SG-5-00455, the Company’s development candidate for the treatment of IBD, aims to restore mucosal healing by targeting PAI-1/2
BRISBANE, Calif. – February 24, 2022 – Second Genome, a biotechnology company that leverages its proprietary platform to discover and develop precision therapies and biomarkers, yesterday hosted a virtual key opinion leader (KOL) event focused on the role of mucosal healing and plasminogen activator inhibitor (PAI)-1/2 in inflammatory bowel disease (IBD), and a briefing on SG-5-00455, the Company’s development candidate for the treatment of IBD.
“Following Second Genome’s recent announcement on our nomination of SG-5-00455 to target PAI-1/2 for the treatment of IBD, we were pleased to host leading experts, Drs. Ryan Balfour Sartor and Silvio Danese, to discuss the importance of mucosal healing and targeting PAI 1/2,” said Karim Dabbagh, Ph.D., President and Chief Executive Officer of Second Genome. “Their clinical perspectives on the need for novel, combination, personalized and targeted treatment approaches for IBD patients that aim to drive superior treatment outcomes through increased long-term mucosal healing reinforce the urgency with which we are working to advance SG-5-00455, now in investigational new drug (IND)-enabling studies.”
Addressing critical unmet needs in IBD through a novel approach that targets mucosal healing
The event included a presentation and a Q&A panel with renowned experts in the field, Ryan Balfour Sartor, M.D., Midgette Distinguished Professor of Medicine, Microbiology and Immunology and Co-Director of the University of North Carolina Multidisciplinary Center for IBD Research and Treatment, and Silvio Danese, M.D., Ph.D., Director, Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and Professor of Gastroenterology at the University Vita-Salute San Raffaele in Milan, Italy.
They underscored the importance of mucosal healing in IBD and some of the key factors that regulate gastrointestinal homeostasis.
Remarked Dr. Balfour Sartor: “Clinically, I have several goals of therapy in IBD, including to induce sustained remission with mucosal healing, improve patients’ quality of life and limit disease- and medication related complications. Mucosal healing is associated with better long-term clinical outcomes in ulcerative colitis and Crohn’s disease and is now a U.S. Food and Drug Administration (FDA) metric for clinical trial outcomes. There are multiple strategies to target mucosal healing, and I believe this approach should improve the management of IBD patients.”
Commented Dr. Danese: “In our clinical practice, we see IBD as a very complex illness, and there is an opportunity to better align treatments with this reality. When we think about the future of treatment, it will be important to target the disease at the right stage, with the right drug, because the pathology is likely evolving throughout disease progression. Additionally, there is value in exploring a combination treatment approach to achieve a more profound control of inflammation.”
SG-5-00455’s potential to become a first-in-class precision therapeutic directly targeting mucosal healing in IBD patients
This event follows the Company’s presentation of new pre-clinical data during a digital oral presentation at the 17th Congress of European Crohn’s and Colitis Organization (ECCO) held virtually February 16–19, 2022. Results demonstrated SG-5-00455 improves barrier function and promotes tissue repair through direct binding and modulation of PAI-1/2, and strong precision medicine potential to identify the target patient population using PAI-1/2 pathway biomarker(s). The presentation, “DOP54: Identification and development of a 1st in class naturally-derived protein that drives mucosal healing and is orally delivered by an engineered cellular therapy targeting the gastro-intestinal tract,” can be found here, and the summary press release here.
A replay of the presentation is accessible on the Events page of the Second Genome website at www.secondgenome.com/events/.
SG-5-00455, the Company’s development candidate targeting PAI-1/2 for the treatment of IBD, represents a potential first-in-class precision therapy for IBD by directly improving tissue repair and mucosal healing in IBD patients. The development candidate was generated using a novel, naturally derived protein (SG-2-0776), that was subsequently engineered into a Lactococcus lactis (L. lactis) drug delivery system, SG-5-00455, for direct, non-systemic delivery to the gut. SG-5-00455 is currently in IND-enabling studies, and the Company expects to submit an investigational new drug application (IND) to the U.S. Food and Drug Administration (FDA) in the second half of 2022.
About Second Genome
Second Genome is a biotechnology company that leverages its proprietary technology-enabled platform to discover and develop transformational precision therapies based on novel microbial genetic insights. We built a proprietary drug discovery platform with machine-learning analytics, customized protein engineering techniques, phage library screening, mass spec analysis and CRISPR, that we couple with traditional drug development approaches to progress the development of precision therapies for wide-ranging diseases. Second Genome is advancing lead programs in IBD and cancer into IND-enabling studies. We also collaborate with industry, academic and governmental partners to leverage our platform and data science capabilities. We hold a strategic collaboration with Gilead Sciences, Inc., utilizing our proprietary platform and comprehensive data sets to identify novel biomarkers associated with clinical response to Gilead’s investigational medicines. We also hold a strategic collaboration with Arena Pharmaceuticals to identify microbiome biomarkers associated with clinical response for their lead program in gastroenterology, etrasimod. For more information, please visit www.secondgenome.com.