Archive: Company News
Company News: InDex Pharmaceuticals Receives FDA Clearance of IND for Cobitolimod (Kappaproct®) Phase IIb Trial
InDex Pharmaceuticals AB today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application to initiate a phase IIb study with its lead drug candidate cobitolimod (Kappaproct®) in patients with moderate to severe ulcerative colitis (UC).
“The clearance of the IND is a major milestone for InDex Pharmaceuticals in our efforts to develop cobitolimod as a new therapy for patients with ulcerative colitis, a disease with a high unmet medical need,” said Peter Zerhouni, CEO of InDex Pharmaceuticals. “We are very pleased about this validation by the FDA, which is based on the extensive preclinical and clinical data package available for cobitolimod, and we look forward to initiating the study later this year. Having clearance from the FDA is key for our on-going discussions with potential licensing partners and investors. We will continue to work with the FDA as the development of this product progresses.”
Cobitolimod (Kappaproct®) is InDex Pharmaceutical’s lead drug candidate in late-stage clinical development for moderate to severe ulcerative colitis, a debilitating, chronic inflammation of the large intestine. Cobitolimod is a first-in-class Toll-like receptor (TLR) 9 agonist that functions as an immunomodulatory agent by mimicking microbial DNA, the natural ligand of the receptor. Cobitolimod provides local anti-inflammatory effects, leading to healing of the colonic mucosa and improvement of clinical symptoms. In January 2016, WHO recommended the INN name cobitolimod. The substance is also known as Kappaproct® and DIMS0150.
The product has achieved clinical proof-of-concept in moderate to severe ulcerative colitis, with a very favorable safety profile. Data from four placebo-controlled clinical trials show that cobitolimod has statistically significant effects on those endpoints that are most relevant in this disease, both from a regulatory and clinical perspective. These endpoints include the key clinical symptoms such as blood in stool, number of stools, and mucosal healing, respectively.
The planned phase IIb study will be a randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of cobitolimod in inducing clinical remission in patients with chronic active moderate to severe ulcerative colitis as compared to placebo. The study will evaluate higher doses and more frequent dosing than those used in previous studies with the goal to provide substantially higher efficacy, while maintaining the compound’s superior safety profile.
Company News: Humabs BioMed and the Institute for Research in Biomedicine announce the successful isolation and characterization of a protective, human-derived antibody against Ebola
– International collaboration publishes results in two Science papers
– Clinical development to start with support by DARPA
Humabs BioMed SA, a Swiss antibody therapeutics company, and the Institute for Research in Biomedicine (IRB) affiliated to the Università della Svizzera italiana today announced the identification, isolation and characterization of two Ebola virus neutralizing monoclonal antibodies from the blood of a survivor of an Ebola infection. The results were achieved through an international collaboration with leading research institutes. As published in this week’s Science, one of the fully human antibodies is completely protective against lethal Ebola infection – even when given as single treatment and as late as five days after infection. A second publication, also in this week’s Science, identifies novel sites of vulnerability on the Ebola virus glycoprotein and reveals the molecular bases of virus neutralization by the human antibodies, providing new clues for vaccine design.
The Ebola virus causes hemorrhagic fever with a mortality rate of up to 90%. There is currently no approved Ebola therapy or vaccination. However, it is known that Ebola infection survivors carry life-long immunity preventing further infections. In a joint effort with researchers from the U.S. National Institute of Health (NIH) and the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Humabs BioMed and IRB were able to isolate two human antibodies against Ebola from the blood of two survivors of a 1995 Ebola outbreak 11 years after infection. Two antibodies code-named mAb100 and mAb114 demonstrated high virus-neutralizing capacity even when mAb114 was given as a monotherapy five days after infection.
Subsequently, researchers from the U.S: National Institute for Allergic and Infectious Diseases (NIAID), the Geisel School of Medicine at Dartmouth (Hanover, USA) and the School of Medicine Tsinghua University (Beijing, China) in collaboration with Humabs and the IRB characterized the targets addressed by the two antibodies. Both interfere with a glycoprotein that is essential for the binding of the virus to its host cells. This protein contains a certain loop that is being removed before the virus can enter cells. While mAb100 prevents the removal of the loop, mAb114, which is effective as a monotherapy, remains attached to the protein even after the loop is cut out. This is an entirely novel site of Ebola virus vulnerability that has never been reported to date and may open up new possibilities for the development of further preventive and therapeutic measures.
The lead mAb114 antibody is now being manufactured and developed for clinical testing with the support of the Defense Advanced Research Projects Agency (DARPA, Arlington, USA).
Company News: Curetis Starts Final Validation Study for New Unyvero Blood Culture Application Cartridge
– Data and CE-IVD launch expected in Q2, 2016
– Company also prepares launch of 2nd generation ITI Application Cartridge and novel product for intra-abdominal infections
Curetis N.V. (the “Company” and, together with Curetis AG, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced the start of a CE performance evaluation study for its third Unyvero Application Cartridge. The BCU Blood Culture Application Cartridge is designed to diagnose infections that are spreading through the bloodstream and is targeting clinically most relevant microorganisms and related antibiotic resistance markers. Curetis expects data from the study and the subsequent launch of the CE-IVD-marked BCU Application Cartridge in Q2, 2016.
The BCU Application Cartridge features a unique and differentiated test panel covering more than 100 diagnostic targets, including tests to identify Gram-positive and Gram-negative bacteria, fungi and mycobacteria, as well as tests for up to 16 antibiotic resistance markers. The Application Cartridge is using positively flagged blood culture samples from bottles inoculated with blood or punctate. Comprehensive results are delivered within 4 to 5 hours and require just a few minutes of hands-on time.
For the study, the BCU Application Cartridge is being validated in conjunction with the most common commercial blood culture systems, using about 250 blood culture samples. Previous studies testing around 200 BCU cartridges as part of the analytical and pre-clinical performance evaluation were already completed successfully. The data, which are to be published and presented at upcoming conferences, are expected to support the CE-IVD-marking of the BCU Application Cartridge. Three clinical sites in the DACH region already have agreed to further evaluate the Unyvero BCU Application Cartridge in routine clinical settings once it becomes available as a CE-IVD-marked product.
Curetis has also progressed with the development of a second-generation ITI Application Cartridge for implant and tissue infections and has started the development program towards a novel Application Cartridge targeting intra-abdominal infections.
Further pipeline updates and an outlook of additional future product opportunities will be provided in H2, 2016, including an update on the preparation of Curetis’ next US FDA trial for a second Unyvero Application Cartridge for the US market once the ongoing LRT55 FDA trial has been completed.
Company News: InDex Pharmaceuticals Receives Approval of the International Nonproprietary Name (INN) Cobitolimod for their Lead Drug Candidate Kappaproct®
InDex Pharmaceuticals AB today announced that the World Health Organization (WHO) has recommended cobitolimod as the International Nonproprietary Name (INN) for Index´s lead drug candidate Kappaproct®, which is a first-in-class Toll-like receptor (TLR) 9 agonist in late-stage clinical development for moderate to severe ulcerative colitis.
The aim of the INN system is to provide a unique and universally designated name for each pharmaceutical substance to facilitate the identification of active pharmaceutical ingredients. A nonproprietary name is also known as a generic name. The name cobitolimod has been selected and passed the review of the Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations. Following public consultation over four months, it has reached the status of recommended INN and will be included in the forthcoming list of recommended INN published by the WHO.
Kappaproct (cobitolimod) is InDex Pharmaceutical’s lead drug candidate in late-stage clinical development for moderate to severe ulcerative colitis, a debilitating, chronic inflammation of the large intestine. Kappaproct provides local anti-inflammatory effects, leading to healing of the colonic mucosa and improvement of clinical symptoms.
Kappaproct is a single-stranded, DNA-based synthetic oligonucleotide that functions as an immunomodulatory agent by targeting TLR9 and thereby mimics microbial DNA being the natural ligand of the receptor. Kappaproct has achieved clinical proof-of-concept in moderate to severe ulcerative colitis, with a very favorable safety profile. Data from four placebo controlled clinical trials show that Kappaproct has statistically significant effects on those endpoints that are most relevant both from a regulatory and clinical perspective, such as key clinical symptoms, i.e. blood in stool, number of stools, and mucosal healing.