STERNA BIOLOGICALS RECEIVES APPROVAL FOR INNOVATIVE PHASE II STUDY IN ASTHMA COMBINING NEW ANTISEN-BASED TREATMENT WITH DIGITAL THERAPY

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DGAP-News: sterna biological GmbH & Co. KG / Keyword (s): Miscellaneous
23.11.2021 / 14:00
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STERNA BIOLOGICALS RECEIVES APPROVAL FOR INNOVATIVE PHASE II STUDY IN ASTHMA COMBINING NEW ANTISEN-BASED TREATMENT WITH DIGITAL THERAPY

– Phase IIa proof of concept (POC) study with the novel antisense catalytic oligonucleotide SB010 in patients with moderate to severe asthma initiated.

– Innovative study design combines pharmacological therapy with Kata from VisionHealth(R) Clinique, a unique combination of artificial intelligence and computer animation to improve patient device handling and adhesion, reduce abandonment rates and generate highly reliable data with reduced inter-patient variability

Marburg, Germany, November 23, 2021 – sterna organics GmbH & Co. KG (sterna), an innovative clinical-stage immunology company developing novel biological treatments for chronic inflammatory diseases, today announced the approval of its clinical trial application (CTA ) by the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) to conduct a Phase IIa Proof of Concept (POC) study with its lead compound SB010, an inhaled liquid formulation of a type special catalytic antisense oligonucleotide, in patients with moderate to severe asthma. For the first time, sterna will combine pharmacological and digital therapy by integrating Kata from VisionHealth(R) Clinical in the trial with the aim of optimizing device handling and adherence to inhalation treatments. The reduction in inhaler usage errors should reduce the variability between patients and, in addition, the Kata’s journal function.(R) Clinical App collects relevant safety data and can provide real-time feedback to the investigator. The combination of these functions specifically tailored to the study design will ensure optimal reliability and meaning of the data. The trial will reveal efficacy data for SB010 in patients with moderate to severe uncontrolled asthma in addition to standard therapy, i.e. despite regular use of inhaled corticosteroids (ICS) and long-acting beta2 agonist (LABA) therapy.

“We are delighted to begin our Phase IIa proof of concept trial with SB010 in patients with moderate to severe uncontrolled asthma before the end of this year. Using VisionHealth’s Kata(R) The clinical results of this trial allow us to reduce the variability between patients by optimizing the handling of the inhaler and thus maximizing the relevance and reliability of the data, ”said Dr. Marion Wencker, Scientific Director of Sterna Biologiques.

Kata(R) Clinical offers a tool to directly inform study centers about relevant patient events, allowing centers to supervise and monitor patients in real time.

POC Phase IIa Study with SB010 in Patients with Moderate to Severe Uncontrolled Asthma Builds on Compelling Principle Evidence in Mild Asthmatics

In an allergen challenge model used in a multicentre, phase IIa, randomized, double-blind, placebo-controlled trial, inhalation of SB010 resulted in a statistically significant reduction in lung function decline compared to placebo both in early and late phase. asthmatic response. [Krug et al., New Engl J Med. (2015)]. Treatment with SB010 was safe and well tolerated. The Company’s Phase IIa POC study with SB010 in patients with moderate to severe asthma began in the fourth quarter of 2021.

The Sterna Phase IIa proof-of-concept trial is designed as a randomized, placebo-controlled trial in which patients with uncontrolled moderate to severe asthma are treated with inhaled SB010 once daily. Efficacy will be assessed by the change in type 2 inflammation in the airways and airway hyperresponsiveness. The results are expected in late 2022 to early 2023.

ABOUT STERNA BIOLOGICALS
sterna biological GmbH & Co. KG is an innovative clinical-stage immunology company developing new 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 the regulation of inflammatory mechanisms, the Company’s proprietary DNAzyme-based drug candidates can intervene in key inflammatory processes to more effectively treat associated diseases. So far, sterna has advanced four programs in the development of phase 2.

For more information, please visit www.sterna-biologicals.com

Sterna’s approach: down-regulating GATA-3 to reduce expression of key inflammatory cytokines
Sterna’s unique new approach to down-regulating GATA-3 with the company’s proprietary active pharmaceutical ingredient, hgd40, a special type of catalytic antisense oligonucleotide – a DNAzyme – could provide a whole new, first of its category, broad spectrum, non-steroid therapy, anti-inflammatory. The down-regulation of GATA-3 leads to reduced expression of several key inflammatory cytokines and thus to the normalization of deregulated type 2 immunity (immunomodulation). Therefore, the company’s SB010 and SB012 therapies containing hgd40 treat multiple inflammatory processes simultaneously and rebalance a deregulated overall immune response. Broad-spectrum topical therapies such as SB010 and SB012 therefore make it possible to treat type 2 inflammatory diseases safely and effectively such as sterna already demonstrated in previous clinical studies.

About VisionHealth
VisionHealth GmbH is a pioneer in digital therapy support for respiratory diseases. The company develops innovative and unique digital health solutions enabling lasting improvements to existing standard treatment for patients with chronic lung diseases such as asthma and COPD. www.visionhealth.gmbh

CONTACT

organic sterna GmbH & Co. KG
Christian Pangratz
Chief Executive Officer
[email protected]

organic sterna GmbH & Co. KG
Bismarckstrae 7
35037 Marburg
Phone. : +49 (0) 6421.98 30 05 0

For media inquiries:
Anne Hennecke / Vera Lang
MC Services SA

[email protected]
Phone. : +49 (0) 211.52 92 52 15

23.11.2021 Distribution of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
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