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SPRO

Spero Therapeutics

$9.04

-0.29 (-3.11%)

08:28
01/13/20
01/13
08:28
01/13/20
08:28

Spero Therapeutics announces preliminary findings from Phase 1 trial of SPR206

Spero Therapeutics announced preliminary findings from its Phase 1 first-in-humans clinical trial of SPR206, an IV-administered product candidate being developed by Spero as an innovative option to treat MDR Gram-negative bacterial infections. Analysis of preliminary, blinded data from the Phase 1 double-blind, placebo-controlled single ascending dose and multiple ascending dose clinical trial in healthy adult volunteers suggests that SPR206 is well-tolerated at doses that are likely to be within a therapeutic range for target MDR Gram-negative bacterial infections and has a safety profile that Spero believes supports the further development of SPR206. The decision to continue development of SPR206 is also supported by data from nonclinical studies in which SPR206 demonstrated activity as a single agent against MDR and extensively drug resistant bacterial strains, including isolates of Pseudomonas aeruginosa, Acinetobacter baumannii and carbapenem-resistant Enterobacteriaceae, in both in vitro and in vivo models of infection.The Phase 1 clinical trial of SPR206 evaluated the safety, tolerability and pharmacokinetics of intravenously administered SPR206 at single doses ranging from 10 mg to 400 mg in seven SAD cohorts and repeat total daily doses ranging from 75 mg to 450 mg for seven consecutive days and 300 mg for 14 consecutive days across five MAD cohorts. A total of 96 healthy volunteers were randomized to receive SPR206 or placebo. All reported adverse events were mild to moderate and there were no reported severe or serious adverse events. No evidence of nephrotoxicity was observed and there were no subjects with clinically significant changes in laboratory tests during the study. Although the data remain blinded, an analysis of preliminary data indicates that SPR206 was well-tolerated at doses up to 100 mg administered three-times a day, a total of 300 mg daily, for 14 consecutive days. Preliminary analyses of pharmacokinetic data across the cohorts indicates dose linearity and dose proportionality as well as mean plasma drug exposures of SPR206 that are concordant with preclinical models predictive for clinical efficacy against target Gram-negative pathogens. Spero expects to receive a development milestone payment from its partner Everest Medicines upon delivery of the SPR206-101 SAD/MAD clinical study report as specified under the regional collaboration launched in 2019 and expects to present final data from the Phase 1 clinical trial in the first half of 2020. In conjunction with Everest Medicines, and through its grant from the U.S. Department of Defense awarded in July 2019, Spero plans to conduct a Phase 1 bronchoalveolar lavage clinical trial assessing the penetration of SPR206 into the pulmonary compartment in the second half of 2020 as well as initiate a renal impairment study of SPR206.

SPRO Spero Therapeutics
$9.04

-0.29 (-3.11%)

09/09/19
JANY
09/09/19
INITIATION
Target $27
JANY
Buy
Spero Therapeutics initiated with a Buy at Janney Montgomery Scott
Janney Montgomery Scott initiated Spero Therapeutics with a Buy and $27 price target.
10/02/19
OPCO
10/02/19
NO CHANGE
Target $20
OPCO
Outperform
Spero Therapeutics price target lowered to $20 from $30 at Oppenheimer
Oppenheimer analyst Kevin DeGeeter lowered his price target for Spero Therapeutics to $20 from $30 based on removing SPR741 and SPR206 from his revenue model along with more modest commercial assumptions for SPR994. The analyst has an Outperform rating on the shares given potential for SPR994 to generate positive Phase III results and healthy commercial launch based on use as first-in-class oral carbapenem for nonhospital settings.
10/03/19
JANY
10/03/19
NO CHANGE
Target $31
JANY
Buy
Spero price target raised to $31 from $27 at Janney Montgomery Scott
Janney Montgomery Scott analyst Esther Hong raised her fair value estimate on shares of Spero Therapeutics to $31 from $27, citing her view that the company's Phase 3 study of SPR994 has been "meaningfully de-risked" by the lead-in pharmacokinetic data. Hong maintains a Buy rating on the stock.
11/05/19
HCWC
11/05/19
NO CHANGE
Target $35
HCWC
Buy
Spero Therapeutics price target raised to $35 from $28 at H.C. Wainwright
H.C. Wainwright analyst Raghuram Selvaraju raised his price target for Spero Therapeutics to $35 from $28 after the company announced that an independent review committee evaluated pharmacokinetic data following enrollment of the first 70 patients and recommended that Spero continue the trial using the protocoldefined dose without modification. As a result, the analyst increased his SPR994 probability of launch to 85% from the previous 70%. He keeps a Buy rating on Spero Therapeutics.

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