The translated heading in English is: "Spero stops development of SPR720 - Restructuring in focus.

Eulerpool Research Systems Oct 30, 2024

Takeaways NEW

  • Spero Therapeutics halts development of SPR720 and plans staff reductions.
  • Company focuses on other antibiotic programs and has sufficient financial resources until 2026.
The biotechnology company Spero Therapeutics has halted the development of its antibiotic SPR720 after the treatment failed to meet the primary study objective in a Phase IIa trial for patients with non-tuberculous mycobacterial lung disease. Despite demonstrated antimicrobial activity, SPR720 was unable to show a sufficient difference compared to placebo in the interim analysis. As a result, Spero plans to reduce its workforce by 39%. This news has caused Spero's stock to drop more than 17% in pre-market trading. Nonetheless, the company reports having sufficient financial resources to maintain operations until mid-2026. The study (NCT05496374) included 25 non-refractory patients and showed no significant change in colony formation in 16 participants, the primary endpoint of the investigation. Safety concerns with potentially dose-limiting adverse effects, including three cases of Grade 3 hepatotoxicity, were observed at a dosage of 1,000 mg once daily. Moving forward, Spero intends to focus its resources on two other antibiotic programs: the oral carbapenem antibiotic tebipenem HBr and SPR206, a next-generation polymyxin. Tebipenem HBr has been licensed to GSK, which holds global marketing rights (excluding certain Asian countries). Under this partnership, Spero has thus far received $143.5 million and could generate additional milestone payments and tiered royalties from sales. The Phase III PIVOT-PO study (NCT06059846) will compare oral tebipenem HBr with a combination of the intravenous antibiotics imipenem and cilastatin in hospitalized adults with complicated urinary tract infections. The recruitment of approximately 2,648 patients is expected to be completed by the end of 2025. For SPR206, Spero plans a trial for the treatment of multidrug-resistant gram-negative pathogens in patients with hospital or ventilator-associated bacterial pneumonia. The U.S. FDA has already granted approval for a Phase II study, the start of which depends on non-dilutive financing. Following its recent wave of layoffs, Spero joins the ranks of pharmaceutical companies like Aerovate Therapeutics, Sage Therapeutics, and Shattuck Labs, which have made workforce reductions to enhance their financial commitment to clinical development.

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