PipelineSTERNA BIOLOGICALS

sterna biologicals has successfully completed four phase IIa clinical trials and is progressing towards advanced mid-stage clinical development in the company’s lead indications - asthma and ulcerative colitis.
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SB010 in asthmaHigh unmet need in severe asthma

Current standard of care to control symptoms and reduce exacerbations is treatment with inhaled corticosteroids (ICS), long-acting beta agonists (LABA) and long-acting muscarinic antagonists (LAMA). Unfortunately, the standard of care is not sufficient for a large number of patients as they continue to experience asthma symptoms and exacerbations.
The continuation of insufficient treatment with standard of care leads to disease worsening and progression to biological therapies that only work for certain patients.

This situation leaves physicians, patients and caregivers without a 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.

Inhalating woman

Significantly attenuated asthmatic response

shown in phase II a trial

Our inhaled liquid formulation SB010 leverages sterna´s proprietary and patent-protected active pharmaceutical ingredient hgd40.

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)] responses. Treatment with SB010 was safe and well tolerated.

Currently, we are preparing a phase IIa study with SB010 in patients with moderate to severe asthma.

SB012 in ulcerative colitisHigh unmet need in moderate to severe

Ulcerative Colitis

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.

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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.