- Leyden Labs acquired RIGImmune earlier this year, including RIG-101, building on the Company's unique mucosal protection strategy and complementing its clinical pipeline of broadly-protective intranasal antibodies
- RIG-101 is an intranasal therapy designed to strengthen natural antiviral defenses, initially being studied to prevent virus-triggered asthma exacerbations
- In the recently completed Phase 1 trial, RIG-101 was shown to be safe and well tolerated in healthy volunteers and patients with asthma
- Biomarker analyses showed activation of the intended antiviral response in the upper respiratory tract, including induction of interferons and interferon-stimulating genes
Leyden Laboratories B.V. (the "Company" or "Leyden Labs") today announced positive results from a Phase 1 study of RIG-101, an investigational intranasal innate immune modulator being developed to prevent the consequences of common respiratory viral infections in vulnerable patients. Results from the study include a biomarker profile consistent with the expected mechanism of action of the medicine, as well as safety and tolerability in healthy volunteers and patients with asthma, supporting advancement into Phase 2 clinical development. The next planned study is a human rhinovirus challenge study in patients with asthma. RIG-101 is a highly promising product candidate offering a novel approach to mucosal protection and complementing the Company's intranasal antibody strategies.
Key findings:
- Intranasal RIG-101 was safe and well-tolerated in healthy volunteers and patients with asthma at all dose levels with up to 7 days of daily administration
- Daily intranasal dosing of RIG-101 in asthma patients produced the expected interferon response for the target antiviral mechanism of action, including inducing expression of type I and type III interferons and interferon-stimulating genes
RIG-101 is designed to enhance innate antiviral immune responses in patient populations with impaired natural defenses against respiratory viruses. RIG-101 acts on RIG-I, a central mediator of innate immunity, to upregulate interferons and reduce viral infection. RIG-101 exhibits pan-viral activity and is undergoing initial study in asthma, where respiratory viral infections trigger more than 80% of severe exacerbations.
"At Leyden Labs, our mission is to protect people from the consequences of respiratory viral infections by intervening directly in the airway," said Koenraad Wiedhaup, co-founder and Chief Executive Officer of Leyden Labs. "The positive Phase 1 results for RIG-101 demonstrate the potential of innate immune modulation as a powerful complement to our broadly protective antibody programs. Together, these approaches broaden our ability to protect vulnerable patients from the consequences of respiratory viral infections."
Earlier this year, Leyden Labs acquired RIGImmune, Inc. ("RIGImmune"), adding RIG-101 and the proprietary NEED (Nano-Emulsion Effective Delivery) intranasal delivery platform to its growing portfolio of airway-targeted medicines. RIG-101 adds a complementary intranasal approach to the Company's portfolio of broadly protective antibodies that are also aimed at targeting viral infections at the gate of entry. The Company will now support multiple parallel efforts to protect the most vulnerable populations against the consequences of airborne viral infections.
"These Phase 1 results provide encouraging evidence that RIG-101 has the profile needed to advance into Phase 2 patient studies," said Susan Sobolov, CTO of Leyden Labs and former President and COO of RIGImmune. "We believe the enhancement of innate antiviral response represents a promising new therapeutic strategy for the prevention of a broad range of respiratory viral infections in vulnerable patients with chronic airway disease."
About Leyden Laboratories B.V.
Leyden Labs is working to free people from the threat of respiratory viruses. Leyden Labs is leveraging its Mucosal Protection Platform to develop a portfolio of candidates aimed at providing protection against influenza, coronavirus, rhinovirus, and other respiratory viruses through a new class of broadly protective nasal sprays. Systemically administered antibodies or vaccines primarily generate systemic protection, but airborne viruses enter the body through the nose and mouth. Thus, what we need is protection right at the gate, at the respiratory mucosa, to more effectively prevent initial infection and subsequent illness. Leyden Labs is pursuing this strategy by developing nasal sprays that administer broadly protective molecules directly to the respiratory mucosa. These products aim to protect against full viral families, so they keep working even when a virus mutates and evolves. In addition, this intranasal strategy is beneficial for people with weakened immune systems because it does not require a fully functional immune response. To learn more about our approaches to deliver novel mucosal protection, visit www.leydenlabs.com.
About RIG-101
RIG-101 is an investigational first-in-class intranasal innate immune modulator designed to restore antiviral immune responses in patients at increased risk of severe respiratory viral disease. It is part of a novel class of oligonucleotides called stem-loop RNA therapeutics or SLRs. The RIG-101 program is initially focused on preventing virus-induced asthma exacerbations. RIG-101 is delivered using the proprietary NEED (Nano-Emulsion Effective Delivery) platform, a non-lipid nanoparticle intranasal delivery technology designed to efficiently deliver therapeutic payloads directly to the respiratory mucosa. RIGImmune Inc., a subsidiary of Leyden Labs, holds an exclusive license from Yale University to develop and commercialize RIG-101.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260908705473/en/
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