SB010 in asthmaHigh unmet need in moderate to severe asthma
Current standard of care to control symptoms and reduce exacerbations in asthmatic patients is treatment with inhaled corticosteroids (ICS) and long-acting beta agonists (LABA). In severe asthma this may be complemented by long-acting muscarinic antagonists (LAMA) and biologicals. Unfortunately, the standard of care treatment regimen for moderate to severe Type 2-driven asthma is not sufficient for a large number of patients as they continue to experience asthma symptoms and exacerbations with significant impact on their quality of life. Insufficient treatment effect with standard of care inhaler drugs leads to the use of systemic corticosteroids and progression to antibody therapies. Side-effects caused by oral corticosteroid regiment are well known and should be avoided and reduced response to antibody therapy leaves a significant proportion of patients with unmet medical needs.
Consequently, physicians, patients and caregivers are without an alternative inhaled non-steroidal broad-spectrum therapy, which is beneficial for all type 2 phenotypes. It further clearly establishes and stresses the need for therapy going beyond the current standard of care in terms of safety and effectiveness.
sterna’s SB010Significantly attenuated asthmatic response
In the GIANT-1 (GATA-3 Inhibition in Asthmatics Not controlled on standard medication with Type-2) trial, a randomized, double-blind, multiple dose, placebo-controlled phase IIa clinical study, we are currently investigating the effect of once-daily oral inhalation of SB010 compared to placebo in patients with moderate to severe asthma. The primary objective of this study 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 safety and tolerability of repeated orally inhaled doses of SB010. In a subgroup of patients, pharmacokinetics of single and multiple doses of inhaled hgd40 will be investigated too.
GIANT-1 study builds on compelling proof-of-principle data in mild asthmatics
In a clinical allergen challenge model used in a randomized, double-blind, placebo-controlled parallel group, multi-center phase IIa trial with mild asthmatics, published in the New England Journal of Medicine, local administration of SB010 led to a statistically significant improvement 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.
SB012 in ulcerative colitisHigh unmet need in moderate to severe
Although, treatment for ulcerative colitis has improved significantly in recent years, there is still no therapeutic option offering safe, long-term remission. As patients often become resistant to current treatments, there is a large need for therapy switching and/or dose-escalation. Patients show primary and secondary non-response or an incomplete response to currently available therapies, which additionally come with serious side effects.
Favorable safety and efficacy
anti-inflammatory profile established
Sterna´s enema formulation SB012 leverages our proprietary and patent-protected active
pharmaceutical ingredient hgd40.
In a prospective, multi-center, randomized, double-blind, placebo-controlled phase IIa trial that enrolled a total of 20 patients with moderate to severe ulcerative colitis, local administration of SB012 was well tolerated and lead to marked clinical and endoscopic improvement.
We are currently developing an oral formulation of hgd40 to be used in phase IIb clinical development in patients with moderate to severe ulcerative colitis. First feasibility work was successfully completed and we are now working with formulation experts on the development of a novel colon-targeting formulation for use in late stage clinical trials and ultimately commercialization.