Spero Therapeutics, Inc. SPRO announced preliminary results from a phase I first-in-human study, which evaluated its oral antimicrobial agent SPR720 for the treatment of nontuberculous mycobacterial (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 that supports its further development for the above-mentioned indication.
Spero plans to request a meeting with the FDA authorities in the first half of 2020 and submit an investigational new drug (IND) application to initiate a phase IIa study on SPR720 in the second half of next year.
Per the company, no oral antibiotic has been approved so far by the FDA to treat NTM pulmonary disease. The preliminary safety, tolerability and pharmacokinetic data on SPR720 indicates that the candidate has the potential to significantly change the treatment paradigm of this chronic, debilitating disease for which very limited treatment options are currently available.
The phase I study evaluated the safety, tolerability and pharmacokinetic of SPR720 administered orally at single doses ranging from 100 mg to 2000 mg and repeat total daily doses ranging from 500 mg to 1500 mg for up to seven to 14 days. Notably, no serious adverse side effects were reported.
Shares of Spero have surged 84.9% so far this year, outperforming the
industry’s increase of 5.3%.
We remind investors that Spero is a clinical-stage biopharmaceutical company engaged in developing and commercializing novel treatments for multidrug-resistant (MDR) bacterial infections and rare diseases.
The company’s lead product candidate SPR994 is designed to be the first oral carbapenem antibiotic, for the treatment of complicated urinary tract infections (cUTI) and acute pyelonephritis.
A pivotal phase III study on SPR994 continues to enroll patients for treating cUTI. Spero plans to report top-line data from this study in the third quarter of 2020.
Zacks Rank & Stocks to Consider
Spero currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Anika Therapeutics Inc.
ANIK, Vertex Pharmaceuticals Inc. ( VRTX Quick Quote VRTX - Free Report) and Guardant Health, Inc. GH, all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here .
Anika’s earnings estimates have moved 16% north for 2019 and 17.4% for 2020 over the past 60 days. The stock has soared 69.8% so far this year.
Vertex’s earnings estimates have been revised 5% upward for 2019 and 10.6% for 2020 over the past 60 days. The stock has surged 35.1% year to date.
Guardant Health’s loss per share estimates have narrowed 30.7% for 2019 and 8.5% for 2020 over the past 60 days. The stock has skyrocketed 99.4% so far this year.
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