Northland Capital partners view on MotifBio PLC: This fixed dose regime is important for the iclaprim Phase 3 trials, in that it optimises pharmacodynamic parameters associated with antibacterial efficacy, while potentially minimising safety events. As such, a fixed dose regime considerably improves the likelihood of a successful trial.
| Motif received FDA concurrence of optimised dose for iclaprim Phase 3 clinical trials | ||||||||||||||||||||||||||||||||||||||||||||||||||
| n Motif has received written concurrence from the US FDA for an optimised fixed dose of iclaprim of 80mg for all patients (except those with moderate hepatic impairment), regardless of bodyweight, in the company’s proposed Phase 3 clinical trials for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
n In particular, the fixed dose regime can help reduce the time required for dosage adjustment or monitoring by healthcare professionals in renally impaired or obese patients, leading to reduced overall hospital treatment costs in these high risk patient populations. n Obesity can affect the pharmacokinetics and pharmacodynamics of many drugs, including antimicrobial therapies, potentially leading to suboptimal drug concentrations in serum or tissue. n Obese patients have been found to be at risk for clinical failure following inadequate dosing of antimicrobial therapy. n Studies have found that hospitalised patients with ABSSSI have a higher occurrence of obesity and renal impairment than in the general adult population. |
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Source: Northland Capital Partners Limited.
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