Novel Anti-IL-36 Receptor Antibody for the Treatment of Severe Orphan Inflammatory Disorders
SAN DIEGO, April 06, 2017 (GLOBE NEWSWIRE) -- 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.
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: our belief that ANB019 will be effective in inhibiting IL-36R signaling, and for the treatment of GPP and PPP; the timing of completion of our Phase 1 trial of ANB019 and the subsequent release of top-line data from such trial; and the expected timing for initiation of Phase 2 studies for ANB019. Statements including words such as “anticipate,” “believe,” “potential,” “estimate,” “plan,” “will,” “continue,” “expect,” or “future,” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and achieve development goals, the company’s ability to protect intellectual property and other risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
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