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.
– Unyvero to be used for pathogen identification and patient inclusion at several clinical sites across Europe
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced that Curetis’ Unyvero System will be used in a Phase III trial of a novel formulation of the antibiotic Amikacin. Unyvero was chosen as a platform to detect pathogens and antibiotic resistances in patients to be enrolled at intensive care units at several clinical trial sites across multiple European countries. Unyvero will be used to support patient identification and help boost enrollment rates at these sites.
Amikacin is an aminoglycoside antibiotic marketed for the treatment of severe, hospital-acquired infections with multidrug-resistant Gram-negative bacteria. The trial is evaluating the efficacy of a novel drug-device combination as an adjunctive therapy for Gram-negative pneumonia in the treatment of intubated and mechanically ventilated adult patients with Gram-negative pneumonia receiving standard of care intravenous antibiotics. The trial is recruiting approximately 650 patients at trial sites worldwide.
Under the terms of the agreement with the sponsor of the trial, Curetis will deliver Unyvero systems and CE-IVD marked P55 cartridges to the trial sites as well as install the systems and provide training and technical support at these sites. The sponsor will fully reimburse Curetis for systems, training, services and consumables. Further financial details were not disclosed.
Company News: Curetis Strengthens Executive Team; Appoints Dr. Achim Plum as Chief Commercial Officer
– Former Siemens Healthcare manager adds broad expertise in molecular diagnostics, sales, marketing, and business development
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced Dr. Achim Plum has been appointed to the newly-created role of Chief Commercial Officer. Dr. Plum joins Curetis from a senior management position at Siemens, where he focused on the assessment and development of novel approaches to the in vitro diagnostic (IVD) market. He will oversee all commercial activities, including international sales, business development, marketing and medical affairs.
Dr. Plum will focus on the continued expansion of Curetis’ commercial organization and infrastructure with the goal of achieving aggressive revenue growth targets in Europe, Asia and the rest of the world. He will also establish a U.S.-based commercial team to support the launch of the Unyvero Solution following FDA approval.
Prior to his position at Siemens, Dr. Plum spent eight years in various commercial roles at Epigenomics, a publicly-traded molecular diagnostics company, most recently as Senior Vice President Business and Strategy. At Epigenomics, he built sales and marketing teams and distribution networks in Europe and the U.S., negotiated strategic commercial agreements with leading diagnostics industry players and led the public company’s corporate communications and compliance functions. He brings significant capital markets experience through his involvement in multiple financing transactions with U.S. and international investors.
– Augmented direct sales force, led by new Head of International Sales to broaden reach in key European markets
– New distribution partnerships in Italy and Middle East
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced the strategic expansion of its sales and marketing program in Europe and the Middle East. The company appointed Klaudija Kiesinger as Head of International Sales for Western Europe and will add four new members to its broader international sales and marketing team by mid-year, bringing the total commercial team size to 14. With this sales force expansion, Curetis has added the U.K., France and the Benelux region (Belgium, the Netherlands and Luxembourg) to its direct-sales markets.
In addition, the Company announced its increased reach into Italy and the Middle East with exclusive, multi-year distribution partnerships. Curetis will distribute the Unyvero Solution through Arrow Diagnostics in Italy and Al Zahrawi Medical in the Middle East (Qatar and the United Arab Emirates).
Since 2012, Curetis has grown to an installed base of more than 60 Unyvero analyzers. The Company currently has 80 systems in the supply chain for 2015, affording customers the potential to run assays covering more than 100 analytes in two highly-multiplexed application cartridges (P55 for pneumonia and i60 for implant and tissue infections). In 2015, the Unyvero product pipeline will be expanded and enhanced by the BC70 Blood Culture Application cartridge. In the coming years, Curetis plans to add further cartridge applications in the fields of sepsis, gastrointestinal tract infections, tuberculosis, CNS infections and pediatrics, among others.
At present, there are several investigator-initiated clinical studies in pediatric applications underway. Various potential pharma projects using Unyvero in clinical trial designs for the development of novel antibiotics afford Curetis additional opportunities for commercial expansion.
In addition to these platform and product enhancements, the Company is expanding its geographic scope, with an FDA trial underway in the U.S. and pre-commercial activities in Asia and other non-European countries.