Moderna has dosed the first subject in Phase I clinical trial of its therapeutic candidate, mRNA-6231, for the treatment of patients with autoimmune diseases.
mRNA-6231 comprises a lipid nanoparticle (LNP)‑encapsulated messenger RNA (mRNA) encoding for mutein human interleukin-2 (IL-2) and adapted for improved regulatory T cell selectivity.
IL-2 via selective Tregs expansion is assumed to have a crucial role in immune homeostasis restoration.
The first‑in‑human Phase I dose‑escalation trial will analyse the safety, tolerability, pharmacokinetics and pharmacodynamics of mRNA‑6231 in healthy adults aged between 18 and 50 years.
In the trial, subjects will receive a single subcutaneous dose of the therapeutic candidate.
Moderna noted that mRNA-6231 is its first autoimmune candidate to enter clinical trials. Furthermore, it is the company’s first therapeutic programme to be administered subcutaneously.
Moderna senior vice-president and rare disease, autoimmune and cardiovascular therapeutic area head Ruchira Glaser said: “The initiation of the Phase I study of mRNA-6231 is an important milestone for Moderna, as we now look to bring the potential of mRNA therapeutics to people living with autoimmune diseases.
“Today marks another important step in our mission to deliver on the promise of mRNA to help patients across diseases.”
The company’s mRNA platform is based on basic and applied mRNA science, delivery technology and production. Moderna leveraged the platform to develop multiple therapies and vaccines, including a Covid-19 vaccine.
Moderna currently has active clinical programmes in infectious disease, oncology, cardiovascular, rare disease and autoimmune disease areas.
Last month, Moderna dosed the first subjects in the Phase I/II clinical trial of its quadrivalent seasonal influenza mRNA vaccine candidate, mRNA-1010, in the US.
mRNA-1010 is Moderna’s first seasonal influenza vaccine candidate to enter the clinical development stage.
The vaccine targets lineages listed by the World Health Organization for influenza prevention, which includes seasonal influenza A H1N1, H3N2 and influenza B Yamagata and Victoria.