- Multiple ascending dose clinical data supports advancement of 600 mg TID dose for pivotal Phase 3 clinical trial, planned for initiation around year-end 2018
- 600 mg dose provides greater drug exposure than 300 mg dose with comparable safety profile
“The final Phase 1 data demonstrate compelling pharmacokinetics, safety and tolerability for SPR994 at all doses tested,” said
The Phase 1 SAD/MAD clinical trial assessed the safety, tolerability and pharmacokinetics of orally administered SPR994. The Phase 1 clinical trial enrolled 124 healthy adult volunteers into 14 SAD cohorts with SPR994 given orally as single doses ranging from 100 mg to 900 mg daily and 2 MAD cohorts with SPR994 given orally at doses of 300 mg and 600 mg every 8 hours for 14 days. Final results demonstrated a linear and proportional increase in plasma exposure over the dose range tested, with no accumulation over 14 days of repeated dosing. Furthermore, the administration of SPR994 in the fed or fasting state did not substantially alter the plasma drug exposure, indicating that SPR994 can likely be administered without regard to meals. Consistent with the predominantly renal elimination of SPR994, peak urine concentrations were approximately 50 to 100-fold higher than maximum concentrations in plasma, supporting SPR994’s potential utility as treatment for patients with cUTI.
The final Phase 1 results build upon the interim results announced in July 2018. Those results demonstrated that in the SAD portion of the Phase 1 clinical trial, SPR994 was well tolerated at doses ranging from 100 mg to 900 mg daily. Those results also showed that in the MAD portion of the trial, the 300 mg TID dose of SPR994 demonstrated mean free drug plasma concentrations of tebipenem, SPR994’s active metabolite, that remained above the MIC90 for the relevant bacterial pathogens for >50% of an 8-hour dosing interval, which supports the selected TID dosing interval.
No serious adverse events were reported in the Phase 1 clinical trial. Oral administration of SPR994 was well tolerated at all doses tested within the trial, and the Phase 1 results are consistent with available clinical and post-marketing data for Orapenem® and other approved intravenous (IV) carbapenem antibiotics. Orapenem® is currently approved in
Spero has scheduled a pre-Phase 3 meeting with the
SPR994 is Spero’s novel investigational oral formulation of tebipenem, a carbapenem-class antibiotic marketed by Meiji Seika Pharma Co. Ltd. (
Spero Therapeutics is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multidrug-resistant (MDR) bacterial infections.
Spero is advancing SPR994, a carbapenem-class antibiotic, 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 the development of drugs that will expand the spectrum and potency of existing antibiotics, including formerly inactive antibiotics, against Gram-negative bacteria. The product candidates are two 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 (NTM) infection, an orphan infectious disease indication.
For more information, visit https://sperotherapeutics.com.
Forward Looking Statements
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 the Company’s preclinical studies and clinical trials and the Company’s research and development programs, including statements regarding management’s assessment of the results of such preclinical studies and clinical trials, the timing of initiating a Phase 3 clinical trial of SPR994, the potential of SPR994, the Company’s cash forecast and anticipated expenses and the sufficiency of the Company’s cash resources. 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 the Company’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 United States Food and Drug Administration or equivalent foreign regulatory agencies; whether the Company’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
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Director, Investor Relations
Source: Spero Therapeutics, Inc.