GSK pens $745M deal for phase 1 drug that hits sweet spots of COPD, oligonucleotides

GSK’s antibody-drug conjugate strategy may be making more headlines recently, but the British pharma hasn’t forgotten about oligonucleotides.

The drugmaker is paying $85 million upfront to Empirico for the rights to a siRNA oligonuceleotide dubbed EMP-012 that’s already in a phase 1 study for chronic obstructive pulmonary disease (COPD). The candidate has “best-in-class” potential, according to GSK, which hopes to broaden EMP-012’s use to other inflammatory respiratory diseases.

The oligonclueotide targets a specific inflammatory pathway that has “potential for a therapeutic approach that is agnostic of baseline type 2 inflammation, smoking or co-morbid disease,” GSK said in an Oct. 28 release.

The aim is to focus the asset on patients with non-type 2 inflammation, which the pharma described as a “key patient sub-group where treatment options are limited.”

As well as the upfront payment, GSK could ultimately pay out up to $660 million in development, regulatory and commercial milestone payments as well as tiered royalties on sales if EMP-012 makes it to market.

GSK placed EMP-012 in the context of the pharma’s wider COPD efforts. As well as scoring an approval for Nucala in the respiratory condition this year, the drugmaker also picked up a PDE3/4 inhibitor from China’s Hengrui Pharma in July that the British company said at the time “supports GSK's ambition to treat patients across the widest spectrum of COPD.”

Kaivan Khavandi, M.D., Ph.D., GSK’s global head of respiratory, immunology and inflammation R&D, said the agreement with Empirico “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,” Khavandi added.

Over the years, Empirico has penned collaborations with the likes of Ionis Pharmaceuticals and Abcellera. The San Diego-based biotech’s CEO Omri Gottesman said the deal with GSK “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,” Gottesman added.

GSK is itself no stranger to oligonucleotides, short strands of synthetic DNA or RNA that can reduce, restore or modulate RNA through several different mechanisms. 

GSK’s oligonucleotide pipeline is led by bepirovirsen, a collaboration with Ionis Pharmaceuticals that is now in a pair of phase 3 trials as a potential “functional cure” for hepatitis B virus infection. The oligo portfolio also includes a collaboration with Arrowhead Pharmaceuticals for fatty liver disease, various assets acquired from Wave Life Sciences and a nonexclusive license to Elsie Biotechnologies’ platform.