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Spero Therapeutics Receives QIDP Designation from the U.S. FDA for the Development of SPR206
CAMBRIDGE, Mass., Oct. 11, 2018 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multidrug-resistant bacterial infections, announced today that SPR206, a product candidate within Spero’s Potentiator Platform, has been granted Qualified Infectious Disease Product (QIDP) designation by the U.S. Food and Drug Administration for the treatment of complicated urinary tract infections (cUTI) and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).
“We are pleased that the FDA recognized the potential of SPR206’s novel approach to treat multidrug-resistant Gram-negative infections and provided it with QIDP status,” said Ankit Mahadevia, M.D., CEO of Spero Therapeutics. “We look forward to advancing SPR206 into a Phase 1 clinical trial in 2019.”
SPR206 is designed as a single agent to treat multidrug resistant (MDR) and extensively drug-resistant (XDR) bacterial strains, including carbapenem-resistant Pseudomonas aeruginosa, Acinetobacter baumannii, and Enterobacteriaceae, for which there is a significant unmet medical need. Based on promising results from preclinical toxicology studies for SPR206, Spero plans to initiate a Phase 1 clinical trial to assess the safety, tolerability and pharmacokinetics of SPR206 in 2019.
The QIDP designation was created by the Generating Antibiotic Incentives Now (GAIN) Act and creates incentives for the development of certain antibiotics that treat serious or life-threatening infections. The primary incentives are an additional five-year extension of Hatch-Waxman Act exclusivity, as well as the opportunity for a priority review of the marketing application for SPR206 once submitted and to request Fast Track designation for SPR206.
SPR206 Research Support
This project has been funded in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201500014C.
About the Spero Potentiator Platform – SPR206 and SPR741
The Potentiator Platform molecules are designed to treat Gram-negative bacterial infections through the molecules’ interactions with the bacteria’s outer cell membrane as a monotherapy or by co-administering our Potentiator Platform molecules with existing antibiotics, potentially making the existing antibiotics more effective by clearing a path for them to enter and kill the bacteria. Spero has two Potentiator Platform product candidates – SPR741, a combination IV-administered agent that has been evaluated in vitro in which we observed expansion of the spectrum and increase in potency of a co-administered antibiotic; and SPR206, a direct acting IV-administered agent that has shown in vitro activity alone. Both have demonstrated potency in vitro against Gram-negative bacteria, including organisms identified by the Centers for Disease Control and Prevention, or the CDC, and the World Health Organization, or the WHO, as urgent and serious threats to human health. SPR206 is designed to also have antibiotic activity as a single agent against MDR and extremely drug resistant, or XDR, bacterial strains, including variants isolated in Pseudomonas aeruginosa, Acinetobacter baumannii and carbapenem-resistant Enterobacteriaceae. Spero plans to initiate a Phase 1 clinical trial for SPR206 in 2019. In preclinical studies, SPR741 was able to potentiate over two dozen existing antibiotics by expanding their activity against Gram-negative pathogens and has been evaluated in two Phase 1 clinical trials in healthy volunteers supporting its tolerability. The Company expects that data from a Phase 1 clinical trial of SPR206, together with the data from our completed Phase 1b clinical trial of SPR741, will enable the selection of a lead candidate from the Potentiator Platform to move forward into late stage development. Spero believes that its current intellectual property portfolio and pending patent applications will provide global protection, including in the United States and Europe, through 2038 and 2039 for SPR741 and SPR206, respectively.
Spero is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multidrug-resistant (MDR) bacterial infections.
Spero’s lead product candidate, SPR994, is designed to be the first broad-spectrum oral carbapenem-class antibiotic for use in adults to treat MDR Gram-negative 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 intravenous, or IV,-administered agents, SPR741 and SPR206, designed to treat MDR Gram-negative infections in the hospital setting.
Spero is also advancing SPR720, its novel oral therapy product candidate designed for the treatment of pulmonary non-tuberculous mycobacterial infection.
For more information, visit https://sperotherapeutics.com.
This press release may contain forward-looking statements. These statements include, but are not limited to, statements about the initiation, timing, progress and results of Spero’s preclinical studies and clinical trials and its research and development programs, including statements regarding management’s assessment of the results of such preclinical studies and clinical trials, the timing of clinical data, 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 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; 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 we periodically make 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.
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