AstraZeneca (AZ) has entered an exclusive license agreement with Aridis Pharmaceuticals for its late-stage monoclonal antibody (mAb) candidate suvratoxumab.
Under the terms of the deal, AZ will receive an upfront payment of $11m from Aridis, and will also be eligible to receive a further $115m dependent on the achievement of certain development and sales-related milestones in addition to tiered royalties on net sales.
Suvratoxumab is ready for phase 3 clinical evaluation for the prevention of pneumonia – in phase 2, the mAb showed a 47% relative reduction of pneumonia in S. aureus colonised, mechanically ventilated patients under the age of 65 years old.
This also corresponded with a reduction in the number of days patients needed in ICU and hospital.
Previous data, published in the Lancet Infectious Diseases in June, suggested that the mAb was not effective at reducing pneumonia caused by Staphylococcus aureus in the ICU setting, based on an analysis of the entire trial population of 767 patients.
“We are pleased to have been selected as AstraZeneca’s licensee. The strong data from the phase 2 trial gives us an advantage to define the patient population, primary endpoint, and the phase 3 clinical study design to support a clear path to the Phase 3 confirmatory trial,” said Vu Truong, chief executive officer of Aridis.
“Suvratoxumab has the potential to transform pulmonary infection management in ventilated patients. We are pleased to complete this licensing deal with Aridis who we believe are well placed to take suvratoxumab forward,” added Mark Esser, vice president, microbial sciences, BioPharmaceuticals R&D at AZ.
Aridis is planning to launch the phase 3 study of suvratoxumab in the fourth quarter of this year – the company will receive up to €25m from the European Commission’s (EC) Innovative Medicines Initiative (IMI) COMBACTE clinical trial consortium for this trial.
Aside from suvratoxumab, Aridis is testing another mAb – known as AR-301 – as a therapeutic treatment for S. aureus pneumonia in ventilator-associated pneumonia (VAP) patients.
The company also has another mAb in phase 2 development targeting Pseudomonas aeruginosa (P. aeruginosa) liposaccharides serotype O11, which accounts for around 22% of all P.aeruginosa hospital acquired pneumonia cases globally.