AstraZeneca offloads pneumonia prevention drug to Aridis Pharmaceuticals through worldwide license agreement, which will net Big Pharma $ 11 million in cash and another $ 115 million down the line.
Usually these deals go the other way, with a large company taking over the rights to a smaller biotech candidate, but in this case the UK drugmaker is the one passing on an asset.
The monoclonal antibody candidate, called suvratoxumab, is ready for phase 3 testing after pre-mid-term data revealed that treatment resulted in a 47% reduction in pneumonia in patients under 65 who were on ventilators, Aridis said in a press release. Patients have also seen a reduction in the number of days needed in the ICU or hospital.
Data published in The Lancet in April, however, suggests that the the trial failed to reduce the incidence of pneumonia caused by Staphylococcus aureus infection, which is one of the main causes of ventilation-associated pneumonia. The analysis included the entire trial population of 767 patients. Aridis focused on a subset of 196 patients under the age of 65 upon discharge.
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AstraZeneca will remain involved in suvratoxumab, as the new agreement gives the company a stake in Aridis and allows the first negotiations on future licenses. The upfront payment will add an additional $ 115 million for AstraZeneca if certain development and sales milestones are met.
Aridis plans to launch a phase 3 study in the fourth quarter. Biotechnology received 25 million euros for the study of the Initiative for Innovative Medicines of the European Commission.
“We are delighted to have been selected as the AstraZeneca licensee,” said Aridis CEO Vu Truong, Ph.D. “The strong data from the Phase 2 trial gives us an advantage to define the patient population, the primary endpoint and the design of the phase 3 clinical study to support a clear path to the confirmatory phase 3 trial. ”
Aridis, which is focused on developing anti-infective treatments that can be used in combination with antibiotics, believes that suvratoxumab may address an unmet medical need in a high-risk population.
The drug looks a bit like what we see with COVID vaccines and mAbs: with pneumonia there are vaccines, such as those from Pfizer and Merck, for many different strains of bacterial pneumonia, but AZ also increases the arsenal with this antibody to help reduce the risk of the disease when it has already struck.
“Suvratoxumab has the potential to transform the management of lung infections in ventilated patients,” said Mark Esser, vice president of R&D in microbial sciences and biopharmaceuticals at AstraZeneca. “We are delighted to enter into this licensing agreement with Aridis which we believe is well positioned to advance suvratoxumab. “
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The therapy, although under the wing of AstraZeneca, has achieved expedited designation in Phase 2 clinical trials in the United States were supported by The National Institute of Allergy and Infectious Diseases of the National Institutes of Health as part of their efforts to fight antibiotic resistance. The US research agency said that suvratoxumab is not an antibiotic but can be given with common treatments.