GSK’s respiratory pipeline adds early-stage drug offering new approach to COPD

GSK’s respiratory medicine portfolio includes a newly approved product for chronic obstructive pulmonary disease as well as therapeutic candidates in various stages of clinical development for the treatment of this prevalent lung disease. The pharmaceutical giant is now adding another to its pipeline, paying $85 million to secure the rights to an early-stage drug that brings a new approach to COPD.

The drug comes from San Diego-based Empirico, a startup that discovers and develops small interfering RNA (siRNA) therapies. Drugs in this class of drugs exploit RNA interference to reduce gene expression of a disease-causing protein. Empirico’s medicines are derived from proprietary technologies, one for the discovery of genetically validated targets and the other for the discovery and development of siRNA drugs. The target of Empirico’s COPD drug candidate, EMP-012, has not been disclosed.

GSK has a long history in respiratory medicines. Its lead respiratory product is Trelegy, an inhaled combination therapy approved for asthma and COPD. The drug generated sales of £2.7 billion (around $3 billion) last year. Nucala, an antibody designed to inhibit the pro-inflammatory signaling protein IL-5, was initially approved in 2015 for the treatment of severe asthma. The monthly injection is also a commercial success, accounting for £1.7 billion (about $2.2 billion) in revenue in 2024 across all of its approved indications.

COPD is the last approved use of Nucala. The FDA’s approval in May in this indication allows the GSK product to remain competitive with Dupixent, the blockbuster antibody drug from Sanofi and Regeneron Pharmaceuticals that last year became the first biologic drug approved for COPD. Like Dupixent’s COPD regulatory green light, the FDA’s new approval of Nucala specifically covers patients whose COPD is characterized by high levels of eosinophils, a type of white blood cell. An excessive eosinophil immune response leads to what is called type 2 inflammation. It is estimated that 40% of COPD patients suffer from disease due to type 2 inflammation. Empirico’s EMP-012 offers the opportunity to help others.

Without disclosing details about EMP-012’s target, GSK said the drug attacks a distinct inflammatory pathway. The company added that the target is “supported by extensive genetic data and translational information, providing confidence in its potential.” Beyond tackling a new target, GSK said Empirico’s drug offers improved potency and a longer dosing interval, although that interval was not specified.

GSK said Empirico’s drug could be used as a monotherapy and in combination with assets in its COPD portfolio and pipeline. This pipeline includes the IL-5 drug depemokimab. This long-acting antibody is designed to be administered every six months. An antibody targeting IL-33, GSK3862995, is in phase 1 testing.

Announcing the deal on Tuesday, Kaivan Khavandi, senior vice president and global head of GSK’s Respiratory, Immunology and Inflammation practice, said the deal reflected the pharmaceutical company’s goal to advance new targets that address the underlying drivers of disease.

“With its expected long-acting characteristics and ability to target distinct inflammatory pathways, EMP-012 complements our portfolio of diverse COPD treatment modalities and builds on the current landscape of inhaled and biologic therapies in this area of ​​high and unmet need,” he said.

Under the terms of the agreement, GSK obtains full global development and commercial rights to the EMP-012. Empirico will complete ongoing phase 1 testing of the drug; GSK is responsible for continued clinical development, regulatory submissions and, if approved, commercialization. Beyond the $85 million upfront payment, the agreement allows Empirico to receive up to $660 million in development, regulatory and commercial milestone payments. If EMP-012 comes to market, Empirico will receive royalties on GSK’s net worldwide sales of the product.

Illustration: CIPhotos via Getty Images