Marburg, Germany, December 14, 2021
- GIANT-1 study to evaluate once-daily oral inhalation of novel catalytic antisense oligonucleotide formulation SB010 in patients with moderate to severe Type-2 driven asthma
- Standard of care remains insufficient for large number of these asthmatics
- Study incorporates digital therapy to enhance patient device handling, increase adherence, reduce drop-out rates and generate maximally reliable data through reduction of inter-patient variability
sterna biologicals GmbH & Co. KG (sterna), a clinical-stage immunology company developing novel biological treatments for chronic inflammatory diseases, today announced that the first patient has been dosed in the Company’s phase IIa proof-of-concept (POC) trial with SB010 in patients with moderate to severe Type-2 driven asthma.
The GIANT-1 (GATA-3 Inhibition in Asthmatics Not controlled on standard medication with Type-2) trial is a randomized, double-blind, multiple-dose, placebo-controlled clinical study investigating the effect of once-daily oral inhalation of SB010, a liquid formulation of a special type of catalytic antisense oligonucleotide that contains human GATA-3-specific DNAzyme hgd40. The study will compare SB010 to placebo in patients with moderate to severe type 2 dominant asthma inadequately controlled by medium-to-high dose inhaled corticosteroids (ICS) and long-acting β2-agonist (LABA) therapy (Global Initiative for Asthma [GINA 2020] treatment step 4 or 5). The primary objective is to evaluate the effect on airway inflammation as measured by the change in the fraction of exhaled nitric oxide (FeNO). The study will also assess the safety and tolerability of repeated orally inhaled doses of SB010 as well as the pharmacokinetics of single and multiple doses of inhaled hgd40 in a subgroup of patients. The study is planned to enroll approximately 100 patients at 18 centers in Germany.
“We are pleased that the first patient has been treated in our GIANT-1 trial with inhaled SB010 in patients with uncontrolled moderate to severe asthma,” said Dr. Marion Wencker, Chief Medical Officer of sterna biologicals. “SB010 has already been shown in early clinical testing in patients with mild asthma to attenuate bronchospasm after allergen challenge compared to placebo in both early and late-phase asthmatic response. We look forward to now evaluating this promising product candidate in more advanced disease.”
“Today, the standard of care treatment regimen for moderate to severe Type 2-driven asthma is not sufficient for a large number of patients, who continue to experience asthma symptoms and exacerbations and, over time, disease worsening,” said Prof. Dr. med. Tobias Welte, Hospital Director of the Clinic of Pneumology at Medizinische Hochschule Hannover and Coordinating Investigator of the GIANT-1 trial. “I am excited about the potential SB010 holds in treating patients with moderate to severe uncontrolled asthma. If shown to be safe and effective, SB010 could offer hope to patients in urgent need of new options, and I look forward to seeing the results from the GIANT-1 trial.”
For the first time, sterna is integrating a digital therapy component to generate maximally reliable data through the reduction of inter-patient variability
In this study, sterna will for the first time, combine pharmacological and digital therapy by integrating VisionHealth’s Kata® Clinical into the trial. The Kata® Clinical patient app is designed to optimize device handling and improve adherence to inhaled treatments and reduce inhaler usage errors, and therefore is expected to reduce inter-patient variability. The diary function of the Kata® Clinical app collects relevant safety data and can provide real-time feedback to participating investigators. The combination of these functions, specifically tailored to the GIANT-1 study design, should then optimize data accuracy.
Results from the trial are expected in late 2022/early 2023.
GIANT-1 study 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 decrease in lung function versus placebo in both early- and late-phase asthmatic response. [Krug et al., New Engl J Med. (2015)]. Treatment with SB010 in this trial was shown to be safe and well tolerated.
ABOUT STERNA BIOLOGICAL
sterna biologicals GmbH & Co. KG is a 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 inflammation, the Company’s proprietary DNAzyme-based drug candidates can intervene with key inflammatory processes to more effectively address related diseases. To date, sterna has advanced four programs into phase II development.
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 therapeutic candidates containing hgd40, SB010 and SB012, address several inflammatory processes simultaneously and rebalance an overall dysregulated immune response. Broad-spectrum topical therapeutics like SB010 and SB012, therefore, may enable the safe and effective treatment of type 2 inflammatory diseases, as demonstrated in early clinical studies.