU with an $11 price target (53% upside potential). “We believe a disconnect remains for fully appreciating AC Immune’s AD platform as reflected by its market capitalization, which we believe can be realized as upside following potentially validating data anticipated later this year” he commented on July 9. (See ACIU stock analysis on TipRanks)
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