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Spero's (SPRO) IND Accepted by FDA for Pulmonary Disease Drug

Zacks Equity Research
·3 mins read

Spero Therapeutics, Inc. SPRO) announced that the FDA accepted its investigational new drug application (IND) for oral antimicrobial agent SPR720, in development for the treatment of nontuberculous mycobacterial (NTM) pulmonary disease. 

Spero now plans to initiate a phase IIastudyonSPR720 in patients with NTM pulmonary disease by the end of the year. The study will enroll about 90 treatment-inexperienced patients with NTM pulmonary disease due to Mycobacterium avium complex (MAC). MAC is a group of bacteria related to tuberculosis. Patients will be randomized to receive either 500mg or 1,000mg of oral SPR720, placebo or standard of care medicines like macrolide and ethambutol, plus have the option of adding a rifamycin over 28 days of treatment. 

Shares of Spero have gained 13% so far this year, outperforming the industry’s growth of 2.7%.

In December 2019, the companyannounced preliminary results from a phase I first-in-human study, which evaluated SPR720 NTM pulmonary disease. Blinded data from the early-stage placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) study showed that SPR720 was generally well-tolerated in healthy volunteers with a pharmacokinetic profile.

Spero’s lead pipeline candidate is SPR994, which is designed to be the first oral carbapenem antibiotic for the treatment of complicated urinary tract infections (cUTI) and acute pyelonephritis.

Zacks Rank & Stocks to Consider

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

Some better-ranked stocks in the healthcare sector include Emergent Biosolutions Inc. EBS, Horizon Therapeutics Public Limited Company HZNP and Alimera Sciences Inc. ALIM. While Emergent and Horizon Therapeutics sport a Zacks Rank #1 (Strong Buy), Alimera 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 $3.45 to $6.32 for 2020 and from $4.31 to $7.01 for 2021 over the past 60 days.

Horizon Therapeutics’ earnings estimates have increased from $1.78 to $2.86 for 2020 and from $2.74 to $4.29 for 2021 over the past 60 days.

Alimera’s loss per share estimates have narrowed from $2.33 to $1.31 for 2020 and from 63 cents to 52 cents for 2021 over the past 60 days.

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