GSK strikes again, adding COPD candidate in $745m deal

In its second pipeline-expanding deal in the space of 24 hours, GSK has licensed rights to a drug for chronic obstructive pulmonary disease (COPD) from US biotech Empirico for $85 million upfront.

The agreement, which also includes up to $660 million in milestone payments, is focused on a small, interfering RNA (siRNA) candidate against an unspecified target, which according to GSK addresses "a distinct inflammatory pathway with enhanced potency and longer dose intervals."

The drug, called EMP-012, has started phase 1 clinical testing and has been billed as having the potential to treat a broad spectrum of COPD, including patients with non-type 2 inflammation, who have limited treatment options.

That makes it a potential companion drug to GSK's IL-5 inhibitor Nucala (mepolizumab), which had its label extended to include add-on maintenance treatment of adult patients with inadequately controlled COPD and high levels of white cells called eosinophils, which is indicative of type 2 inflammatory response.

Nucala is already a $2.4 billion blockbuster for GSK from its main use in severe asthma, but COPD is expected to be a major growth driver for the drug, given that it is the third leading cause of death worldwide and affects more than 300 million people globally.

Sanofi and Regeneron's IL-4 and IL-13 inhibitor Dupixent (dupilumab) is approved for COPD, but also only in patients whose disease is driven by type 2 inflammation. It is estimated that the majority of cases - perhaps as high as 60% to 80% - are non-type 2.

By 2050, COPD prevalence is expected to increase to about 600 million people and become the leading cause of all hospital admissions, costing healthcare systems approximately $4 trillion, according to GSK.

Omri Gottesman, chief executive and president of San Diego-based Empirico, said that the GSK deal will help to accelerate the development of EMP-012 and "validates the enormous potential of Empirico's proprietary target discovery and siRNA platforms to rapidly generate differentiated clinical programmes of significant value."

Empirico will lead the development of the drug through the completion of the current phase 1 study, with GSK taking it forward thereafter. In addition to Nucala, GSK is running phase 3 trials of long-acting IL-5 inhibitor depemokimab in COPD and also has an anti-IL-33 antibody (GSK3862995) in early-stage clinical development.

Yesterday, GSK added a new antibody-drug conjugate to its cancer pipeline via a $358 million agreement with French biotech Syndivia.