Date: 2014-06-23
Type of information: Granting of the orphan status in the EU
Product name: AB103 - sodium acetate salt of the synthetic peptide H-D-Ala-Ser-Pro-Met-Leu-Val-Ala-Tyr-Asp-D-Ala-OH
Compound: sodium acetate salt of the synthetic peptide H-D-Ala-Ser-Pro-Met-Leu-Val-Ala-Tyr-Asp-D-Ala-OH
Therapeutic area: Rare diseases - Infectious diseases
Action mechanism: AB103, a novel immunomodulator, is a short peptide that modulates the host’s inflammatory response through binding to the CD28 dimer interface. It offers a unique approach in the treatment of infectious diseases by modulating, but not inhibiting, the host immune system. This approach of targeting the host response rather than the pathogen precludes the rapid generation of drug resistance and provides a multisystem solution for bacterial infections with broad-spectrum coverage, independent of pathogen type.
Company: Dr Ulrich Granzer (Germany) - Atox Bio (Israel)
Disease: necrotising soft tissue infections
Latest news: * On August 5, 2014, Atox Bio announced that the European Commission has granted AB103 (Sodium acetate salt of the synthetic peptide H-D-Ala-Ser-Pro-Met-Leu-Val-Ala-Tyr-Asp-D-Ala-OH) orphan medicinal product designation (EU/3/14/1294) for the treatment of necrotizing soft tissue infections. Atox Bio is represented in the EU by Dr. Ulrich Granzer as agent. * On June 13, 2014, the Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending the granting of an orphan designation for sodium acetate salt of the synthetic peptide H-D-Ala-Ser-Pro-Met-Leu-Val-Ala-Tyr-Asp-D-Ala-OH for treatment for necrotising soft tissue infections. * On September 10, 2012, Atox Bio has announced that the FDA has granted Fast Track designation to AB103, its lead product, currently in development for the treatment of Necrotizing Soft Tissue Infections (NSTI). Atox Bio completed recruitment of 40 patients in a phase 2 proof of concept study evaluating AB103’s clinical benefit when administered in addition to standard of care. Efficacy data from these 40 patients is expected by the end of this year. * On October 25, 2011, Atox Bio has announced that the FDA has granted orphan drug designation for AB103 for the treatment of necrotizing soft tissue infections.
AB103 successfully completed a Phase 2 study in patients with NSTI. The results demonstrated that patients treated with AB103 had a meaningful improvement across multiple end points. Patients treated with AB103 had a faster resolution of organ dysfunction, spent fewer days in the intensive care unit, required fewer days of assisted ventilation and needed fewer surgical procedures to remove infected tissue. A pivotal study is planned for the second half of 2015.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA: 2011-10-25
Orphan status UE: 2014-07-29
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
