GSK and Empirico Sign Exclusive Global License Agreement for Novel siRNA Therapy in COPD
GSK plc and Empirico Inc., a clinical-stage biotechnology company specializing in human genetics-driven target discovery and siRNA therapeutics, have entered into a worldwide exclusive license agreement for EMP-012, a first- and potentially best-in-class small interfering RNA (siRNA) candidate.
EMP-012, a highly selective oligonucleotide-based therapy, is currently in Phase I clinical development for the treatment of chronic obstructive pulmonary disease (COPD), with potential applications in other inflammatory respiratory diseases.
Addressing a High Unmet Need in COPD
Despite continuous innovation, COPD remains a major global health challenge.
By 2050, the global COPD prevalence is projected to reach 600 million people, becoming the leading cause of hospital admissions worldwide.
The economic burden is expected to exceed $4 trillion globally.
Given the heterogeneous nature of COPD, there is a pressing need for novel therapeutic strategies to serve patients who do not respond adequately to existing biologics and continue to experience symptoms, exacerbations, and hospitalisations.
A Novel Mechanism Targeting Distinct Inflammatory Pathways
Discovered by Empirico, EMP-012 targets a unique inflammatory pathway, offering a mechanism that is independent of baseline type 2 inflammation, smoking status, or co-morbid conditions.
The target is supported by extensive genetic and translational data, strengthening confidence in its therapeutic potential.
Based on this novel mechanism:
EMP-012 may provide clinical benefit to non-type 2 inflammation patients, a subgroup with limited treatment options.
The therapy’s enhanced potency and extended dosing interval, achieved through Empirico’s proprietary siRNA chemistry, complement GSK’s long-acting biologics and broader COPD research programmes.
Strategic Fit Within GSK’s Respiratory Pipeline
According to Kaivan Khavandi, Senior Vice President and Global Head, Respiratory, Immunology & Inflammation R&D, GSK:
“This agreement reflects our ambition to transform care in COPD by advancing novel targets, backed by data, to address underlying drivers of disease. With its expected long-acting characteristics and ability to target distinct inflammatory pathways, EMP-012 complements our pipeline of diverse modalities in COPD and builds on the current landscape of inhaled and biologic therapeutics in this area of substantial unmet need.”
Expanding GSK’s Oligonucleotide Capabilities
Oligonucleotides such as siRNA therapeutics can selectively modulate gene expression, enabling the targeting of diseases that traditional small molecules or biologics cannot address.
EMP-012 further strengthens GSK’s oligonucleotide portfolio, which spans its respiratory, immunology and inflammation, and infectious diseases therapy areas.
Empirico’s Perspective on the Collaboration
Omri Gottesman, CEO and President of Empirico, commented:
“This collaboration further validates the enormous potential of Empirico’s proprietary target discovery and siRNA platforms to rapidly generate differentiated clinical programs of significant value. GSK’s global reach and deep expertise in COPD will help to accelerate the development of EMP-012, and we look forward to working closely with GSK on advancing a potentially transformative precision medicine for patients with COPD and other inflammatory respiratory diseases.”
Terms of the Agreement
Under the agreement:
GSK obtains full worldwide development and commercial rights to EMP-012.
Empirico will lead the ongoing Phase I trial, after which GSK will take over global development, regulatory submissions, and commercialisation.
Financial terms include an upfront payment of $85 million, with up to $660 million in potential milestone payments, in addition to tiered royalties on global net sales.
About EMP-012
EMP-012 is a highly selective siRNA molecule targeting a novel inflammatory pathway associated with COPD and related respiratory diseases. Its long-acting profile, proprietary chemistry, and genetic validation position it as a potential first-in-class therapy addressing both type 2 and non-type 2 inflammation.
About Empirico Inc.
Empirico is a clinical-stage biotechnology company developing siRNA-based medicines designed to mimic naturally occurring genetic variants that confer beneficial effects on health and disease. The company leverages its human genetics-driven discovery platform to identify novel therapeutic targets and develop precision RNA-based therapies.
About GSK
GSK plc is a global biopharmaceutical company with a mission to unite science, technology, and talent to get ahead of disease together. The company focuses on innovative medicines and vaccines across infectious diseases, immunology, oncology, and respiratory health.
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