Top-line data for Phase 3 ADAPT-PO trial evaluating oral tebipenem HBr in complicated urinary tract infection expected in 3Q20
Conference call and live webcast at
“I am very pleased with our recent progress, as we are well positioned for the third quarter with top-line data from our Phase 3 ADAPT-PO clinical trial comparing oral tebipenem HBr to IV ertapenem expected before quarter end,” said Ankit Mahadevia, M.D., Chief Executive Officer of Spero Therapeutics. “We believe that tebipenem HBr, if approved, will have a significant benefit on the more than two million patients with avoidable hospitalizations for complicated urinary tract infections, and that the need for new, efficacious oral agents to keep patients out of the hospital has never been greater.”
Clinical Highlights and Upcoming Milestones
Spero remains committed to advancing its clinical programs while protecting the safety and well-being of patients, physicians and their staff. Spero is continuing to monitor and take steps to mitigate any effects of the COVID-19 pandemic on its business and clinical programs, while the
As a result of COVID-19, Spero now anticipates beginning a rolling submission of an NDA for tebipenem HBr for the treatment of cUTI to the FDA in the first quarter of 2021 and completion of the submission in the second quarter of 2021, pending positive data from its ongoing Phase 3 ADAPT-PO clinical trial and the FDA’s agreement with this submission approach. Spero expects to initiate its planned SPR206 Phase 1 BAL clinical trial in the first half of 2021.
Spero’s lead product candidate, tebipenem HBr, has the potential to be the first oral carbapenem antibiotic approved to treat MDR Gram-negative infections. Tebipenem HBr is currently being evaluated in the Phase 3 ADAPT-PO trial for the treatment of cUTI and acute pyelonephritis (AP). The trial completed enrollment of 1,372 patients in
ADAPT-PO compares an all oral regimen of tebipenem HBr with an existing standard of care intravenous (IV) antibiotic treatment, ertapenem, in patients with cUTI or AP, randomized 1:1 in each arm. The ADAPT-PO trial is supported by Phase 2 data in cUTI patients conducted by Spero’s partner
Spero anticipates the COVID-19 pandemic will impact data validation and analysis for the ongoing Phase 1 trials that are required for the NDA submission of tebipenem HBr in cUTI. Spero expects to begin a rolling submission of an NDA for tebipenem HBr for the treatment of cUTI to the FDA in the first quarter of 2021, pending positive ADAPT-PO Phase 3 clinical data and the FDA’s agreement on the approach, with a final submission planned for the second quarter of 2021 versus our previous guidance of the first quarter of 2021.
SPR720 is an orally administered antimicrobial agent being developed by Spero for the treatment of non-tuberculous mycobacterial (NTM) disease, a rare orphan disease, as well as other infections, including Mycobacterium tuberculosis. Spero announced positive top-line data from its Phase 1 clinical trial of SPR720 in healthy volunteers in
SPR206 is an IV-administered product candidate being developed as an innovative option to treat MDR Gram-negative bacterial infections. In January 2020, Spero reported positive preliminary Phase 1 clinical trial results for SPR206 in healthy volunteers. These results showed that SPR206 was well-tolerated at doses likely to be within a therapeutic range for MDR Gram-negative bacterial infections. In conjunction with Everest Medicines, and through its grant from the U.S. Department of Defense awarded in
Second Quarter 2020 Financial Results
Spero reported a net loss for the second quarter ended June 30, 2020 of $17.5 million or $0.85 per common share, compared to a net loss of
Total revenue for the second quarter of 2020 was
Research and development expenses for the second quarter of 2020 were $15.7 million, compared with
General and administrative expenses for the second quarter of 2020 of $4.5 million were higher than the
As of June 30, 2020, Spero had cash and cash equivalents of $71.4 million. Spero believes that its existing cash, cash equivalents and marketable securities, together with committed funding from the BARDA contract and other non-dilutive funding commitments, will be sufficient to fund its operating expenses and capital expenditure requirements into the first quarter of 2021.
Upcoming Investor and Clinical Presentations
- Corporate presentation at the Cantor Virtual Global Healthcare Conference 2020 being held
September 15– 17, 2020
- IDWeek 2020 Virtual Meeting being held
October 21– 25, 2020
- Corporate presentation at the
Stifel Healthcare Conferencebeing held November 17– 18, 2020w
Conference Call and Webcast
Spero will host a conference call and webcast today at 4:30 p.m. EDT. To access the call, please dial (877) 705-6003 (domestic) or (201) 493-6725 (international) and refer to conference ID 13706063. The conference call will also be webcast live and a link to the webcast can be accessed here and also on
Spero’s lead product candidate, tebipenem HBr (tebipenem pivoxil hydrobromide; formerly 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 an IV-administered next generation polymyxin product candidate, SPR206, developed from its potentiator platform that is being developed to treat MDR Gram-negative infections in the hospital setting.
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 Spero’s expectation that positive results from a single pivotal Phase 3 clinical trial of tebipenem HBr and ancillary supportive studies to be conducted in parallel with the Phase 3 trial will support the approval of tebipenem HBr; the design, initiation, timing, progress and results of Spero’s preclinical studies and clinical trials and its research and development programs, including the timing of Spero’s NDA submission with the FDA regarding tebipenem HBr, Spero’s IND submission with the FDA regarding SPR720, the commencement of Spero’s planned Phase 2a clinical trial of SPR720 and the commencement of Spero’s planned Phase 1 bronchoalveolar lavage (BAL) clinical trial assessing the penetration of SPR206 into the pulmonary compartment; management’s assessment of the results of such preclinical studies and clinical trials; the timing of clinical data, including final data from the Phase 3 clinical trial of tebipenem HBr, final data from the Phase 1 clinical trial of SPR720 and final data from the Phase 1 clinical trial of SPR206; the direct and indirect impact of the pandemic caused by an outbreak of a new strain of coronavirus on Spero’s business and operations, including manufacturing, research and development costs, clinical trials, regulatory processes and employee expenses; and Spero’s cash forecast and anticipated expenses, anticipated payments under Spero’s agreement with Everest Medicines, potential payments under Spero’s agreement with BARDA, 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 tebipenem HBr; 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 the FDA will accept a rolling NDA submission with respect to tebipenem HBr; whether Spero will satisfy all of the pre-conditions to receipt of the development milestone payment under its agreement with Everest Medicines; whether BARDA elects to exercise its second option under Spero’s agreement with BARDA; whether Spero’s cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; whether Spero’s clinical and preclinical development programs are delayed or disrupted due to the coronavirus; and other factors discussed in the “Risk Factors” set forth in filings that Spero periodically makes with the U.S. Securities and 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
|Condensed Consolidated Statements of Operations
|(Unaudited, amounts in thousands, except share and per share data)|
|Three Months Ended
||Six Months Ended
|Research and development||15,656||12,026||36,092||21,552|
|General and administrative||4,547||3,782||8,633||7,670|
|Total operating expenses||20,203||15,808||44,725||29,222|
|Loss from operations||(18,476||)||(13,652||)||(41,297||)||(19,348||)|
|Other income (expense)||975||502||538||1,126|
|Net loss attributable to common shareholders of
|Net loss per share attributable to common shareholders per share, basic and diluted||$||(0.85||)||$||(0.74||)||$||(2.06||)||$||(1.04||)|
|Weighted average shares outstanding, basic and diluted:||20,633,402||17,667,620||20,095,415||17,445,600|
|Condensed Consolidated Balance Sheet Data|
|(Unaudited, amounts in Thousands)|
|Cash, cash equivalents and marketable securities||$||71,360||$||82,045|
|Total stockholder's equity||73,714||74,574|
|Total liabilities and stockholders' equity||$||97,545||$||106,103|
Source: Spero Therapeutics, Inc.