SPERO THERAPEUTICS, INC. Special Protocol Assessment Agreement with FDA for Phase 3 PIVOT-PO trial of tebipenem HBr; Trial expected to begin with First Patient, First Visit in 4Q 2023
Conference call and webcast at
"Having made substantial progress across our late-stage programs throughout 2023, we look forward to important milestones before year-end,” said
Program Highlights and Upcoming Anticipated Milestones
Tebipenem HBr
- Spero received written agreement from the
U.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, pivotal Phase 3 clinical trial of oral tebipenem HBr vs. intravenous (IV) imipenem cilastatin, in hospitalized adult patients with cUTI/AP. Patients will be randomized 1:1 to receive tebipenem HBr (600 mg) orally every six hours, or imipenem cilastatin (500 mg) IV every six hours, for a total of seven to ten days. The primary efficacy endpoint will be overall response (composite of clinical cure plus microbiological eradication) at the test-of-cure visit. The primary analysis for the trial will be an assessment of non-inferiority (NI) in the microbiological intention-to-treat population, based on a 10% NI margin. The trial is designed to enroll approximately 2,648 patients, with randomization stratified by age, baseline diagnosis (cUTI or AP), and the presence or absence of urinary tract instrumentation. For further details on the trial, refer to clinicaltrials.gov identifier NCT06059846.
- Pursuant to its exclusive license agreement with GSK, Spero received a
$30 million development milestone payment. 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
- Patient enrollment and dosing continues at 26 active sites in the ongoing Phase 2a clinical trial of SPR720, a potential novel first-line oral therapy for nontuberculous mycobacterial pulmonary disease (NTM-PD). 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. Topline data are expected in the second half of 2024. For more information on the trial and its design, see ClinicalTrials.gov identifier NCT05496374.
- A paper, titled Nontuberculous mycobacterial pulmonary disease and the potential role of SPR720 (
Kevin Winthrop et al), was published online,Oct 20, 2023 , in the Expert Review of Anti-infective Therapy. The authors discuss the unmet need in NTM-PD, explaining that current treatment options are limited and the challenges of managing the disease, including length of therapy, poor efficacy, drug intolerance, recurrence, and resistance development. They reviewed data on SPR720 which demonstrated activity against a range of NTM species, including mycobacterium avium complex (MAC) and mycobacterium abscessus (MAB). Encouraging in vitro and pre-clinical data demonstrate that SPR720 is active both alone and in combination with standard-of-care agents, with no evidence of cross-resistance to such agents. The authors concluded that SPR720 should be studied further in the context of a multidrug regimen.
SPR206
- Spero is preparing to advance SPR206, a novel, investigational, IV administered next generation polymyxin antibiotic being developed to treat MDR Gram-negative bacterial infections, into a Phase 2 clinical 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 the Phase 2 clinical trial in the fourth quarter of 2023. Funding of SPR206’s clinical development is currently being provided by the
Department of Defense andNational Institute of Allergy and Infectious Disease . - The results from the Phase 1 bronchoalveolar lavage (BAL) study of SPR206 were published in a paper, titled Pharmacokinetics of SPR206 in Plasma, Pulmonary Epithelial Lining Fluid, and Alveolar Macrophages following
Intravenous Administration to Healthy Adult Subjects (Keith Rodvold et al), in Antimicrobial Agents and Chemotherapy inJune 2023 . The results showed SPR206 to be well-tolerated and achieved lung exposures consistent with predicted therapeutic levels when administered three times daily at 100 mg. - A paper, titled Safety and pharmacokinetics of SPR206 in subjects with varying degrees of renal impairment (
Jon B. Bruss et al), was published in Antimicrobial Agents and Chemotherapy inOctober 2023 . The paper summarizes the results of a study evaluating the safety, tolerability, and pharmacokinetic (PK) of SPR206 with a 100-mg single IV dose in subjects with normal renal function, subjects with varying degrees of renal impairment (RI), and subjects with end-stage renal disease (ESRD) on hemodialysis (HD). SPR206 was generally safe and well-tolerated, and the PK of SPR206 was well characterized in subjects with RI.
Management Update
- Effective
August 1, 2023 , 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,Mr. Shukla succeeded Spero’s prior President and CEO,Ankit Mahadevia , M.D., who became Chairman of the Board of Directors, effectiveAugust 1, 2023 . - On
November 1, 2023 , Spero announced the appointment ofEsther Rajavelu as the Company’s new Chief Financial Officer and Chief Business Officer.Ms. Rajavelu brings over 20 years of experience in growth strategy, investor relations, financing, and M&A.
Third Quarter 2023 Financial Results
Spero reported a net loss for the third quarter ended
Total revenues for the third quarter of 2023 were
Research and development expenses for the third quarter of 2023 were
General and administrative expenses for the third quarter of 2023 were
An impairment expense was incurred in the third quarter of 2023, as the Company concluded that it no longer had need for commercial manufacturing of tebipenem HBr, provided under a service agreement with Savior Lifetec Corporation. An impairment expense of
As of
For further details on Spero’s financials, including results for the nine-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
Investor Relations Contact:
Vice President, Investor Relations and Strategic Finance
IR@sperotherapeutics.com
(617) 798-4039
Media Inquiries:
lora.grassilli@zenogroup.com
646-932-3735
| Condensed Consolidated Balance Sheet Data | |||||
| (in thousands) | |||||
| (Unaudited) | |||||
| 2023 | 2022 | ||||
| Cash, cash equivalents and marketable securities | $ | 93,825 | $ | 109,107 | |
| Other assets | 13,276 | 15,695 | |||
| Total assets | $ | 107,101 | $ | 124,802 | |
| Total liabilities | 53,396 | 48,868 | |||
| Total stockholder's equity | 53,705 | 75,934 | |||
| Total liabilities and stockholders' equity | $ | 107,101 | $ | 124,802 | |
| Condensed Consolidated Statements of Operations | |||||||||||||||
| (in thousands, except share and per share data) | |||||||||||||||
| (unaudited) | |||||||||||||||
| Three Months Ended | Nine Months Ended | ||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||
| Revenues: | |||||||||||||||
| Grant revenue | $ | 2,091 | $ | 924 | $ | 5,349 | $ | 3,843 | |||||||
| Collaboration revenue | 23,382 | 1,082 | 24,910 | $ | 2,225 | ||||||||||
| Total revenues | 25,473 | 2,006 | 30,259 | 6,068 | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | 16,393 | 7,360 | 34,883 | 32,504 | |||||||||||
| General and administrative | 5,708 | 6,632 | 19,121 | 29,988 | |||||||||||
| Impairment of long-term asset | 5,306 | — | 5,306 | — | |||||||||||
| Restructuring | — | (152 | ) | — | 11,697 | ||||||||||
| Total operating expenses | 27,407 | 13,840 | 59,310 | 74,189 | |||||||||||
| Loss from operations | (1,934 | ) | (11,834 | ) | (29,051 | ) | (68,121 | ) | |||||||
| Other income (expense) | 940 | 159 | 2,877 | (5,065 | ) | ||||||||||
| Net loss before income taxes | (994 | ) | (11,675 | ) | (26,174 | ) | (73,186 | ) | |||||||
| Income tax expense | (2,211 | ) | — | (2,211 | ) | — | |||||||||
| Net loss | $ | (3,205 | ) | $ | (11,675 | ) | $ | (28,385 | ) | $ | (73,186 | ) | |||
| Net loss attributable to common shareholders of | $ | (3,205 | ) | $ | (11,675 | ) | $ | (28,385 | ) | $ | (73,186 | ) | |||
| Net loss per share attributable to common shareholders per share, basic and diluted | $ | (0.06 | ) | $ | (0.33 | ) | $ | (0.54 | ) | $ | (2.16 | ) | |||
| Weighted average shares outstanding, basic and diluted: | 52,710,280 | 35,882,076 | 52,603,709 | 33,834,198 | |||||||||||
2023 GlobeNewswire, Inc., source
