-Spero and Meiji Seika Pharma Co., LTD. announce an exclusive license partnership for SPR994
-FDA grants SPR994 Qualified Infectious Disease Product (QIDP) status for complicated urinary tract infections (cUTI), diabetic foot infections (DFI) and community acquired bacterial pneumonia (CABP)
CAMBRIDGE, Mass., Oct. 10, 2017 (GLOBE NEWSWIRE) — Spero Therapeutics, Inc., a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multi-drug resistant bacterial infections, today announced that it has entered into an exclusive license agreement to support development and commercialization of SPR994, with potential to be the first broad-spectrum oral carbapenem for use in adults.
“We are pleased to have licensed SPR994 and have achieved the significant milestone of receiving QIDP status for the candidate. There is a significant unmet need for a new oral treatment for the growing emergence of drug resistant Gram-negative infections in the hospital and community settings. SPR994 has the potential to help patients transition out of the hospital or to keep them out of the hospital altogether,” said Ankit Mahadevia, MD, Chief Executive Officer, Spero Therapeutics.
SPR994 is designed to be a broad-spectrum oral carbapenem for use in adults to treat MDR Gram-negative infections, including those resistant to fluoroquinolones. Fluoroquinolones are the most widely used oral class of antibiotics to treat urinary tract infections, yet resistance rates to fluoroquinolones have more than doubled in the hospital and community settings. This has led to a growing number of hospitalizations and extended lengths of stay in the hospital because of the lack of effective oral antibiotics to treat these MDR Gram-negative infections. Carbapenems are considered the standard of care for many serious MDR Gram-negative bacterial infections, but to date they have only been available as IV-administered formulations. We believe the orally available SPR994 has the potential to address this unmet need of treating MDR Gram-negative infections in the community setting to help avoid hospitalization and in the hospital setting to help accelerate hospital discharge.
SPR994 was licensed from Meiji Seika Pharma Co., Ltd. (Meiji) earlier this year. Meiji currently markets under the trade name Orapenem®, the oral formulation of SPR994. Orapenem was approved for sale in Japan in 2009 and is marketed in certain Asian countries by Meiji. As a part of the development of Orapenem, approximately 1,200 adult and pediatric subjects were administered Orapenem in clinical and pharmacologic studies. As a result of this agreement, Spero will receive global rights to data and know-how that will be used to develop and commercialize SPR994, except in Japan and certain Asian countries, where Meiji will retain rights.
In addition, Spero has received QIDP designation from the U.S. Food & Drug Administration (FDA) for SPR994 for the treatment of cUTI, DFI and CABP. QIDP designation, provided under the Generating Antibiotic Incentives Now (GAIN) Act, offers certain incentives for the development of new antibacterial or antifungal drugs, including eligibility for “fast track” designation, priority review for regulatory approval by the FDA and, if SPR994 is ultimately approved by the FDA, eligibility for an additional five years of marketing exclusivity. The potential for fast track designation provides additional opportunities for interaction with the FDA’s review team and may expedite the development and review process for drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical need.
Spero Therapeutics is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multi-drug resistant (MDR) bacterial infections.
Spero is advancing SPR994, which is designed to be the first broad-spectrum oral antibiotic for use in adults to treat MDR Gram-negative infections.
Spero is also advancing its Potentiator Platform, which 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. SPR741, Spero’s lead potentiator product candidate, is a clinical-stage, IV-administered agent that has been observed in in vitro studies to potentiate over two dozen existing antibiotics by expanding their activity against Gram-negative pathogens. SPR206, Spero’s preclinical potentiator product candidate, is also designed to have antibiotic activity as a single agent against certain MDR and extremely drug resistant (XDR) bacterial strains.
Spero is also developing SPR720, its novel oral therapy product candidate designed for the treatment of pulmonary non-tuberculous mycobacterial (NTM) infections.
For more information, please visit https://sperotherapeutics.com
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