Sterna biologicals 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 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 special type of catalytic antisense oligonucleotide, in patients with moderate to severe asthma. For the first time, sterna will combine pharmacological and digital therapy by integrating VisionHealth’s Kata^® Clinical into the trial with the goal to optimize device handling and adherence to inhaled treatments.

The Kata^® Clinical App provides relevant safety data and real-time feedback
The reduction in inhaler usage errors is expected to reduce inter-patient variability and in addition, the diary function of the Kata^® 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 data reliability and meaningfulness. The trial will reveal efficacy data of SB010 from patients with uncontrolled moderate to severe asthma on top of standard therapy, i.e. despite regular use of inhaled corticosteroid (ICS) and long-action beta2 agonist (LABA) therapy.

“We are excited to start our phase IIa proof-of-concept trial with SB010 in patients with uncontrolled moderate to severe asthma before the end of this year. Using VisionHealth’s Kata^® Clinical in this trial allows us to reduce inter-patient variability due to optimize inhaler handling and therewith maximizing data meaningfulness and reliability”, said Dr. Marion Wencker, Chief Scientific Officer of sterna biologicals. Kata^® Clinical offers a tool to directly inform study centers about relevant patient events, allowing centers to supervise and monitor patients in real-time.

Phase IIa POC study with SB010 in patients with uncontrolled moderate to severe asthma builds on compelling proof-of-principle data in mild asthmatics
In an allergen challenge model used in a randomized, double-blind, placebo-controlled parallel group, multi-center phase IIa trial the inhalation of SB010 led to a statistically significant attenuation of drop in lung function versus placebo in both 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 started in Q4 2021. Sterna’s Phase IIa proof-of-concept trial is designed as a randomized placebo-controlled trial in which patients with moderate to severe uncontrolled asthma are treated with inhaled SB010 once daily. Efficacy will be assessed by the change in type-2 inflammation in the airways and airway hyperreactivity. Results are expected for late 2022 to early 2023.

Sterna’s approach: Down-regulating GATA-3 to reduce expression of key inflammatory cytokines
sterna’s novel and unique approach to down-regulate GATA-3 with the company’s proprietary active pharmaceutical ingredient hgd40, a special type of catalytic antisense oligonucleotide – a DNAzyme – could provide for a truly novel, first-in-class, broad-spectrum, non-steroidal, anti-inflammatory therapy. Down-regulating GATA-3 leads to a reduced expression of several key inflammatory cytokines and thereby normalization of the dysregulated type 2 immunity (immunomodulation). Consequently, the company’s therapies SB010 and SB012 containing hgd40 address several inflammatory processes simultaneously and rebalance an overall dysregulated immune response. Broad-spectrum topical therapeutics like SB010 and SB012 therefore, allow to treat type 2 inflammatory diseases safely and efficaciously as sterna already demonstrated in previous clinical studies.