Date: 2017-06-01
Type of information: Treatment of the first patient
phase: 1
Announcement: treatment of the first patient
Company: Achaogen (US - CA)
Product: C-Scape (ACHN-383 and ACHN-789)
Action mechanism: antibiotic. C-Scape is a combination of an approved beta-lactam and an approved beta-lactamase inhibitor. C-Scape has been awarded Qualified Infectious Disease Product (QIDP) status by FDA for the treatment of cUTI, including acute pyelonephritis (AP). QIDP designation provides incentives for new antibiotic treatments, including priority review and additional market exclusivity. The Company's preclinical studies have confirmed C-Scape's potent in vitro microbiologic activity against ESBL-producing Enterobacteriaceae and its potential to achieve efficacious exposures with an oral dosing regimen.
Disease:
Therapeutic area: Infectious diseases
Country: Australia
Trial details: This Phase 1 clinical trial is a double-blind, randomized, placebo-controlled, parallel group study to assess the safety, tolerability and clinical pharmacology of C-Scape (ACHN-383 and ACHN-789), administered orally, in healthy subjects with and without renal impairment. Healthy subjects with moderate to severe renal impairment are being included because, in practice, renal impairment is a common comorbidity in patients with cUTI due to MDR pathogens including ESBL-producing Escherichia coli and Klebsiella pneumoniae. (NCT03163550)
Latest news: • On June 1, 2017, Achaogen announced that it has dosed the first patient with C-Scape in a Phase 1 clinical pharmacology, dosing and safety study. C-Scape is a combination of an approved beta-lactam and an approved beta-lactamase inhibitor. With the C-Scape program, Achaogen plans for a rapid development and regulatory approach that leverages a 505(b)(2) path that, if the Phase 1 is successful, supports the initiation of a single pivotal Phase 3 trial in the first half of 2018.
