Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections in Subjects for Whom Chronic Antibiotic Suppressive Therapy is Indicated

Prospective, open-label, non-randomized, single-arm trial to evaluate the safety and
effectiveness of CEM-102 for chronic antibiotic suppressive therapy of bone or joint
infections. Subjects enrolling in this study must have a refractory staphylococcal bone or
joint infection that requires suppressive antibiotic therapy (e.g. having an infection that
cannot be managed by complete removal of the infected bone or foreign material, a refractory
infection not responding to previous treatment, or not being a candidate for long-term
intravenous antibiotic therapy).

Inclusion Criteria:

- Adolescents between 12 and 18 years must weigh >60 kg

- Bone or joint infection due to an inclusionary pathogen demonstrated from a culture
from samples obtained within 6 weeks prior to enrollment

- Not a candidate, as determined by the Investigator, for suitable alternative therapy

- After completion of 1-2 weeks of the companion antibiotic, must be a suitable
candidate for CEM-102 monotherapy for chronic treatment

Exclusion Criteria:

- Requires concomitant treatment with OATP1B1 and OATP1B3 substrates, in particular,
statins (HMG-CoA reductase inhibitors)

- Known severe renal impairment, as indicated by estimated CrCl <30 mL/min (by
Cockcroft-Gault calculation)

- Evidence of significant liver disease: ALT >3 × ULN or direct bilirubin >ULN; known
cirrhosis with decompensation (i.e. Child-Pugh Class B or C disease)