AnaptysBio Announces First-In-Human Dosing of ANB019
- Category: Antibodies
- Published on Thursday, 06 April 2017 14:30
- Hits: 1012
SAN DIEGO, CA, USA I April 6, 2017 I AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation, today announced first-in-human dosing of its wholly-owned proprietary anti-Interleukin-36 receptor (IL-36R) antibody, ANB019, in a healthy volunteer Phase 1 clinical trial. The double-blind, placebo-controlled, single and multiple ascending dose trial is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ANB019 through subcutaneous and intravenous routes of administration.
Excess signaling through the IL-36R is associated with two orphan inflammatory conditions known as generalized pustular psoriasis (GPP) and palmo-plantar pustular psoriasis (PPP). GPP is a life-threatening, systemic inflammatory disorder associated with widespread pustulosis throughout the body, which affects approximately 3,000 patients in the United States. PPP is a non-fatal condition associated with inflammatory pustules on the hands and feet affecting approximately 150,000 patients in the United States. ANB019 has the potential to become the first therapy approved for the treatment of GPP and PPP.
“We are excited to initiate clinical development of ANB019 and further advance our proprietary pipeline of antibody therapeutics,” said Hamza Suria, president and chief executive officer of AnaptysBio. “GPP and PPP are severely debilitating orphan diseases with no currently approved therapeutic options. IL-36 signaling dysfunction is known to play a key role in these diseases and we look forward to developing ANB019 for the benefit of patients living with GPP and PPP.”
The Phase 1 trial of ANB019 is being conducted under an Australian Clinical Trial Notification (CTN) and top-line data are expected during the second half of 2017. AnaptysBio subsequently plans to seek regulatory clearance to initiate Phase 2 studies of ANB019 in patients with GPP and PPP during 2018.
AnaptysBio is a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation. The company’s proprietary anti-inflammatory pipeline includes its anti-IL-33 antibody (ANB020) for the treatment of moderate-to-severe adult atopic dermatitis, severe adult peanut allergy and severe adult eosinophilic asthma; its anti-IL-36R antibody (ANB019) for the treatment of orphan inflammatory diseases, including generalized pustular psoriasis and palmo-plantar pustular psoriasis; and a portfolio of checkpoint receptor agonist antibodies for the treatment of certain autoimmune diseases where immune checkpoint receptors are insufficiently activated and have demonstrated efficacy in an animal model of graft-versus-host disease. AnaptysBio’s antibody pipeline has been developed using its proprietary somatic hypermutation (SHM) platform, which uses in vitro SHM for antibody discovery and is designed to replicate key features of the human immune system to overcome the limitations of competing antibody discovery technologies. AnaptysBio has also developed multiple therapeutic antibodies in an immuno-oncology partnership with TESARO and an inflammation partnership with Celgene, including an anti-PD-1 antagonist antibody (TSR-042) and an anti-TIM-3 antagonist antibody (TSR-022), which are currently under clinical development with TESARO, and an anti-PD-1 checkpoint agonist antibody (CC-90006) currently in the clinic with Celgene. For more information, please visit www.anaptysbio.com.