GSK Acquires Global License for Empirico’s Phase I siRNA Candidate EMP-012 Targeting Novel Inflammatory Pathway in COPD

GSK Acquires Global License for Empirico’s Phase I siRNA Candidate EMP-012 Targeting Novel Inflammatory Pathway in COPD

(IN BRIEF) GSK has signed an exclusive global licensing agreement with Empirico Inc. for EMP-012, a first-in-class siRNA candidate currently in Phase I trials for chronic obstructive pulmonary disease (COPD). EMP-012 targets a distinct inflammatory pathway, offering potential therapeutic benefit across the full COPD spectrum, including non-type 2 inflammation where few options exist. The drug’s enhanced potency and extended dosing interval complement GSK’s broad respiratory pipeline. Empirico will complete Phase I before transferring development to GSK, which will handle global commercialization. The deal includes $85 million upfront, up to $660 million in milestone payments, and tiered royalties. Both companies see EMP-012 as a breakthrough step toward precision medicine in respiratory care.

(PRESS RELEASE) LONDON, 28-Oct-2025 — /EuropaWire/ — GSK plc (LSE/NYSE: GSK) and Empirico Inc., a clinical-stage biotechnology company specializing in genetics-based drug discovery and siRNA therapeutics, have entered into an exclusive global licensing agreement for EMP-012, a highly selective, first- and potentially best-in-class siRNA candidate currently in Phase I clinical development for chronic obstructive pulmonary disease (COPD). The asset also holds promise for other inflammatory respiratory diseases.

Under the terms of the agreement, GSK gains full worldwide rights to develop and commercialize EMP-012. Empirico will lead the ongoing Phase I trial before transferring development responsibilities to GSK, which will then oversee global regulatory submissions and commercialization. Financial terms include an $85 million upfront payment and up to $660 million in milestone payments tied to development, regulatory, and commercial achievements, alongside tiered global royalties on net sales.

EMP-012 represents a novel therapeutic approach targeting a distinct inflammatory pathway implicated in COPD progression. Unlike existing treatments, its mechanism of action is independent of baseline type 2 inflammation, smoking status, or comorbidities, potentially extending benefits to patient populations underserved by current biologic therapies. Backed by robust human genetic and translational data, the molecule’s design leverages Empirico’s proprietary siRNA chemistry, offering enhanced potency and extended dosing intervals.

“With EMP-012, we’re advancing our ambition to transform care in COPD by addressing underlying drivers of disease with data-driven innovation,” said Kaivan Khavandi, Senior Vice President and Global Head of Respiratory, Immunology & Inflammation R&D at GSK. “This candidate’s expected long-acting profile and novel mechanism complement our broad COPD pipeline of inhaled, biologic, and genetic therapies, helping us reach patients across the full disease spectrum.”

EMP-012’s development addresses a significant unmet need. Despite recent advances, COPD remains a leading cause of morbidity and mortality worldwide, affecting an estimated 600 million people by 2050 and contributing to escalating healthcare costs projected to reach $4 trillion globally. Current treatments primarily focus on symptom management, leaving patients with non-type 2 inflammation limited therapeutic options and continued risk of exacerbations and hospitalizations.

Oligonucleotide therapies, such as siRNAs, can modulate gene expression directly, enabling the treatment of conditions not easily addressed by traditional small molecules or biologics. EMP-012 thus strengthens GSK’s growing portfolio of oligonucleotide-based therapies across respiratory, immunology, inflammation, and infectious diseases.

“This collaboration validates the power of Empirico’s genetics-driven discovery platform and siRNA expertise to generate high-value, differentiated clinical programs,” said Omri Gottesman, CEO and President of Empirico. “Partnering with GSK allows us to accelerate EMP-012’s development and realize its potential as a transformative precision medicine for COPD and other inflammatory lung diseases.”

With this partnership, GSK continues to expand its leadership in respiratory innovation, combining data-driven target discovery with cutting-edge molecular approaches to address complex inflammatory pathways and improve long-term patient outcomes.

Media contact:
Email: corporate.media@gsk.com
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SOURCE: GlaxoSmithKline plc