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AC IMMUNE SA filed this Form 20-F on 03/21/2019
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A Phase 1 clinical trial that involved 75 subjects and evaluated the safety, tolerability, pharmacokinetics and preliminary activity of RG6100 in people with mild-to-moderate AD and in healthy volunteers was completed in the second quarter of 2017. RG6100 was administered at single doses of up to 16,800 mg in healthy volunteers and multiple doses of 8,400 mg in healthy volunteers and patients with AD. The results of the Phase 1 clinical trial were presented at multiple conferences, including the AD/PD in Vienna (March 29-April 2, 2017), the AAIC in London (July 15-20, 2017) and the CTAD in Boston (November 1-4, 2017). No dose-limiting toxicities and no serious adverse events were observed. No participant withdrawals, modifications or interruptions due to an adverse event were reported.


RG6100 exhibited a dose proportional pharmacokinetic profile, indicated CNS exposure and showed a median half-life of 32.3 days. Plasma total Tau concentration increased with increasing drug doses and was 2 times greater in participants with AD than in healthy volunteers, suggesting a pharmacodynamic signal as shown in the figure below.


Figure 21: Anti-Tau antibody RG6100 (Phase 1 results)



Ref: Kerchner et. al, CTAD 2017


Following the completion of the Phase 1 clinical trial, a Phase 2 clinical trial commenced in the fourth quarter of 2017 and the dosing of the first patient triggered a milestone payment of CHF 14 million from Genentech to AC Immune. The trial is being conducted by Genentech and will enroll 360 patients to assess the safety, tolerability and efficacy of the anti-Tau monoclonal antibody RG6100 in people with prodromal-to-mild AD. Participants will receive one of three active doses or placebo for 72 weeks, followed by a 96-week optional open label extension. Primary endpoints include safety assessment and the composite functional and cognitive endpoint CDR (Clinical Dementia Rating scale) sum-of-boxes score. Change from baseline in Tau pathological burden is an exploratory endpoint. The design of the Phase 2 study is shown in the graph below.


Figure 22



Ref: Kerchner et. al, CTAD 2017



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