Taksta Explained

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.^[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 a phase 3 clinical trial of Taksta in acute bacterial skin and skin structure infections.^[5]

Nov 2016: Cempra completes a phase 3 clinical trial of Taksta in acute bacterial skin and skin structure infections. Results remain pending.^[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 infection is 100 percent (99/99) at both the EOT and PTE visits.^[7]

See also

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

Notes and References

1. Web site: Cempra Announces Expansion of Clinical Management Team to Advance Leading Antibacterial Clinical Programs Taksta and CEM-101 .
2. Web site: Safety and Efficacy of CEM-102 Compared to Linezolid in Acute Bacterial Skin Infections . 15 April 2019 .
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 safety 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. Web site: Cempra Doses First Patient in Phase 3 Clinical Trial of Taksta in Acute Bacterial Skin and Skin Structure Infections . investor.cempra.com . 16 April 2023 . https://web.archive.org/web/20160805114430/http://investor.cempra.com/releasedetail.cfm?releaseid=946010 . August 5, 2016 . en . December 8, 2015.
6. Web site: Oral Sodium Fusidate (CEM-102) Versus Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections. ClinicalTrials.gov. FDA. 17 December 2016.
7. Web site: Cempra's Fusidic Acid Achieves Primary Endpoint in Phase 3 Study of ABSSSI. Cempra.com. Cempra. 4 April 2017.