- Meeting included international key opinion leaders
- Input provided on SB012 development plan and phase IIb trial protocol
MARBURG, GERMANY / ACCESSWIRE / March 18, 2019 / Sterna biologicals GmbH & Co. KG ("sterna"), an innovative clinical-stage immunology company developing novel treatments for chronic inflammatory diseases, today announced that the company held a Scientific Advisory Board (SAB) meeting to evaluate the phase IIb clinical development program for SB012 in ulcerative colitis (UC). SB012 is based on sterna's proprietary and patent-protected active pharmaceutical ingredient, hgd40, a DNAzyme and first-in-class GATA-3 antagonist. The SAB meeting was held on March 7, 2019 during the 14th Congress of ECCO (European Crohn's and Colitis Organisation) in Copenhagen, Denmark.
At the SAB meeting, the clinical development program for SB012 in ulcerative colitis, particularly the design of the phase IIb study was discussed and further solidified. Prof. Dr. med. Harald Renz, Co-founder and chairman of sterna biologicals and member of the Company's Scientific Advisory Board, commented: "We have seen promising phase IIa clinical results with SB012 and are now advancing this program into the next stage of clinical development. Our Scientific Advisory Board has provided us with valuable input on the design of our phase IIb study with SB012, which we are now incorporating into the trial protocol in preparation for meetings with regulatory authorities, which we expect to hold later this year."
SB012, a DNAzyme and first-in-class GATA-3 antagonist was tested with an enema formulation of hgd40. For further clinical development (i.e. phase IIb and phase III) and commercialization, an oral formulation of SB012 is being developed.
GATA-3 is the master transcription factor regulating Th2-driven inflammatory diseases such as ulcerative colitis, atopic dermatitis, eCOPD and asthma. By inhibiting GATA-3, the expression of downstream cytokines, interleukin IL-4, IL-5, and IL-13, which cause inflammation, is down regulated. In pre-clinical and clinical development, SB012 was found to be well tolerated with first signs of efficacy. DNAzymes are single-stranded DNA molecules comprising a central catalytic domain flanked by two binding domains. The binding domains attach to a specific sequence of targeted mRNA, such as GATA-3 mRNA in the case of SB012. After binding to the target, the catalytic domain then cleaves the mRNA, thereby inhibiting relevant downstream cytokine expression.
PHASEIIa RESULTS - ULCERATIVE COLITIS
The SECURE study was a prospective, multi-center, randomized, double-blind, placebo-controlled trial that enrolled a total of 20 patients with moderate to severe ulcerative colitis. SB012 was safe and well tolerated and led to marked clinical and endoscopic improvement in patients with active ulcerative colitis. At day 28, there was a statistically significant improvement in the Mayo Score in the SB012 group compared with the placebo group (p=0.04). Clinical remission, clinical response, mucosal healing rates and endoscopic response at days 28 and 56 were also assessed.
ABOUT STERNA BIOLOGICALS
Sterna biologicals GmbH & Co. KG is an innovative 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 Th1- and Th2-driven inflammatory mechanisms, the Company's proprietary DNAzyme-based drug candidates can intervene with upstream inflammatory processes to address related diseases more effectively. Sterna currently has four programs in phase II development.
For more information, please visit www.sterna-biologicals.com.
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SOURCE: sterna biologicals GmbH & Co. KG