Lunar Lunar is a
lipid nanoparticle drug delivery system which targets specific cells inside the body to deliver a payload of RNA into the cell. Once release of the RNA into the cell occurs, the normal
translational machinery of the cell can interact with the RNA to make a functional protein with a therapeutic effect. Prior to the Lunar technique, efficient
in vivo delivery has also been challenging because existing lipid
nanoparticles at the time could cause liver damage and elicit a strong
immune response. This lipid nanoparticle delivery system has been used to deliver
ornithine transcarbamylase messenger RNA to liver cells in order to treat
citrin deficiency and
ornithine transcarbamylase deficiency. OTCD is the most common
urea cycle disorder, which impacts an individual's ability to remove toxic waste products from the body. In collaboration with the
Salk Institute for Biological Studies in La Jolla, California, successful delivery of a Factor IX messenger RNA to the liver was reported, which suggested viability of the approach to potentially treat diseases requiring protein replacement. In 2019, a drug named ARCT-810 which uses Lunar, received FDA
orphan drug status for treating ornithine transcarbamylase deficiency. The orphan drug designation is granted to drugs capable of treating rare diseases that affect less than 200,000 people in the United States, and grants seven years of marketing exclusivity after approval. On April 13, 2020, it was announced that the company's
investigational new drug application for Phase 1b study in patients with OTCD was allowed to proceed by the U.S. FDA. Clinical trials in patients began in June 2020.
Lunar-COV19 ARCT-021 and Starr In response to the
COVID-19 pandemic, Arcturus partnered with
Duke–NUS Medical School to develop a
COVID-19 vaccine using a combination of self-replicating mRNA with a Lunar delivery platform which increases the level and duration of expression of a therapeutic protein). The company also partnered with Catalent and Recipharm, contract development and manufacturing organizations, to manufacture multiple batches of Arcturus'
COVID-19 mRNA vaccine candidate. Lunar-COV19 clinical trials in healthy volunteers began in July 2020. Phase 2 clinical trials were approved in the United States and Singapore by the FDA and HSA, respectively in December 2020.
Next-generations On 2 August 2021, ARCT-154 started a clinical trial in Vietnam for next-generation development. The next day, the firm announced that the application of approval for the clinical trial Phase I/II in Singapore called ARCT-165. Also application of ARCT-154 for phase I/II. The vaccine was authorised in Japan in November 2023, and the European Union in February 2025.
Other projects Lunar-CF is a project in collaboration with the
Cystic Fibrosis Foundation to treat
cystic fibrosis. Lunar-FLU is a wholly owned program to protect against the
influenza virus. Arcturus is combining its self-replicating mRNA Starr technology with Lunar to develop a prophylactic vaccine against influenza. Lunar-GSD is a project in collaboration with
Ultragenyx to treat
glycogen storage disease type III. Lunar-Rare is a project in collaboration with
Ultragenyx to develop therapeutic candidates for rare disease targets. Lunar-HBV is a project in collaboration with
Janssen to develop medicines for the treatment of hepatitis B virus infection. Lunar-NASH is a project in collaboration with
Takeda to develop medicines for
non-alcoholic steatohepatitis (NASH) and other gastrointestinal disorders. Lunar-RPL is a project in collaboration with
Synthetic Genomics to develop improved technology for vaccines and therapeutics. Lunar-AH is a project in collaboration with
Synthetic Genomics to develop infectious disease prophylactic vaccines. ==References==