VIENNA—Themis Bioscience announced yesterday the publication of the Phase 2 results of its lead vaccine candidate (MV-CHIK) in The Lancet. The article is entitled, “Immunogenicity, safety and tolerability of the Measles-vectored Chikungunya vaccine MV-CHIK: A double-blind, randomized, placebo- and Priorix-controlled Phase 2 trial.”
The recently completed trial was designed to assess the safety, tolerability and immunogenicity of MV-CHIK to protect against chikungunya fever, a mosquito-transmitted disease that has no current treatment or prevention options. The trial, which included 263 healthy participants, was conducted at four study sites in Austria and Germany. The primary endpoint, defined as the presence of neutralizing antibodies against chikungunya, four weeks after administration of one or two MV-CHIK injections, was met across all treatment groups.
MV-CHIK is the first candidate from Themis’ innovative immunomodulation platform based on the measles vector, one of the safest and most effective vaccines available. The double-blinded, randomized, placebo- and active comparator- controlled Phase 2 trial was designed to evaluate two dose levels by assessing immunogenicity, safety and tolerability of MV-CHIK. The trial also assessed the impact of pre-vaccination against the vector in two groups that received Priorix, the live attenuated measles, mumps and rubella (MMR) vaccine, prior to MV-CHIK administration.
“These positive results provide an important clinical proof-of-concept for MV-CHIK and position us for the initiation of a Phase 3 trial. They also highlight the capabilities of our measles vector platform to efficiently produce excellent vaccine candidates and bring us one step closer towards providing a vaccine product against chikungunya, an emerging disease with significant outbreak potential and serious debilitating long-term effects,” said Dr. Erich Tauber, CEO and founder of Themis. “The recent addition of chikungunya fever to the Tropical Disease Priority Review Voucher Program of the US Food and Drug Administration is a clear indication that the development of a vaccine is urgently needed and we are highly committed to moving this program forward and seeking approval to commence a pivotal Phase 3 trial in the near term.”
In the study, MV-CHIK induced neutralizing antibodies against chikungunya in all treatment groups after two injections, with seroconversion rates ranging from 86.4% to 100.0%, depending on dose and administration schedule. The data also showed that pre-existing antibodies against the measles vaccine virus did not affect immunogenicity against chikungunya. Adverse events related to the vaccine were highly similar between groups, with no serious effects recorded. Overall these results suggest that MV-CHIK is a promising and potentially effective vaccine candidate for the prevention of chikungunya.
Emil Reisinger from Rostock University Medical Center and a co-principal investigator of the study added, “Chikungunya has been identified in over 60 countries across Asia, Africa, Europe and the Americas. The outbreak prevalence has increased due to higher frequency of travel and the lack of treatment options, and thus remains a major public health concern. We are excited about the very promising results we have observed in this study and the potential of MV-CHIK as an effective vaccine candidate against chikungunya.”
Themis’ chikungunya candidate has already been tested in over 600 study volunteers in the US, EU and Central America, and was recently awarded PRIME designation status from the European Medicines Agency.