24 Nov Kata® Clinical supports sterna biologicals Phase IIa study
VisionHealth’s Kata® Clinical app to support sterna biologicals’ clinical Phase Ila asthma trial
- Kata® Clinical app supports Phase Ila proof-of-concept study investigating sterna biologicals’ lead compound SB010 in moderate to severe asthma patients
- Kata® Clinical will be used to enhance inhaler device handling and therapy adherence, reduce drop-out rates and generate maximally reliable data due to reduced inter patient variability
- The implementation will also support efficient and robust data management and provide validation of the Kata® Clinical app in a clinical trial setting
Munich (Germany), November 23, 2021 – VisionHealth GmbH, a pioneer in digital therapeutics (DTx] for the inhaled treatment of chronic lung diseases, today announced that Kata® Clinical is implemented into sterna biologicals GmbH & Co. KG’s (sterna) Phase Ila proof-of-concept (POC) study in patients with moderate to severe asthma. sterna, an innovative clinical-stage immunology company developing novel biological treatments for chronic inflammatory diseases, has now enrolled the first patient in this study, which aims to investigate the safety and efficacy of its lead compound SB010, an inhaled liquid formulation of a special type of catalytic antisense oligonucleotide to treat asthma. The study is conducted by Dr. med. Kottmann GmbH & Co. KG, a Clinical Research Organization (CRO) that will apply Kata® Clinical also beyond this trial.
Kata® Clinical is a modified Kata® app for Clinical Trials from VisionHealth’s artificial intelligence proprietary platform for inhalation therapy support. The App is offered to pharma, biotech and CRO partners to support clinical trials in the respiratory field. For sterna’s asthma trial, VisionHealth adapted Kata® Clinical to specifically support the run-in period for patient preparation and therapy adherence, ensuring the correctly performed inhalation with SB010. Furthermore, the app facilitates the daily monitoring as well as management of disease and safety parameters, such as asthma symptoms, peak flow values, and emergency medication.
Dr. Sabine Häußermann, CEO and founder of VisionHealth GmbH, said: “The integration of Kata® Clinical into sterna’s trial is an important milestone and essential validation of our technology and business approach. We are convinced that the study will significantly benefit from the use of Kata® Clinical: due to correct inhalator usage patients will deposit the intended dose in the lungs. This will help to obtain valid results. Furthermore, overall data management is facilitated.”
Dr. Marion Wencker, Chief Scientific Officer of sterna biologicals, commented: “We are excited to work with VisionHealth and use Kata® Clinical in our proof-of-concept trial for SB010 in asthma. Kata® Clinical truly is like a versatile ‘pocketknife’ for clinical studies in respiratory indications. During the customization process, we selected those features for the app that would support us best in conducting comprehensive data collection and analysis through integrated questionnaires and journals. Furthermore, we are confident that we can increase data validity by reducing inhalation errors to a minimum: Kata® Clinical will support our study participants with a fascinating combination of artificial intelligence and computer animation.”
Kata® Clinical integrates patient support and features for an easy collection of high-quality data. It is compatible with the most common study data management systems and automatically uploads the data into the electronic case report form (eCRF) and automatically uploads the data into the eCRF. Furthermore, the app provides a direct link between the study centers and each patient, allowing the centers to remotely supervise and monitor the patient in real-time and ensure that no appointments in the study center are missed.
Chronic respiratory diseases like Asthma and Chronic Obstructive Pulmonary Disease (COPD) are usually treated with inhaled drugs. The execution of the inhalation process is prone to errors: studies have shown error rates between 32 and 100%.1,2,3,4,5 Not only therapy but also clinical study outcomes are highly dependent on properly applied drugs including inhaler usage and dosing. Incorrect inhalation results in underdosing of drugs, leading to data scattering and possibly invalid data. Kata® Clinical trains the patient and controls the therapeutic inhalation, thus delivering trustworthy and consistent results.
VisionHealth GmbH is a pioneer of digital therapy support for respiratory diseases. In cooperation with research institutions and selected industry partners, medical experts and IT experts, VisionHealth develops innovative and unique digital health solutions enabling sustainable improvements to existing standard therapies for patients with chronic lung diseases like asthma and COPD. The Munich-based private company, was founded in 2017 by inhalation therapy specialists. Investors include business angels and private investors with many years of industry expertise, particularly in inhalation therapies. www.visionhealth.gmbh
Kata® is a VisionHealth proprietary platform based on artificial intelligence to support inhalation therapy. The aim of the Kata® app for patients is to optimize the drug inhalation therapy of chronic lung diseases through digital support. Clinical evidence shows that patients frequently fail to correctly perform their necessary and regular inhalation due to a lack of therapy adherence or knowledge. As a result, the prescribed medications are not adequately delivered to the respiratory airways. A multitude of different devices for drug inhalation increases the training effort for physicians and patients and makes therapy monitoring almost impossible. This issue affects around 250 million people worldwide suffering from chronic lung diseases to whom Kata® could bring urgently needed relief. Kata® is a proprietary platform application providing a completely novel and unique combination of artificial intelligence and computer animation – it is one of the first digital applications to have received medical device certification.
A modified Kata® app for clinical trials (Kata® Clinical) combines data and patient management to enhance the participants’ experience and improve study outcomes at the same time. Based on the customized adaptation to the specific needs of a study, data collection and management can be conducted more efficiently and are less error-prone due to automation. www.kata-inhalation.com
About sterna biologicals
sterna biologicals GmbH & Co. KG is an innovative clinical-stage immunology company developing novel treatments for chronic inflammatory diseases such as asthma, chronic obstructive pulmonary disease (COPD), atopic dermatitis, and ulcerative colitis. By targeting transcription factors that play a central role in regulating inflammatory mechanisms, the Company’s proprietary DNAzyme-based drug candidates can intervene with key inflammatory processes to address related diseases more effectively. So far, sterna has advanced four programs into Phase 2 development. For more information, please visit www.sterna-biologicals.com.
Dr. Sabine Häußermann | CEO | +49 151 701 865 89 | email@example.com
VisionHealth GmbH | Landsberger Str. 72 | 80339 München | Germany
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Katja Arnold / Dr. Brigitte Keller
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 Press VG et al. J Gen Intern Med. 2011; 26:635-42. https://doi.org/10.1007/s11606-010-1624-2
 The Inhaler Error Steering Committee. Respir Med. 2013; 107:37-46. https://doi.org/10.1016/j.rmed.2012.09.017
 Price DB et al. J Allergy Clin Immunol Pract. 2017; 5:1071-1081.e9. https://doi.org/10.1016/j.jaip.2017.01.004
 Molimard M et al. Eur Resp J. 2017; 49:1601794; https://doi.org/10.1183/13993003.01794-2016
 Lindh A et al. Nursing Open 2019; 6:1519–1527; https://doi.org/10.1002/nop2.357
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 867249