DGAP-News: sterna biologicals GmbH & Co. KG / Key word(s): Miscellaneous
12.03.2019 / 14:00
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STERNA BIOLOGICALS HOLDS SCIENTIFIC ADVISORY BOARD MEETINGS TO ADVANCE PHASE IIb CLINICAL DEVELOPMENT PROGRAM OF SB010 IN ASTHMA
Marburg, Germany, March 12, 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 two Scientific Advisory Board (SAB) meetings to evaluate the phase IIb clinical development program for SB010 in asthma. SB010 is an inhaled formulation of sterna’s proprietary and patent-protected active pharmaceutical ingredient hgd40, a DNAzyme and first-in-class GATA-3 antagonist. The first SAB meeting took place on February 23, 2019, during the 2019 American Academy of Allergy Asthma & Immunology (AAAAI) Annual Meeting in San Francisco, California, USA and the second meeting was held in Frankfurt/Main, Germany on March 4, 2019. The meetings were attended by asthma key opinion leaders from the U.S. and Europe.
At the SAB meetings, the clinical development program for SB010 in asthma, particularly the design of the phase IIb study in uncontrolled, moderate to severe asthma, 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 received valuable input from our Scientific Advisors on the design of our phase IIb study with SB010. This enables us to bring our SB010 development program to the next level and validate hgd40 also in phase IIb as an innovative, safe and effective therapeutic option in moderate to severe type2-driven asthma. We are now incorporating the feedback into the trial protocol and are planning to next discuss our plans with regulatory authorities.”
Recently, Sterna has also successfully completed in vitro device evaluation studies with SB010 to enable the selection of the most optimal hand-held inhalation systems for late-stage clinical development and commercialization of SB010.
In terms of next steps, sterna is planning to meet with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to gain their input and advice on the final design of the phase IIb development program of SB010.
Sterna biologicals’ drug candidate SB010 is an inhaled formulation of hgd40, a first-in-class GATA-3 antagonist.
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, hgd40 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 hgd40. After binding to the target, the catalytic domain then cleaves the mRNA, thereby inhibiting relevant downstream cytokine expression.
PHASE IIa RESULTS – ASTHMA
In a randomized, double-blind, placebo-controlled parallel group, multi-center phase IIa trial, SB010 led to a significant improvement in lung function in both early (immediate reaction post allergenic exposure, EAR) and late phase (3-8 hours post allergic exposure, LAR) asthmatic response. SB010 attenuated the decline in mean LAR under the FEV curve (AUC) by 34% (decline in median LAR AUC attenuated by 48%) compared to a 1% worsening in mean lung function in the placebo group (p=0.02). SB010 also attenuated the decline in mean EAR AUC by 11% (decline in median EAR AUC attenuated by 15%) compared to a 10% worsening in mean lung function in the placebo group (p=0.03). SB010 was safe and well tolerated. No serious treatment emergent adverse events occurred in either treatment group.
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 2 development.
For more information, please visit www.sterna-biologicals.com.
sterna biologicals GmbH & Co. KG
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