Archive: Company News
Company News: Curetis Completes Sample Enrollment in Unyvero U.S. FDA Trial in Lower Respiratory Tract Infections
– Last patient enrolled in prospective arm of IVD trial
– More than 2,250 prospective and retrospective samples enrolled in study
– Data to be complemented with up to 500 additional contrived samples with focus on rare pathogens
Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced the completion of patient enrollment in its Unyvero U.S. FDA trial. The primary endpoint of the prospective and retrospective study is the performance of the Unyvero LRT55 Lower Respiratory Tract cartridge in detecting lower respiratory tract infections as compared to microbiology culture, the current diagnostic standard of care.
In less than a year, a total of 2,254 tracheal aspirate and bronchoalveolar lavage samples have enrolled at nine participating sites across the US, including Mayo Clinic, Northwestern University, Johns Hopkins Hospital, UCLA and Columbia University Medical Center. 1,698 samples were prospectively tested, and 556 were retrospectively tested with the LRT55 Unyvero Lower Respiratory Tract Cartridge as well as using standard of care microbiology culture. The Principal Investigator of the trial is Dr. Robin Patel, Director of the Clinical Bacteriology Laboratory and Infectious Diseases Research Laboratory, and Chair of the Division of Clinical Microbiology at Mayo Clinic.
“Our Clinical Trial Operations team would like to thank all of the participating sites, as well as our Principal Investigator Robin Patel, for their dedicated support during the study,” said Johannes Bacher, Chief Operating Officer of Curetis. “We are proud to conclude patient enrollment this month as planned, after running more than 5,650 Unyvero LRT55 Cartridges in a study with complex sample management logistics.”
“We are very pleased to have finished enrolment of our U.S. study on schedule and according to plan,” said Dr. Oliver Schacht, CEO of Curetis. “In preparing for our IPO during the second half of last year, we outlined a number of anticipated near- and mid-term milestones for the Company. Following the commercial launch of our blood culture (BCU) application cartridge earlier this year, the completion of enrollment in our U.S. trial represents another important accomplishment from that list. I am proud of what our teams have accomplished since becoming a public company, and we look forward to the release of initial top-line data from the study later this year.”
After completion of all molecular comparator testing, data will be unblinded and Unyvero results will be compared against an independent molecular composite comparator based on pathogen DNA analysis by PCR and sequencing. Completion of the analysis is expected in the second half of 2016. Subsequently, a statistical analysis based on more than 350,000 data points combined from microbiology, Unyvero runs, additional molecular testing and bidirectional sequencing will be prepared. FDA submission is anticipated before the end of the year, with a goal of securing FDA clearance for Unyvero and commercialization of the technology in the first half of 2017.
In order to provide additional data points for certain rare pathogens, e.g. Legionella, Mycoplasma, Pneumocystis, up to 500 contrived samples from well characterized pathogen strains from several international strain providers will be spiked into negative matrix and tested with Unyvero at several clinical trial sites. It is expected that this phase will add approximately 1,500 cartridge runs, as double testing will be performed on two systems in parallel for software validation, including daily controls and a number of sample repeats.
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, a novel control concept and provides the most comprehensive molecular marker panel for lower respiratory tract infections available today.
Further details about the Unyvero platform are available at the Unyvero product website – www.unyvero.com.
Company News: Curetis Reports Results of the Annual Shareholder Meeting Held on June 16, 2016
– Dr. Prabhavathi Fernandes elected as member of the Supervisory Board
Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis”), a developer of next-level molecular diagnostic solutions, today reported the results of its Annual Shareholder Meeting (“AGM”) held in Amsterdam on June 16, 2016.
The shareholders approved all items on the agenda of the AGM, including the election of Dr. Prabhavathi Fernandes (CEO of Cempra Pharmaceuticals, Inc., Chapel Hill, NC, USA) as a member of Curetis´ Supervisory Board for a three-year term until 2019. Prabhavathi Fernandes has profound knowledge in infectious diseases and antibiotics as well as experience in successfully founding, building up and leading several biotech companies and taking one public on Nasdaq raising more than half a billion dollars.
Moreover, Dr. Holger Reithinger and Dr. Rudy Dekeyser were re-elected for another one-year term, respectively. In addition, the proposed resignation of Dr. Frank Mühlenbeck, the creation of a new Stock Option Program for the Company and associated changes to the Supervisory Board remuneration policy as well as changes to the Management Board’s Remuneration Policy and Stock Option grants were also approved by the shareholders.
“We are excited about the election of Prabha Fernandes to our board,” said Oliver Schacht, CEO of Curetis. “She brings unparalleled MDx industry expertise and will play a crucial role in helping Curetis prepare for the planned market launch in the US. Moreover, we are pleased that all proposed AGM resolutions have been approved by our shareholders.”
Company News: Curetis Announces Excellent Study Data and Multi-Region Launch of Unyvero BCU Blood Culture Application Cartridge
– Interim data from prospective multicenter evaluation show 98% concordance with conventional microbiology
– Unyvero results on average available 24 hours earlier than in conventional microbiology, enabling rapid decision on appropriate antibiotic therapy
Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced the broad commercial roll-out of its new Unyvero BCU Blood Culture Application Cartridge, which was introduced during ECCMID in April 2016. The roll-out has been initiated in Europe, the Middle East and Asia via Curetis’ internal sales force and the company’s distribution partner network.
The market launch is supported by excellent interim data from an external, prospective, multicenter evaluation comparing the performance of the BCU Application Cartridge against the performance of conventional microbiology work-up of positive blood cultures that is ongoing at three European hospitals.
The interim analysis on approximately 100 patient samples demonstrated a 98% concordance with conventional microbiology. Additional pathogens that escaped detection by conventional microbiology were found in several cases. On average, Unyvero results were available 24 hours earlier and in some cases up to two days earlier than results obtained by routine diagnostic methods. The data also confirm compatibility with most commonly used blood culture systems, namely BacT/ALERT® (BioMérieux) and BD BACTEC™ (Becton Dickinson).
Curetis expects to finalize the prospective evaluation during the third quarter of 2016 and is planning to submit a joint publication with the clinical investigators of the study to a peer-reviewed medical journal.
“The new Unyvero Application for blood cultures has truly proven its worth in our microbiology laboratory, thanks to its broad coverage of pathogens, the identification of antibiotic resistances and its easy handling,” said Dr. Monika Huber, senior physician and private lecturer of the Institute of Pathology and Bacteriology, at SMZ Otto Wagner Spital in Vienna, Austria, one of the clinical investigators of the study. “Even with mixed infections, excellent results are obtained within a few hours – a very valuable time gain for bringing adequate therapy to the patient.”
“We are very pleased with these first data from the prospective evaluation of our BCU Blood Culture Application,” said Dr. Achim Plum, CCO of Curetis, “They demonstrate the versatility and utility of our new BCU Application Cartridge in the rapid and reliable identification of pathogens and antibiotic resistance markers in positively flagged blood cultures. The results also indicate its significant potential to improve the management of critically ill patients with blood stream infections.”
Company News: Anergis to Present New Data on Lead Compound AllerT at the 35th European Academy of Allergy and Clinical Immunology (EAACI) Congress 2016
– Additional clinical Phase IIb data on the safety and efficacy of AllerT published in the Journal of Allergy and Clinical Immunology
– Composition-of-matter patent granted for AllerT by the European Patent Office
Anergis, a company developing proprietary ultra-fast allergy immunotherapeutics, today announced upcoming presentations, the publication of new clinical data and the strengthening of the IP position of its proprietary, clinical-stage COP immunotherapy lead compound AllerT for the treatment of patients with allergy to birch pollen.
Presentations at the EAACI 2016
On June 13 and 14, Anergis will present new clinical data on AllerT at the 35th European Academy of Allergy and Clinical Immunology (EAACI) Congress (Vienna, Austria, June 11-15, 2016).
Two scientific presentations will feature new findings on the mechanism of action and on the safety and tolerability of AllerT, Anergis´ most advanced product based on the company´s proprietary Contiguous Overlapping Peptide (COP) platform.
The following scientific communications will be presented:
Presentation Title: “Bet v 1-derived contiguous overlapping peptides activate human B- and T Cell responses in human”
Presenter: Alexander Kettner
Time and Date: Monday, June 13, 2015, at 12:15pm CET
Session: Thematic Poster Session LB TPS 5: New Treatment Modalities in Immunotherapy
Abstract #: 1539
Presentation Title: “The emerging tolerability and safety profile of COP’s (Contiguous Overlapping Peptides) containing both T and B cell epitopes in patients with birch allergic rhino-conjunctivitis”
Presenter: Kim Simonsen
Time and Date: Tuesday, June 14, 2016, at 10:30am CET
Session: Oral Abstract Session OAS 20: Safety and Efficacy of Allergen-specific Immunotherapy
Abstract #: A-716-0072-01932
Publication of Phase IIb Data in the Journal of Allergy and Clinical Immunology
Moreover, detailed clinical data from the first Phase IIb field-based study with AllerT were recently published online in the leading peer-reviewed Journal of Allergy and Clinical Immunology.[1] The trial examined the safety and efficacy of a two-month allergen-specific immunotherapy with COPs derived from the major birch pollen allergen Bet v1 in patients with allergic rhinoconjunctivitis in conditions of natural pollen exposure. The primary endpoint was the change in the combined rhinoconjunctivitis symptom and medication score (RSMS) vs placebo.
In this randomized, double-blind, placebo-controlled trial, 239 patients from 23 centers in 7 European countries received 5 preseasonal subcutaneous injections of either a placebo or AllerT at 50μg or 100μg doses.
The change in the RSMS was highly statistically significant vs the placebo in the 50μg group (p=0.015), and both active groups showed significant improvements in quality of life and nighttime nasal symptoms scores. AllerT injections were well tolerated, with a higher frequency of systemic adverse events in the 100μg group.
This study clearly demonstrated that only five injections in a 2-month treatment course with ultra-fast COP allergy immunotherapy provided a clinically meaningful reduction of seasonal allergy symptoms during the first season post treatment, without inducing more safety concerns than conventional SCIT injections. Furthermore, the treatment was shown to trigger a particularly strong IgG4 specific response, a crucial parameter of successful immunotherapy.
In 2015, Anergis released preliminary results from the second pollen season showing that the clinical response in the same group of patients was still present during the second season – without repeated treatment.[2]
New European Patent Granted on AllerT
In April 2016, Anergis was granted a composition-of-matter patent (patent no. 2393511) from the European Patent Office (EPO) on its AllerT product candidate for the treatment of patients with birch pollen allergy, thereby further broadening the geographical coverage of COP-based product patents.
“The Phase IIb trial described in the Journal of Allergy and Clinical Immunology is one of two main studies, which were integrated in this year’s EAACI presentation of the initial safety and tolerability profile of AllerT,” said Vincent Charlon, Chief Executive Officer of Anergis. “These consolidated data show that AllerT is not only efficacious for at least two yearly seasons without repeated treatment, but is also well tolerated across a broad range of doses tested. The ATIBAR trial currently in preparation is designed to deliver definitive efficacy and safety data at two doses of AllerT to identify the lowest effective dose prior to conducting the final Phase III confirmatory trial of AllerT.”
[1] Spertini F, DellaCorte G, Kettner A, de Blay F, Jacobsen L, Jutel M, Worm M, Charlon V, Reymond C, Efficacy of two months of allergen specific immunotherapy with Bet v 1-derived contiguous overlapping peptides in patients with allergic rhinoconjunctivitis: results of a Phase IIb study, Journal of Allergy and Clinical Immunology (2016), doi:10.1016/j.jaci.2016.02.044.
[2] Phase IIb follow-up trial of sustained efficacy of AllerT™ allergy vaccine during a second birch pollen season. Della Corte G.1, Jutel M.2, Jacobsen L.3, De Blay F.4, Worm M.5, Spertini F.6, Rak S.7, Kettner A.1, Reymond C.1, Charlon V.1
1Anergis SA, Epalinges, Switzerland, 2Wroclaw Medical University, Wroclaw, Poland, 3Allergy Learning, Copenhagen, Denmark, 4CHRU, Strasbourg, France, 5Charité – Universitätsmedizin Berlin, Berlin, Germany, 6CHUV, Lausanne, Switzerland, 7Sahlgrenska University Hospital, Gothenberg, Sweden