Spero Gets Fast Track Designation For SPR994, Shares Improve
Zacks Investment Research | Apr 01, 2019 04:00AM ET
Shares of Spero Therapeutics, Inc. (NASDAQ:SPRO) increased about 6% after the company announced that the FDA granted Fast Track designation to SPR994, the company’s lead product candidate designed to be the first oral carbapenem antibiotic, for the treatment of complicated urinary tract infections (cUTI) and acute pyelonephritis.
Shares of the company have decreased 9.8% in the past year compared with the industry ’s decline of 4.7%.
The FDA grants Fast Track designation to help the development and a faster review of drugs, which treat serious and unmet medical conditions. With this designation, the drug is expected to be granted priority review once the company files a new drug application (“NDA”).
The company has planned a phase III study, whereinoral SPR994 will be compared with an existing standard of care intravenous (IV) antibiotic, ertapenem in about 1,200 patients randomized 1:1 in each arm. The primary endpoint of the study will be the combined clinical and microbiological response at the test of cure, with a 10% non-inferiority margin versus IV ertapenem. The study will incorporate a lead-in cohort of 70 patients, with an intensive pharmacokinetics assessment to confirm the dose and exposure in the cUTI patient population. Spero expects to receive pharmacokinetic data from the lead-in cohort in the second half of 2019.
Recently, the FDA granted approval for the label expansion of Allergan plc’s (NYSE:AGN) anti-infective drug, Avycaz (ceftazidime and avibactam) in pediatric patients as monotherapy for cUTI, and in combination with metronidazole for complicated intra-abdominal infections (cIAI). This is the first drug to receive approval for pediatric patients with cUTI or cIAI in more than a decade. Avycaz is jointly marketed by Allergan and Pfizer (NYSE:PFE) .
Zacks Rank & Stock to Consider
Spero is currently a Zacks Rank #3 (Hold) stock.
A better-ranked stock worth considering is Johnson & Johnson (NYSE:JNJ) , carrying a Zacks Rank #2 (Buy). You can see .
Johnson & Johnson’s earnings per share estimates have increased from $9.20 to $9.21 for 2020 in the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average of 1.61%.
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