Biopharmaceutical company Amgen, along with two other drugmakers Takeda and UCB, has enrolled the first patient in a global platform trial of hospitalised patients with Covid-19.
Three drugmakers are part of the COVID R&D Alliance, which was established in March this year to boost the study candidates without regard to company affiliation.
The alliance, which includes over 20 major pharmaceutical and biotech companies, enables members to share clinical trial data and real-world evidence, in addition to crowd-sourcing early-stage candidates to detect mechanisms and treatments that help treat Covid-19.
Dubbed as COMMUNITY trial (Covid-19 multiple agents and modulators unified industry members), the adaptive, randomised, double-blind, placebo-controlled platform study has been designed to evaluate multiple candidates as a potential treatment for hospitalised patients with Covid-19.
An adaptive design is being used by the COMMUNITY to facilitate the addition, removal and simultaneous study of multiple therapeutic candidates during the trial. Multiple candidates will be evaluated against a shared placebo-controlled arm.
The platform study will be conducted at global sites in the US, Brazil, Mexico, Russia, South Africa, and other countries.
Initial therapies to be tested under the platform study have been selected based on their potential to inhibit or control the immune response or the resulting inflammation.
The study will evaluate Amgen’s Otezla (apremilast) that may inhibit immune response inflammation and Takeda’s investigational intravenous administration of lanadelumab that can modulate the kallikrein-kinin system and inhibit the production of bradykinin.
It will also assess UCB’s zilucoplan, an investigational medicine with a potential to reduce overactivation of the immune system that leads to acute respiratory distress syndrome (ARDS).
Otezla already entered the trial, while lanadelumab and zilucoplan are expected to enter in the coming weeks. The platform study intends to test other anti-viral, immunomodulating and vascular agents in the coming months.
Amgen research and development executive vice president Dr David Reese said: “As this insidious virus rapidly spreads around the globe, doctors need options to treat hospitalized patients who are actively sick and experiencing a range of symptoms as the disease progresses.
“Working hand-in-hand with our peers, we hope to find options that could potentially save lives of the patients who will need treatments for Covid-19 before widespread availability of a vaccine.”
In August this year, Novavax agreed to grant the Japanese licensing rights to NVX‑CoV2373, a vaccine candidate modified from the genetic sequence of the Covid-19 causing SARS‑CoV‑2 virus, to Takeda Pharmaceutical.