DGAP-News: VisionHealth GmbH / Key word(s): Agreement
VisionHealth's Kata(R) Clinical app to support sterna biologicals' clinical Phase IIa asthma trial
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(R) Clinical is implemented into sterna biologicals GmbH & Co. KG's (sterna) Phase IIa 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(R) Clinical also beyond this trial.
Kata(R) Clinical is a modified Kata(R) 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(R) 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(R) 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(R) 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(R) Clinical in our proof-of-concept trial for SB010 in asthma. Kata(R) 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(R) Clinical will support our study participants with a fascinating combination of artificial intelligence and computer animation."
Kata(R) 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 %.,,,, 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(R) Clinical trains the patient and controls the therapeutic inhalation, thus delivering trustworthy and consistent results.
A modified Kata(R) 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.
About sterna biologicals
23.11.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.