Archive: Company News
Company News: InDex Pharmaceuticals Appoints Uli Hacksell and Jesper Wiklund to its Board of Directors
InDex Pharmaceuticals today announced that Uli Hacksell and Jesper Wiklund have been appointed as new members of the Board of Directors. Professor Hacksell and Mr Wiklund together bring to InDex over 40 years of senior management experience from the life sciences industry in drug development, commercial operations, and business development.
Uli Hacksell has over 20 years of international management experience from both large pharmaceutical and biotech companies. He was the CEO of ACADIA Pharmaceuticals from September 2000 to March 2015, and led the company from a private start-up to becoming a public multibillion dollar company listed on the NASDAQ. Previously, Prof. Hacksell held senior executive positions at Astra AB and was president of Astra Draco, one of Astra’s largest Research and Development subsidiaries, where he directed an organization of more than 1,100 employees. Earlier in his career he held the position of Professor in Organic Chemistry at Uppsala University. He has a diverse Board experience from several long-term assignments, including SynAct Pharma A/S, SLS Invest AB, Action Pharma A/S and the Swedish Medical Products Agency. He currently serves on the Board of Directors of Uppsala University.
Jesper Wiklund has over 20 years of international commercial experience in the biotechnology and pharmaceutical industry. Mr Wiklund currently holds the position of Managing Director at Oberland Capital. Mr Wiklund was CEO of InDex Pharmaceuticals from September 2011 to March 2015. Over the course of his career he has completed strategic transactions with an aggregate value exceeding USD 700 million. He previously worked at Swedish Orphan Biovitrum where he was responsible for Business Development, at Wyeth Pharmaceuticals and Elan Pharmaceuticals in the United States and at Evotec in Germany. Mr Wiklund has a B.Sc. from St Marys College of California and a MBA from Harvard Business School.
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.
Company News: InDex Pharmaceuticals regains European rights to Kappaproct® in ulcerative colitis
InDex Pharmaceuticals today announced the termination of a license agreement with Almirall S.A. relating to the drug candidate Kappaproct® for the treatment of ulcerative colitis. Under the agreement, which was signed in March 2014, Almirall licensed exclusive rights to Kappaproct® for the European market. Upon termination of the agreement, InDex regains all worldwide development and commercialization rights for Kappaproct®, which is in late-stage clinical development.
The termination of the agreement follows Almirall’s recent repositioning of their R&D organization to leverage strong formulation capabilities and high-quality New Chemical Entities (NCEs) in Dermatology. Almirall has communicated that their new strategy is to become a leading specialty pharmaceutical company with a strong focus on improving the lives of Dermatology patients and that the company will use its strong cash position to fund growth opportunities in this direction.
Kappaproct® is InDex Pharmaceutical’s lead drug candidate and is in late-stage clinical development for moderate to severe ulcerative colitis, a debilitating, chronic inflammation of the large intestine. Kappaproct® is a DNA-based immunomodulatory sequence (DIMS) that targets the toll-like receptor 9 (TLR9). The recent COLLECT study was conducted in seven European countries and included 131 patients with moderate to severe ulcerative colitis with inadequate response to conventional therapy. They received either Kappaproct® or placebo in addition to conventional treatment. Kappaproct® demonstrated statistically significant effects on endpoints that are highly relevant both from a regulatory and clinical perspective such as key clinical symptoms, i.e. blood in stool and number of stools, and mucosal healing. The primary endpoint of clinical remission at 12 weeks using the CAI score was not met due to an unexpectedly high placebo rate for this endpoint. The next clinical study with Kappaproct® is currently being planned in discussion with EU and US regulatory agencies.
Company News: Curetis’ Unyvero System Selected for Global Phase III Antibiotics Trial
– 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.