Arrivo Bio has dosed the first subject in a Phase IIb SP-624-202 clinical trial of SP-624, a SIRT6 activator to treat major depressive disorder (MDD).
The multicentre, registration-quality, double-blind, randomised, placebo-controlled trial is set to enrol over 450 adult subjects suffering from MDD.
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The trial aims to assess the effectiveness of SP-624 compared to a placebo for the treatment of MDD.
Participants in the trial will receive two 10mg capsules of SP-624 once a day, amounting to a total daily dose of 20mg, or a placebo.
The primary endpoint for the study is to analyse the change from baseline on the Montgomery-Åsberg Depression Rating Scale (MADRS).
The ten-item depression rating scale is designed to measure the severity of depression symptoms in clinical trials.
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By GlobalDataThe large participant group will allow the trial to investigate various other investigator and subject-rated endpoints, as well as exploratory biomarkers.
Arrivo Bio chief medical advisor Dr Joel Raskin said: “The initiation of this study is an exciting milestone for Arrivo and the SP-624 programme. Despite existing treatments, people with major depression often do not achieve remission and suffer unwanted side effects.
“This large study will significantly augment our current data on SP-624, which has the potential to be a truly transformative treatment for patients suffering from depression.”
In November last year, Arrivo Bio secured $45.25m in a Series B financing round led by Orlando Health Ventures.
The Series B round increased the total funding secured by the company since its inception to a total of $100m.
Solas BioVentures Emerging Healthcare Fund, Rex Health Ventures, and various other investors also participated in this Series B financing.
The company announced plans to use the capital infusion to advance SP-624 through the completion of the Phase IIb/III clinical trials for MDD.
In addition, the capital was intended to support the completion of a Phase II Proof-of-Concept study of RABI-767, which is being developed to prevent patients with pancreatitis from progressing to severe acute pancreatitis.
