Company News: Curetis Initiates Next Phase of Unyvero U.S. FDA Trial in Lower Respiratory Tract Infections
– First patient enrolled in prospective arm of IVD trial
– Study to include a total of at least 2,500 patient samples
– Milestone triggers payment of EUR 6.8 million financing tranche
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced the enrollment of the first patient in the prospective phase of its Unyvero U.S. FDA trial.
The primary endpoint of the multicenter U.S. study will be the performance of Curetis’ second generation Unyvero Lower Respiratory Tract (LRT) cartridge, LRT55, in detecting lower respiratory tract infections as compared to microbiology culture – which is currently considered the diagnostic standard of care. In addition, Unyvero results will be compared to an independent molecular composite comparator based on pathogen DNA analysis by PCR and sequencing. At least eight trial sites across the U.S. will participate in the at least 2,500-patient study.
The new trial phase is based on an augmented study design and an enhanced product. This phase of the U.S. trial incorporates two new elements: the latest FDA guidelines for diagnostic trials, and modifications resulting from outcomes of the first phase of this trial. Enrollment completion is anticipated in mid-2016 with FDA submission targeted for the second half of 2016. The Company aims for FDA clearance for Unyvero and subsequent commercialization in early 2017.
The continuation of the trial triggers a EUR 6.8 million financing tranche supported by current Curetis investors.
LRT55 is a second-generation cartridge based on the design of the CE-IVD marked P55 cartridge marketed outside the U.S. It features 40 markers and a novel control concept with live bacteria in the control material and improved representation of pathogens in the panels. As a result, it provides the most comprehensive molecular marker panel for LRT infections marketed today. P55 has demonstrated superior performance in the CE performance evaluation study and additional investigator-initiated clinical studies.
In the U.S. FDA trial, tracheal aspirates and bronchial lavages will be pre-processed by the Unyvero Lysator and transferred to the Unyvero LRT55 cartridge, which is subsequently analyzed by the Unyvero Analyzer. Results are available within four-to-five hours.
The prospective arm of this trial includes at least 1,500 hospitalized patients with suspected lower respiratory tract infections to determine the clinical specificity of the Unyvero LRT55 cartridge.
In another arm of the study, at least 1,000 retrospective blinded patient samples will be analyzed for clinical sensitivity endpoints. All pathogens and resistance markers featured on the Unyvero LRT55 Cartridge will be included in the study. Already, Curetis has collected more than 500 retrospective patient samples across its clinical trial network. All retrospective samples have been tested positive for pathogens on the LRT55 panel by standard microbiology culture.
Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced the start of a prospective clinical trial of its Unyvero™ System and the Unyvero™ P50 Pneumonia Cartridge in the European Union.
The prospective, international, multicenter trial will enroll up to 1,000 hospitalized patients suspected with a lower respiratory tract infection. Patient samples such as sputa, aspirates or bronchial lavages will be pre-processed by the Unyvero™ Lysator and transferred to the Unyvero™ P50 Pneumonia cartridge, which is analyzed by the Unyvero™ Analyzer.
Primary endpoint of the study will be assay performance defined as clinical sensitivity and specificity compared to today’s diagnostics standard of care, microbiology culture. Trial sites include the University Hospital Tuebingen, Germany, the Heart and Diabetes Center Bad Oeynhausen, Germany, the Hospital Clinic of Barcelona in Spain, the Erasme Hospital in Brussels/Belgium, and the University Hospital Jena, Germany. Principal investigator is Prof. Dr. Ingo B. Autenrieth of the University Hospital Tuebingen. Interim topline data are expected for spring 2012.
Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced the opening of its state-of-the-art production facility for disposable Unyvero™ cartridges in Bodelshausen (near Tuebingen, Germany).
The fully automated manufacturing line in a clean room environment is designed to be fully cGMP compliant and offers scalability and flexibility to meet the growing demands of clinical trials and commercialization with the scheduled 2012 EU launch of the Unyvero P50™ pneumonia cartridge.
Initial production capacity is 100,000 p.a. which may be easily expanded to an annual production capacity of 1 mio. cartridges. First product is the Unyvero™ P50 pneumonia cartridge for the identification of 17 pneumonia pathogens and 22 of their clinically most relevant antibiotic resistance markers.
Read more on the Curetis website.
Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced an extension of its Series A financing, bringing the total size of the round to € 24.5 million. CD-Venture joined the funding as a new investor, while all of Curetis’ existing VC investors participated in the round. Several private investors also continued to co-invest.
Following the appointment of Oliver Schacht, PhD, as the new CEO of Curetis last month, this financing transaction is the first step towards funding next year’s commercial launch and roll-out of the Unyvero product platform together with the first CE marked IVD test cartridge for pneumonia and antibiotic resistances in Europe. The additional funds will allow Curetis to pursue a more aggressive strategy towards initiating a US clinical trial in H2-2011 with a goal of filing for FDA approval in 2012. This Series A financing positions Curetis as a solidly funded molecular diagnostics company with near-term commercial-stage products and its unique platform solution addressing a clear unmet medical need in the rapid diagnosis of infectious diseases and antibiotic resistance.
Curetis’ CEO Oliver Schacht will present an update on the company at the upcoming BioEquity 2011 in Paris. The presentation is scheduled for May 23, 2011, at 5:00 pm CET, Room Pont de Sully.
Further details can be found here.