GSK licences siRNA COPD drug in US$745m biobucks deal

British GlaxoSmithKline plc (GSK) has entered a US$745m licensing agreement with Empirico Inc for EMP-012, a first-in-class siRNA candidate for COPD. EMP-012 targets the underserved non-type 2 inflammation segment, such as neutrophilic COPD. This form of COPD is characterised by persistent airway neutrophil-driven inflammation and limited response to corticosteroids. The global market opportunity for therapies addressing this segment is estimated at US$600–700bn.

According to GSK, EMP-012 is a highly selective siRNA candidate that modulates key inflammatory pathways. Its activity is independent of baseline type 2 inflammation, smoking status, or co-morbid conditions. EMP-012 is currently in Phase I trials. Empirico holds patents on GalNAc-conjugated siRNAs (US11879125B2), designed to improve tissue delivery and prolong half-life. Other claims regarding potency, stability, and delivery remain corporate publicity and are unverified.

First-in-class siRNA pipeline

EMP-012 represents a precision-targeted oligonucleotide approach. Empirico uses its proprietary and confidential siRCH™ chemistry platform together with the Precision Insights Platform™ to design and optimise siRNAs. The platform incorporates chemical stabilisation and targeted conjugation, including GalNAc (US11879125B2), to improve delivery and half-life. Other details of the siRCH™ platform remain confidential and publicity unverified. EMP-012 can be used as monotherapy or in combination across GSK’s respiratory pipeline.

Competitive landscape

EMP-012 faces competition from RNA-based and biologic therapies for COPD:

• Silence Therapeutics: siRNA candidates targeting inflammatory pathways in COPD, preclinical to early clinical stage.

• AstraZeneca: Inhaled anti-inflammatory biologics, primarily targeting type 2 inflammation.

• Novartis: Small molecule and biologic programmes for COPD exacerbations, including PDE4 inhibitors and novel anti-inflammatory agents.

EMP-012’s potential advantages lie in targeting non-type 2 inflammation and offering flexible monotherapy or combination strategies. Claims regarding potency and half-life beyond the GalNAc patent remain corporate publicity and are unverified.

Deal details

GSK will pay an upfront US$85m and could provide up to US$660m in development, regulatory, and commercial milestones, plus tiered royalties on net sales worldwide. Empirico will continue leading the Phase I clinical trial, after which GSK assumes full responsibility for global development, regulatory filings, and commercialisation.

The agreement might strengthen GSK’s respiratory portfolio in the short term, complementing existing programmes and delivering a positive signal to investors, reflecting Emma Walmsley’s strategy of portfolio optimisation and specialty focus. Simultaneously, it aligns with incoming CEO Luke Miels’ emphasis on pipeline differentiation and innovation. EMP-012 is a first-in-class siRNA targeting an unmet pathophysiological mechanism, representing potential long-term growth for GSK’s respiratory pipeline.