News & EventsSTERNA BIOLOGICALS
sterna biologicals announces dosing of first patient in phase IIA proof-of-concept study with SB010 in moderate to severe asthma
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 receives approval for innovative phase II a study design in asthma combining a novel antisense-based treatment with a digital therapy
Marburg, Germany, November 23, 2021
- Phase IIa proof-of-concept (POC) study with novel catalytic antisense oligonucleotide SB010 in patients with moderate to severe asthma initiated.
- Innovative study design combines pharmacological therapy with VisionHealth’s Kata® Clinical, a unique combination of artificial intelligence, and computer animation to enhance patients’ device handling, adherence, reduce drop-out rates and generate maximally reliable data due to reduced inter-patient variability
sterna biologicals raises further EUR 10.0 million (approx. USD 11.9 million) in series A - 2nd closing private placement
Marburg, Germany, January 07, 2021
- Following successful completion of the company’s Series A – 1st closing with EUR 12.0 million in April 2020, sterna now has successfully completed a 2nd closing with another EUR 10.0 million, bringing the Series A total to EUR 22.0 million
- Proceeds from the 2nd closing will fund phase IIb preparatory activities including toxicology studies and CMC work for SB010 in moderate to severe asthma as well as the completion of an oral formulation project for SB012 laying the foundation for phase I/IIb studies in moderate to severe ulcerative colitis
- sterna’s approach to down-regulate master transcription factor GATA-3 using a DNAzyme (enzymatic antisense oligonucleotide) could provide a truly novel, first-in-class, broad-spectrum, non-steroidal, anti-inflammatory therapy across type 2 inflammatory diseases
sterna biologicals GmbH & Co. KG (sterna), an innovative clinical-stage immunology company developing novel biological treatments for chronic inflammatory diseases, today announced that the company has secured EUR 10.0 million (approx. USD 11.9 million) in a 2nd closing of its Series A private placement. Proceeds will fund toxicology and CMC (chemistry, manufacturing and controls) work preparing the company for the initiation of a phase IIb trial with SB010 in patients with moderate to severe asthma. The funds will further be used for the completion of the ongoing oral formulation project for SB012 in preparation of phase I/IIb studies in moderate to severe ulcerative colitis patients.
sterna is currently preparing a phase IIa proof-of-concept study with SB010 in patients with moderate to severe asthma. According to current development plans, sterna expects clinical data from its POC study in 2022 and is planning to start phase IIb development in 2023. In parallel, the company has initiated an oral formulation project for SB012. Once a final oral formulation candidate is available, phase I/IIb studies could start as early as in the first half of 2023.
“We thank our investors for their continuous support and strong vote of confidence in our highly promising treatment approach as well as our comprehensive non-clinical and clinical data package. Their financial commitment enables us to pursue the most rapid development scenario for SB010 in moderate to severe asthma and SB012 in moderate to severe ulcerative colitis”, said Christian Pangratz, Chief Executive Officer of sterna biologicals.
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.
Phase IIa proof-of-concept (POC) study with SB010 in patients with moderate to severe asthma to be initiated – building on compelling proof-of-principle data in mild asthmatics
sterna is preparing a phase IIa POC study with SB010 in patients with moderate to severe asthma. The company expects clinical data in 2022 and is planning to start phase IIb development in 2023.
In a randomized, double-blind, placebo-controlled parallel group, multi-center phase IIa proof-of-principle 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.
Oral formulation of SB012 for patients with moderate to severe ulcerative colitis - optimizing administration
sterna is currently developing an oral formulation of hgd40 to be used in phase I/IIb clinical development with patients suffering from moderate to severe ulcerative colitis. First feasibility work was successfully completed, and the company is now in the process of finalizing a novel colon-targeting drug product candidate leveraging commercially validated technology.
In a prospective, multi-center, randomized, double-blind, placebo-controlled phase IIa POC trial with moderate to severe ulcerative colitis patients, rectal administration of SB012 was well tolerated and lead to marked clinical and endoscopic improvement.