Presentations will highlight the potential for oral SPR994 to change the treatment landscape in cUTI and the opportunity for oral SPR720 in NTM
CAMBRIDGE, Mass., Nov. 26, 2019 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multi-drug resistant (MDR) bacterial infections and rare diseases, today announced that it will host a key opinion leader breakfast symposium on the unmet need, treatment landscape and potential for oral SPR994 as a new therapeutic option in complicated urinary tract infections (cUTI), as well as the opportunity for oral SPR720 in non-tuberculous mycobacterial (NTM) infections. The event will be held on Thursday, December 5, 2019, from 8:30 a.m. – 10:30 a.m. ET in New York.
As part of the event, Yoav Golan, MD, MS, FIDSA, Attending Physician and Associate Professor of Medicine at the Tufts University School of Medicine, will present an overview of the burden of disease in cUTI and the potential for oral SPR994 to change the treatment landscape. If approved, SPR994 has the potential to be the first oral carbapenem antibiotic for use in adults to treat cUTI. A pivotal Phase 3 clinical trial of SPR994 for the treatment of cUTI entitled ADAPT-PO continues to enroll patients, and Spero expects to report top-line data from the Phase 3 clinical trial in the third quarter of 2020.
The Company will also present an overview of the progress in the SPR720 program. SPR720 is an orally administered antimicrobial agent being developed for the treatment of a rare, orphan disease, non-tuberculous mycobacterial (NTM) infections and other infections, including Mycobacterium tuberculosis. SPR720 is currently being evaluated in a double-blind, placebo-controlled Phase 1 clinical trial to assess the safety, tolerability and pharmacokinetics of SPR720 in healthy volunteers. Spero expects to report top-line data from the Phase 1 clinical trial by year-end 2019.
A live webcast of the event may be accessed through Spero Therapeutics’ website (www.sperotherapeutics.com) on the “Events and Presentations” page under the “Investors and Media” tab. A replay of the event will be archived on the website for 90 days following the conclusion of the event.
About Spero Therapeutics, Inc.
Spero Therapeutics, Inc. is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multidrug-resistant (MDR) bacterial infections and rare diseases.
Spero’s lead product candidate, SPR994, is designed to be the first oral carbapenem-class antibiotic for use in adults to treat MDR Gram-negative infections.
Spero is also advancing SPR720, its novel oral therapy product candidate designed for the treatment of rare, orphan disease caused by pulmonary non-tuberculous mycobacterial (NTM) infections.
Spero also has a platform technology known as its Potentiator Platform that it believes will enable it to develop drugs that will expand the spectrum and potency of existing antibiotics, including formerly inactive antibiotics, against Gram-negative bacteria. Spero’s lead product candidates generated from its Potentiator Platform are two IV-administered agents, SPR206 and SPR741, designed to treat MDR Gram-negative infections in the hospital setting.
Forward Looking Statements
This press release may contain forward-looking statements. These statements include, but are not limited to, statements about Spero’s expectation that positive results from a single pivotal Phase 3 clinical trial of SPR994 and ancillary supportive studies to be conducted in parallel with the Phase 3 trial will support the approval of SPR994; the initiation, timing, progress and results of Spero’s preclinical studies and clinical trials and its research and development programs; statements regarding management’s assessment of the results of such preclinical studies and clinical trials; the timing of clinical data, including the availability of pharmacokinetic data from the lead-in cohort in the Phase 3 clinical trial of SPR994 and top-line data from the Phase 1 clinical trial of SPR720 and the Phase 1 clinical trial of SPR206; and Spero’s cash forecast and anticipated expenses, the sufficiency of its cash resources and the availability of additional non-dilutive funding from governmental agencies beyond any initially funded awards. In some cases, forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intent,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether the FDA will accept a single pivotal study for approval of SPR994; whether results obtained in preclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether Spero’s product candidates will advance through the preclinical development and clinical trial process on a timely basis, or at all, taking into account the effects of possible regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, clinical trial design and clinical outcomes; whether the results of such trials will warrant submission for approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; whether Spero’s cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; and other factors discussed in the “Risk Factors” set forth in filings that Spero periodically makes with the U.S. Securities Exchange Commission. The forward-looking statements included in this press release represent Spero’s views as of the date of this press release. Spero anticipates that subsequent events and developments will cause its views to change. However, while Spero may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Spero’s views as of any date subsequent to the date of this press release.
Spero Investor and Media Contact:
Senior Director, Investor Relations