Pre-clinical studies have shown that intranasal RIG-101, a novel RIG-I agonist, significantly stimulates local innate immunity and exhibits broad-spectrum antiviral activity against human rhinovirus, influenza, and RSV infections. The development of RIG-101 aims to prevent RNA virus transmission in asthma patients and curb seasonal exacerbations. The drug is expected to commence its first human trials by mid-2025.
On September 9, 2024, RIGImmune Inc., a biopharmaceutical research firm focusing on RNA therapeutics, announced three oral presentations at the European Respiratory Society (ERS) Congress 2024 in Vienna, Austria. These presentations highlighted the promising pre-clinical results of their lead product candidate, intranasal RIG-101. The data demonstrated that RIG-101 could significantly reduce viral loads and activate innate immune responses when delivered directly to the respiratory tract.
RIG-101 utilizes the company's patented NEED™ (Nano-Emulsion Enhanced Delivery) platform. This innovative delivery system enables the transport of various RNA payloads without relying on lipid nanoparticle (LNP) encapsulation. The studies indicated that RIG-101 has the potential to prevent RNA virus transmission and mitigate viral infection-related respiratory complications in vulnerable populations, such as immunocompromised individuals and those with chronic respiratory conditions like asthma and COPD.
Dr. Kazuhiro Ito, a senior author of the studies and a principal research fellow at Imperial College London, commented on the significance of these findings. He emphasized that previous intranasal RNA therapeutics faced challenges due to inefficient uptake by nasal epithelial cells. However, RIG-101, formulated with NEED™ technology, proved to be effectively absorbed and optimally activate the innate immune system to combat respiratory viruses. This innovative platform allows the direct delivery of RNA therapeutics to the respiratory tract, avoiding the potential damage associated with local LNP administration.
Dr. Susan Sobolov, President of RIGImmune, expressed enthusiasm about the study results presented at the ERS Congress. She noted that RIG-101, combined with the NEED™ platform, showed robust pan-viral activity. The NEED™ technology enables the targeted delivery of a wide range of RNA therapeutics, aligning with the body's biological pathways and minimizing toxicity risks. Validating RIG-101 in pre-clinical systems that have shown clinical relevance reinforces the commitment to advancing the drug to first-in-human trials by mid-2025.
The three studies presented at the ERS Congress provided comprehensive insights into the effectiveness of RIG-101:
1. Pan-antiviral Effects Against RSV and HRV: Led by Leah Daly from Imperial College London, this study demonstrated that prophylactic intranasal RIG-101 effectively induced interferon signaling in human nasal epithelium when delivered prior to and during viral exposure. In vivo testing showed significant reductions in HRV viral load and inflammation.
2. Antiviral Efficacy Against Influenza: Conducted by Hugo Ombredane, a Ph.D. student at Imperial College London, this research revealed that prophylactic intranasal RIG-101 significantly induced type I/III interferon signaling and displayed potent antiviral effects against influenza. The results were comparable or superior to oseltamivir in both in vivo and in vitro models.
3. Adjuvant Effects with H1N1 HA Vaccine: Led by Dr. Shyreen Hassibi from Imperial College London, this study showed that combining intranasal RIG-101 with the recombinant seasonal influenza hemagglutinin (rHA) vaccine more effectively reduced viral load and inflammation associated with H1N1 HA. It also prevented virus-induced weight loss compared to the vaccine alone.
RIGImmune, co-founded by prominent scientists from Yale University, focuses on developing innovative RNA therapeutics to address serious respiratory diseases with high unmet clinical needs. The company's lead product, RIG-101, targets the RIG-I pathway to enhance innate immune responses against viral respiratory diseases. The second product, RIG-301, uses the NEED™ technology to target cystic fibrosis mutations.
RIG-101 is formulated with the NEED™ platform, which employs a non-LNP formulation to deliver RNA directly to the respiratory mucosa, avoiding potential LNP toxicity. This technology encapsulates nucleic acids in a nano-emulsion complex, promoting effective intracellular uptake. Initial research indicates that NEED™ could be compatible with a diverse range of RNA and DNA therapeutics.
How to obtain the latest research advancements in the field of biopharmaceuticals?
In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!