Benzinga | Jul 19, 2021 08:33AM EDT

Aridis Pharmaceuticals Announces Exclusive License Of Suvratoxumab Phase 3-Ready Monoclonal Antibody From AstraZeneca; Highlights Uo To $30M Funding From EU Commission For Phase 3 Trial

Aridis Pharmaceuticals, Inc. (NASDAQ:ARDS) today announced that it has entered into an exclusive, worldwide licensing agreement with AstraZeneca (NASDAQ:AZN) to in-license the late stage monoclonal antibody candidate, suvratoxumab.

The highlights of the agreement are:

* Phase 3-ready candidate. Suvratoxumab monoclonal antibody (mAb) for prevention of pneumonia has been licensed from AstraZeneca. Suvratoxumab extends Aridis' pneumonia franchise by complementing the existing AR-301 Phase 3 pneumonia treatment program.

* Lancet ID publication. Phase 2 data involving n=196 patients recently published in The Lancet Infectious Diseases journal showed safety and a statistically significant (47%) relative reduction of pneumonia in S. aureus colonized, mechanically ventilated patients less than 65 years old, with corresponding reduction in the number of days needed in the ICU and hospital.i

* Up to (euro)25 million Euros funding (approximately $30 million). EU Commission's Innovative Medicines Initiatives (IMI) funding for suvratoxumab Phase 3 clinical trial

* AstraZeneca's equity stake in Aridis. AstraZeneca becomes a shareholder of Aridis through the issuance of common stock and has right of first negotiation for future licensing of suvratoxumab.

Monoclonal DevelopmentNext Targeting Disease Antibody Status Milestone

S. aureus colonized Staphylococcus Phase 3 suvratoxumab or patients at high riskPhase 2 aureus alpha launch 'AR-320' of developing completed toxin 4Q-2021 pneumonia

Deal Highlights

* Aridis acquires global exclusive rights for development and commercialization of suvratoxumab for all indications

* AstraZeneca retains rights of first negotiation for future licensing

* Aridis will make an upfront payment to AstraZeneca of $11m in cash and Aridis common stock. AstraZeneca will also receive up to a further $115m on achievement of certain development and sales-related milestones, in addition to tiered royalties on net sales

* Up to ?25 million Euros (approximately $30m) from EU Commission's Innovative Medicines Initiative (IMI) COMBACTE clinical trial consortium for the Phase 3 trial for suvratoxumab

Development Overview: Suvratoxumab Phase 3 Clinical Study

Suvratoxumab and AR-301 are complementary products. Suvratoxumab's focus on preventive treatment of S. aureus pneumonia complements Aridis' AR-301 Phase 3 mAb program which is being developed as a therapeutic treatment of S. aureus pneumonia.

A multinational, randomized, double blinded, placebo controlled Phase 2 study (n=196 patients) showed that mechanically ventilated ICU patients colonized with S. aureus who are treated with suvratoxumab saw a relative risk reduction of pneumonia by 32% in the overall intend to treat (ITT) study population, and by 47% in the under 65 year old population, which is the target population in the planned Phase 3 study. The relative risk reduction in the target population reached statistical significance, and was also associated with a substantial reduction in the duration of care needed in the ICU and hospital.i [see https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30995-6/fulltext]

Aridis believes that suvratoxumab (product code name 'AR-320') will be first-line treatment, first to market, first-in-class pre-emptive treatment of S. aureus colonized patients. The same first-line, first to market and first-in-class strategy applies to the acute treatment with the monoclonal antibody AR-301 which the Company believes makes Aridis a globally dominant leader in this space.