Armata's AP-PA02 Gets IND Clearance by FDA to Initiate Study

Armata Pharmaceuticals, Inc. ARMP announced that the FDA has cleared its investigational new drug (IND) application to initiate a phase Ib/IIa study of its lead therapeutic candidate, AP-PA02, in Pseudomonas aeruginosa infections. The company is developing PA02, a phage cocktail for the treatment of Pseudomonas aeruginosa infections in cystic fibrosis patients.

Shares of the company have gained 7.7% year to date against the industry’s decline of 0.2%.

The SWARM-P.a. study will be a phase Ib/IIa, multi-center, double-blind, randomized, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study to evaluate the safety and tolerability of inhaled AP-PA02 in subjects with cystic fibrosis and chronic pulmonary Pseudomonas aeruginosa infection. Barring worsening COVID-19 conditions, Armata expects to initiate the SAD cohort by the end of 2020.

Per the company, the study will be the first FDA-cleared, controlled study to evaluate a multiple phage-based mixture as a therapeutic candidate in cystic fibrosis patients. This study will evaluate the potential of phage to combat multi-drug resistant infections and aims to develop alternatives to antibiotics. The study will initially evaluate AP-PA02 in combination with standard antibiotics but the company ultimately aims to replace antibiotics withthe product candidate as front-line therapy.

Armata is also developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, Staphylococcus aureus and other pathogens. 

Zacks Rank & Stocks to Consider

Armata currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the healthcare sector include Emergent Biosolutions Inc. EBS, Castle Biosciences, Inc. CSTL and AVEO Pharmaceuticals Inc. AVEO. While Emergent and Castle Biosciences sport a Zacks Rank #1 (Strong Buy), AVEO carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Emergent’s earnings estimates have increased from $4.03 to $6.61 for 2020 and from $5.07 to $8.42 for 2021 over the past 90 days. Shares of the company have increased 84.5% year to date.

Castle Biosciences’ loss per share estimates have narrowed from 51 cents to 11 cents for 2020 over the past 90 days. Shares of the company have increased 47.8% year to date.

AVEO’s loss per share estimates have narrowed from $1.58 to $1.25 for 2020 and from $1.56 to $1.22 for 2021 over the past 60 days. Shares of the company have decreased 2.5% year to date.


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