SPA Agreement with FDA for Phase 3 PIVOT-PO Trial of Tebipenem HBr
Phase 3 PIVOT-PO trial is expected to begin with First Patient, First Visit in 4Q 2023
Sath Shukla Became President and CEO, Effective
Conference call and webcast at
"We are very pleased with the progress across our late-stage programs during the second quarter and in recent weeks,” said
Program Highlights and Upcoming Anticipated Milestones
Tebipenem HBr
- On
July 31, 2023 , Spero announced that it received written agreement from theU.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design and size of PIVOT-PO, a pivotal Phase 3 clinical trial of tebipenem HBr in patients with complicated urinary tract infection (cUTI), including acute pyelonephritis (AP). PIVOT-PO is a global, randomized, double-blind, Phase 3 clinical trial of oral tebipenem HBr vs. intravenous imipenem cilastatin, in hospitalized adult patients with cUTI/AP. The FDA has indicated that positive and persuasive results from PIVOT-PO, along with previously completed studies, could be sufficient to support approval of tebipenem HBr as a treatment for cUTI, including pyelonephritis, for a limited use indication. The trial is expected to begin with First Patient, First Visit in 4Q 2023. - Spero is entitled to receive a
$30 million development milestone payment, pursuant to its exclusive license agreement with GSK. Spero is also eligible to receive the following additional milestone/royalty payments under the terms of its license agreement with GSK, conditional upon achievement of certain progression of milestones: (1) up to an additional$120 million in development milestones as the Phase 3 clinical trial progresses; (2) up to$150 million in potential commercial milestones based on first commercial sales; (3) up to$225 million in potential sales-based milestones; and (4) low-single digit to low-double digit (if sales exceed$1 billion ) tiered royalties on net product sales of tebipenem HBr in all territories, exceptJapan and certain other Asian countries.
SPR720
- The Phase 2a clinical trial of SPR720, a potential novel first-line oral therapy for nontuberculous mycobacterial pulmonary disease (NTM-PD), continues to enroll participants at approximately 25 active sites, with topline data expected in the second half of 2024. The trial is expected to enroll up to 35 treatment-naïve or treatment-experienced participants with NTM-PD, who do not have treatment-refractory NTM-PD, due to Mycobacterium avium complex. The primary endpoint is evaluating changes in bacterial load in sputum samples from baseline to the end of the 56-day treatment period. Key secondary endpoints include assessments of clinical response, quality of life, pharmacokinetics, and safety and tolerability. For more information on the trial and its design, see ClinicalTrials.gov identifier NCT05496374.
SPR206
- Spero is preparing to advance SPR206, a novel, investigational, intravenously administered next generation polymyxin antibiotic being developed to treat MDR Gram-negative bacterial infections, into a Phase 2 trial in participants with hospital-acquired or ventilator-associated bacterial pneumonia. Spero expects to submit an Investigational New Drug (IND) application to the FDA to support this Phase 2 trial in the fourth quarter of 2023.
Management Update
- Satyavrat
"Sath" Shukla , Spero's prior Chief Financial Officer and Treasurer, became President and Chief Executive Officer (CEO) of the company, and a member of the Board of Directors, effectiveAugust 1, 2023 .Mr. Shukla succeeded Spero's prior CEO and President,Ankit Mahadevia , M.D., who became Chairman of the Board of Directors, effectiveAugust 1, 2023 . The prior Chairman of the Board,Milind Deshpande , Ph.D., is remaining on the Board of Directors as an independent director, and current Board member,Patrick Vink , MD., has been appointed Lead Director.
Second Quarter 2023 Financial Results
Spero reported a net loss for the second quarter ended
Total revenues for the second quarter of 2023 were
Research and development expenses for the second quarter of 2023 were
General and administrative expenses for the second quarter of 2023 of
As of
For further details on Spero’s financials, including results for the six-month period ended
Conference Call and Webcast
Spero will host a conference call and webcast today at
Tebipenem HBr Research Support
Select tebipenem HBr studies have been funded in part with federal funds from the
Government Agency Research Support
The views expressed in this press release are those of the authors and may not reflect the official policy or position of the
Select SPR206 studies are supported by the
Select SPR206 studies have been funded in whole or in part with Federal funds from the
About Spero Therapeutics
Spero Therapeutics is developing SPR720 as a novel oral therapy candidate for the treatment of a rare, orphan pulmonary disease caused by non-tuberculous mycobacterial infections.- Tebipenem HBr is an investigational drug in
the United States being developed for the treatment of cUTI, including pyelonephritis, caused by certain bacteria, in adult patients who have limited treatment options; tebipenem HBr is not FDA-approved. Spero Therapeutics also has an IV-administered next generation polymyxin product candidate, SPR206, developed from its potentiator platform, which is in development to treat MDR Gram-negative infections in the hospital setting.
For more information, visit www.sperotherapeutics.com
Forward Looking Statements
This press release may contain forward-looking statements. These statements include, but are not limited to, statements about the design, initiation, timing, progress and results of Spero's preclinical studies and clinical trials and its research and development programs, as well as the regulatory path forward for tebipenem HBr and potential FDA approval, the potential commercialization of tebipenem HBr and its future value, the potential receipt of milestone payments and royalties on future sales under the GSK license agreement, and Spero’s cash runway. 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 tebipenem HBr, SPR720 and SPR206 will advance through the 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 FDA or equivalent foreign regulatory agencies; whether the FDA will ultimately approve tebipenem HBr and, if so, the timing of any such approval; whether the FDA will require any additional clinical data or place labeling restrictions on the use of tebipenem HBr that would delay approval and/or reduce the commercial prospects of tebipenem HBr; whether a successful commercial launch can be achieved and market acceptance of tebipenem HBr can be established; whether results obtained in preclinical studies and clinical trials will be indicative of results obtained in future clinical trials; Spero's reliance on third parties to manufacture, develop, and commercialize its product candidates, if approved; Spero’s need for additional funding; the ability to commercialize Spero's product candidates, if approved; Spero's ability to retain key personnel; Spero’s ongoing leadership transitions; 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
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Condensed Consolidated Balance Sheet Data | ||||||
(in thousands) | ||||||
(Unaudited) | ||||||
2023 | 2022 | |||||
Cash, cash equivalents and marketable securities | $ | 77,690 | $ | 109,107 | ||
Other assets | 21,195 | 15,695 | ||||
Total assets | $ | 98,885 | $ | 124,802 | ||
Total liabilities | 44,103 | 48,868 | ||||
Total stockholder's equity | 54,782 | 75,934 | ||||
Total liabilities and stockholders' equity | $ | 98,885 | $ | 124,802 | ||
Condensed Consolidated Statements of Operations | ||||||||||||||||
(in thousands, except share and per share data) | ||||||||||||||||
(unaudited) | ||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Revenues: | ||||||||||||||||
Grant revenue | $ | 1,928 | $ | 1,097 | $ | 3,258 | $ | 2,919 | ||||||||
Collaboration revenue | 788 | 896 | 1,528 | $ | 1,143 | |||||||||||
Total revenues | 2,716 | 1,993 | 4,786 | 4,062 | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 9,510 | 8,173 | 18,489 | 25,144 | ||||||||||||
General and administrative | 6,096 | 8,051 | 13,413 | 23,356 | ||||||||||||
Restructuring | — | 11,849 | — | 11,849 | ||||||||||||
Total operating expenses | 15,606 | 28,073 | 31,902 | 60,349 | ||||||||||||
Loss from operations | (12,890 | ) | (26,080 | ) | (27,116 | ) | (56,287 | ) | ||||||||
Other income (expense) | 976 | (2,602 | ) | 1,936 | (5,224 | ) | ||||||||||
Net loss | $ | (11,914 | ) | $ | (28,682 | ) | $ | (25,180 | ) | $ | (61,511 | ) | ||||
Net loss attributable to common shareholders of | $ | (11,914 | ) | $ | (28,682 | ) | $ | (25,180 | ) | $ | (61,511 | ) | ||||
Net loss per share attributable to common shareholders per share, basic and diluted | $ | (0.23 | ) | $ | (0.87 | ) | $ | (0.48 | ) | $ | (1.88 | ) | ||||
Weighted average shares outstanding, basic and diluted: | 52,571,813 | 32,977,807 | 52,549,538 | 32,793,288 |
Source:
2023 GlobeNewswire, Inc., source