Shortly following the announcement of its acquisition of Syndivia’s ADC, GSK entered into a worldwide exclusive license agreement with Empirico for its leading clinical-stage respiratory disease treatment, EMP-012.¹

Kaivan Khavandi, SVP & global head of respiratory, immunology & inflammation R&D at GSK, discussed the license agreement in a press release, saying, “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.”

What is EMP-012?

EMP-012 is a highly selective first-and potentially best-in-class siRNA.¹ The oligonucleotide addresses therapeutic targets, and is currently undergoing a phase I trial for the treatment of chronic obstructive pulmonary disease (COPD), with the potential for expansion into other inflammatory respiratory diseases.¹ EMP-012’s mechanism of action targets a select inflammatory pathway and introduces the potential for a therapeutic approach that is agnostic of baseline type 2 inflammation, smoking, and or co-morbid disease, and its target is supported withgenetic data and translational insight, providing confidence in its potential.¹ Based on its mechanism, EMP-012 hold the potential to offer clinical benefit to patients diagnosed with non-type 2 inflammation, a critical patient sub-group where treatment options are limited. EMP-012 also offers enhanced potency and longer dosing intervals, a result from Empirico’s proprietary siRNA chemistry, and strategically complements GSK’s ongoing programs in COPD, such as long-acting biologics.¹ Additionally, EMP-012 offers GSK a variety of options for combinations across its COPD portfolio and pipeline.

Details of the agreement

Per the terms of the agreement, GSK is granted full worldwide development and commercial rights to EMP-012, with Empirico expected to continue its lead of the clinical development of EMP-012 through the completion of its ongoing phase I clinical trial.¹ Following EMP-012’s completion of its phase I trial, GSK will assume responsibility for worldwide development, regulatory filings, and commercialization. GSK is set to pay an upfront payment valued upwards of $85 million, and up to $660 million in success-based development, regulatory and commercial milestones, along with tiered royalties on net sales worldwide, making the total value of the deal around $745 million.¹

Empirico’s statement on the licensing agreement

Omri Gottesman, CEO and president, Empirico, said, “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.”

Sources

1. GSK and Empirico enter license agreement for clinical-stage, first-in-class oligonucleotide candidate to treat respiratory diseases GSK October 28, 2025 https://www.gsk.com/en-gb/media/press-releases/gsk-and-empirico-enter-license-agreement-for-clinical-stage-first-in-class-oligonucleotide-candidate/