Taksta

Taksta (previously CEM-102) is a front-loaded oral dosing regimen of sodium fusidate under development in the U.S. as an antibiotic for gram-positive infections including drug-resistant strains such as methicillin-resistant Staphylococcus aureus (MRSA).[1]

Clinical trials

Jan 2010: Taksta has completed enrollment in a Phase 2 trial (due to run until March 2010) and is preparing for Phase 3 studies in the U.S. for acute bacterial skin structure infections (being compared with Linezolid). [2]

Sep 2010: Taksta demonstrated comparable clinical success rates compared to linezolid in a Phase 2 trial in the U.S. for acute bacterial skin and skin structure infections.[3]

Jun 2011: Taksta may be effective in the treatment of chronic prosthetic joint infections and osteomyelitis.[4]

Dec 2015: Cempra Doses First Patient in Phase 3 Clinical Trial of Taksta(TM) in Acute Bacterial Skin and Skin Structure Infections. (2015) [5]

Nov 2016: Cempra completes Phase 3 Clinical Trial of Taksta(TM) in Acute Bacterial Skin and Skin Structure Infections. Results remain pending. (2016) [6]

Feb 2017: Cempra achieves the primary endpoint of a 10% non-inferiority margin. The microbiological success in each ME population with methicillin-resistant S. aureus (MRSA) infection is 100 percent (99/99) at both the EOT and PTE visits. (2017) [7]

See also
  • Fusidic acid, licensed for some decades outside the US and is in clinical development in the U.S.

References
  1. "Cempra Announces Expansion of Clinical Management Team to Advance Leading Antibacterial Clinical Programs TAKSTA(TM) and CEM-101".
  2. "Safety and Efficacy of CEM-102 Compared to Linezolid in Acute Bacterial Skin Infections". 15 April 2019. {{cite journal}}: Cite journal requires |journal= (help)
  3. Craft JC, Moriarty SR, Clark K, Scott D, Degenhardt TP, Still JG, Corey GR, Still JG, Das A, Fernandes P (2011). "A randomized, double-blind Phase 2 study comparing the efficacy and safeety of an oral fusidic acid loading-dose regimen to oral linezolid in the treatment of acute bacterial skin and skin structure infections." Clinical Infectious Diseases 52(Supplement 7):S520-S226.
  4. Wolfe CR. (2011) "Case report: treatment of chronic osteomyelitis." Clinical Infectious Diseases 52(Supplement 7):S538-S541.
  5. Cempra Press Release. Cempra Company http://investor.cempra.com/releasedetail.cfm?releaseid=946010. Retrieved 17 December 2016. {{cite web}}: Missing or empty |title= (help)
  6. "Oral Sodium Fusidate (CEM-102) Versus Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections". ClinicalTrials.gov. FDA. Retrieved 17 December 2016.
  7. "Cempra's Fusidic Acid Achieves Primary Endpoint in Phase 3 Study of ABSSSI". Cempra.com. Cempra. Retrieved 4 April 2017.


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