Atox Bio Announces Chief Commercial Officer Appointment

Atox Bio announced the appointment of Robert Greif as Chief Commercial Officer. In this newly created position, Greif will be responsible for building the commercial organization and pre-commercial activities for Reltecimod, assuming the product is successfully developed and approved by regulatory authorities. Reltecimod is the company's lead product in development and is currently in late stage clinical trials for Necrotizing Soft Tissue Infections (NSTI, "flesh eating bacteria") and Sepsis-associated Acute Kidney Injury (AKI) with results of the ACCUTE, Phase 3 study in NSTI expected by year-end.

"Robert possesses in-depth knowledge in value-based commercialization, market access, and specialty product launches for hospital-based therapies," said Dan Teleman, Chief Executive Officer of Atox Bio. "He is a key addition to the Atox Bio management team as we get closer to completing the ACCUTE, Phase 3 study later this year. We look forward to benefitting from his experience as we prepare to bring to market the first product specifically developed for treating NSTI next year."

Most recently, Greif led all aspects of commercial operations at rEVO Biologics, an orphan disease biotechnology company targeted at hospital-based hematology, hemophilia and critical care communities. Prior to this, he worked for UnitedHealth Group as Senior Vice President, Global Business Development. Before that, Greif held a variety of sales, marketing and market access leadership roles at Boehringer Ingelheim and Sanofi where driving demand and reimbursement in the commercial, government and hospital channels were integral to the launch of various blockbuster products including Plavix, Flomax and Spiriva.

"I am impressed with the clinical development program for Reltecimod both for NSTI and AKI and excited about the potential of bringing a new treatment to patients suffering from these devastating diseases," said Mr. Greif. "Joining Atox Bio at this pivotal moment of its development offers a unique opportunity to be part of the team that will deliver its vision for the benefit of patients."

Reltecimod (AB103) is a rationally designed peptide that binds to the CD28 co-stimulatory receptor and restores the host's appropriate immune response to severe infections. By modulating, but not inhibiting, the body's acute inflammatory response, Reltecimod is designed to help control the cytokine storm that could otherwise quickly lead to morbidity and mortality. Reltecimod received Orphan Drug status from the FDA and EMA as well as Fast Track designation for the NSTI indication.

NSTI, commonly referred to as "flesh eating bacteria", represent the most severe types of infections involving soft tissues. NSTI progress rapidly and often result in significant tissue destruction and systemic disease leading to multiple organ failure and death. NSTI are rare with an estimated 28,000 patients annually in the US. Currently, there are no approved treatments for NSTI. The standard of care includes prompt and repeated surgical debridement, aggressive resuscitation and physiologic support, in addition to antibiotics.

The Phase 3 ACCUTE (AB103 Clinical Composite endpoint study in necrotizing soft tissue infections) is an ongoing randomized, placebo-controlled study that plans to enroll 290 patients with NSTI at approximately 60 level 1 trauma sites in the US. Patients receive Reltecimod or placebo, administered as a single dose during or shortly after surgical debridement, in addition to standard of care treatment. The primary end point is a clinical composite that evaluates both the local and systemic components of this disease.

Acute Kidney Injury (AKI) involves inflammatory processes in the kidney which can lead to permanent reduction of kidney function and is also associated with an increased risk of death, extended hospitalization, and increased medical cost. There are currently no approved therapies to treat AKI and the only treatment options are dialysis and supportive care.

The phase 2 REAKT (Reltecimod Efficacy for Acute Kidney Injury Trial) is an ongoing randomized, placebo-controlled study, that plans enroll 120 patients with abdominal sepsis and stage 2/3 AKI (as described by KDIGO criteria) at approximately 80 centers in the U.S and Europe. Patients receive Reltecimod or placebo, administered as a single dose after the diagnosis of AKI, in addition to standard of care treatment. The primary endpoint is complete recovery from stage 2/3 AKI, defined as alive, free of dialysis and return of serum creatinine to <150% of reference baseline.

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