Marburg, Germany, May 26, 2020
- Proceeds to fund next Phase 2 clinical study with SB010 in moderate to severe asthma and oral formulation work for SB012 in ulcerative colitis
- Sterna’s approach to down-regulate master transcription factor GATA-3 using a DNAzyme (enzymatic antisense oligonucleotide) enables broad-spectrum, simultaneous intervention in key type 2 inflammatory processes
- Topical treatment with SB010 and SB012 is expected to become a novel, safe and efficacious therapeutic option for chronic inflammatory diseases with high unmet medical need.
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 12 million (approx. USD 13 million) in a private placement. Both, new and existing investors participated in the financing round.
Proceeds will fund the Company’s next Phase 2 clinical trial with SB010 in moderate to severe asthma, the development of an oral formulation for SB012 for the treatment of moderate to severe ulcerative colitis and related CMC (chemistry, manufacturing and controls) activities. Sterna’s novel and unique approach to down-regulate GATA-3 with the topical DNAzyme hgd40, an enzymatic antisense oligonucleotide, results in the reduction of several key inflammatory cytokines. Consequently, the Company’s therapies SB010 and SB012 containing hgd40 can simultaneously address a number of inflammatory processes and rebalance an overall dysregulated immune response. Broad-spectrum topical therapeutics like SB010 and SB012 can therefore treat type 2 inflammatory diseases safely and efficaciously as Sterna already demonstrated in previous clinical studies.
“We are very pleased with having received such a strong vote of confidence from existing and new investors. Their financial commitment validates Sterna’s highly promising treatment approach and our comprehensive non-clinical and clinical data package. Based on over one thousand administrations of hgd40 in humans, we are well prepared together with the proceeds from this financing to progress SB010 and SB012 through the next phase of clinical and CMC development.”, said Christian Pangratz, Chief Executive Officer of sterna biologicals.
Phase IIa study with SB010 in patients with moderate to severe asthma to be initiated – building on compelling data in mild asthmatics
The Company is preparing to initiate a phase IIa proof-of-concept study with SB010 in patients with moderate to severe asthma. 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 [Krug et al., New Engl J Med. (2015)], local administration of SB010 (hgd40 in solution) led to a statistically significant improvement in lung function versus placebo in both early- and late-phase asthmatic response. SB010 was further shown to be safe and well tolerated.
Oral formulation of SB012 for patients with moderate to severe ulcerative colitis - optimizing administration
Sterna is developing an oral formulation of hgd40 for SB012 for the Company’s planned phase IIb clinical development program in patients with moderate to severe ulcerative colitis. First feasibility work was successfully completed and Sterna is now working with leading oral formulation experts to conduct development activities yielding a novel colon-targeting formulation for use in late stage clinical trials and ultimately commercialization.
In a prospective, multi-center, randomized, double-blind, placebo-controlled phase IIa trial in patients with moderate to severe ulcerative colitis, local administration of SB012, a solution containing hgd40, was well tolerated and lead to marked clinical and endoscopic improvement in patients with active ulcerative colitis.