Aridis Pharmaceuticals Inc (NASDAQ:ARDS) announced Friday that it expects to share a readout of top-line data during the third quarter from its flagship AR-105 treatment which protects against a variety of Pseudomonas aeruginosa strains, or gram-negative, rod-shaped bacterium that cause deadly disease.
The company said that an “important fourth quarter clinical highlight” was the enrollment progress in a global Phase 2 study for AR-105 as a treatment for ventilator-associated pneumonia (VAP) caused by Pseudomonas aeruginosa. While critically ill patients experience a life-threatening illness, they commonly contract ventilator-associated pneumonia.
The Phase 2 study expanded from 108 patients to at least 154 patients and is within one month of completing patient enrollment. Aridis expects to announce the readout of top-line data during the third quarter.
"The fourth quarter was an important development period for several of our core programs on clinical and corporate fronts," Aridis Pharmaceuticals CEO Vu Truong said in a statement. "A major priority during the period was preparing for the upcoming launch of a pivotal Phase 3 study of AR-301 which is clearly a key milestone. Moreover, I'm equally pleased with the rapid progression of our AR-105 clinical trial."
Consensus was received from the Food & Drug Administration and European Medicines Agency (EMA) on the company’s initiation of a Phase 3 pivotal study of AR-301 targeting gram-positive Staphylococcus aureus, a round-shaped bacterium which poses a lethal challenge to critically ill VAP patients.
“Reached concurrence from US FDA and EMA for a globally harmonized Phase 3 clinical study design for AR-301 and acceptance of clinical cure as the primary endpoint,’ said the company.
This study is initiated, and interim data is expected in the first quarter of 2020 and top-line data expected in late 2020.
The company has $24 million in cash and cash equivalents as of December 31, 2018, to fund operations into the first quarter of 2020.
Total revenues for 2018 were $2.8 million, an increase of $1.9 million over 2017. Grant revenue increased by approximately $1.5 million due primarily to the achievement of various milestones under the company’s agreement with the CF Foundation.
The company narrowed its net loss for the year ended December 31, 2018, to $23.5 million, or $7.46 per share, compared to a net loss of $27.5 million, or $164.98 per share for the year ended December 31, 2017.
San Jose, California-based Aridis Pharmaceuticals discovers and develops anti-infectives to be used as add-on treatments to standard-of-care antibiotics. It was founded in 2003.
Contact Uttara Choudhury at [email protected]