Date: 2014-09-29
Type of information: Services contract
Compound: AB103
Company: Atox Bio (Israel) Biomedical Advanced Research and Development Authority (BARDA) (USA)
Therapeutic area: Infectious diseases
Type agreement: services
Action mechanism: AB103 is a rationally designed short peptide acting as a CD28 modulator regulating the host’s inflammatory response.
Disease: necrotizing soft tissue infections (NSTI) and potentially infections caused by biothreats and public health threats that end in sepsis
Details: * On September 29, 2014, Atox Bio, a clinical stage company developing novel immune modulators for severe infections, announced that the Biomedical Advanced Research and Development Authority (BARDA) has awarded Atox Bio with a contract valued up to $24 million and 4.5 years for the development of AB103 to treat Necrotizing Soft Tissue Infections (NSTI) and potentially infections caused by biothreats and public health threats that end in sepsis.
AB103 successfully completed a Phase 2 study in patients with NSTI which are rare, fast progressing infections that result in significant tissue destruction and systemic disease leading to multiple organ dysfunctions. 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.
AB103 is the first product specifically developed for NSTI and has received Orphan Drug status from the FDA and EMA and Fast Track designation from the FDA. The BARDA contract comes in addition to up to $23 million that Atox Bio raised earlier in the year from SR One, OrbiMed and Lundbeckfond.
Financial terms: BARDA awarded the contract to Atox Bio for $4.4M over a base period of 18 months. Subsequent option periods, if exercised by BARDA, would bring the total value of the award to $24 million. The contract covers manufacturing activities, regulatory activities and a pivotal clinical trial of AB103 in patients with NSTI.
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