Regulatory Clearances Support Initiation of Phase 2a Trials for the Treatment of Adult Peanut Allergy and Atopic Dermatitis
SAN DIEGO, CA, USA I December 13, 2016 I AnaptysBio, Inc., a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation, today announced that the United States Food and Drug Administration has cleared the company’s investigational new drug application (IND) for ANB020, a proprietary anti-interleukin-33 antibody, for the treatment of adults with severe peanut allergy, a condition that can result in systemic life-threatening anaphylaxis. In addition, AnaptysBio announced that the United Kingdom Medicines and Healthcare Products Regulatory Agency has cleared the company’s clinical trial authorisation (CTA) for ANB020 for the treatment of adults with moderate-to-severe atopic dermatitis, a challenging type of skin inflammation.
“These regulatory milestones represent important steps forward in the development of ANB020, which we believe has the potential to treat a number of atopic diseases, including severe adult peanut allergy and moderate-to-severe adult atopic dermatitis,” said Hamza Suria, president and chief executive officer of AnaptysBio. “The recently announced topline data from the Phase 1 trial of ANB020 in healthy volunteers demonstrate favorable safety and ex vivo pharmacodynamics of ANB020. We look forward to initiating Phase 2a clinical trials designed to assess the therapeutic potential of ANB020 for the many patients living with atopic conditions.”
AnaptysBio plans to initiate a U.S. Phase 2a trial of ANB020 in adult patients with severe peanut allergy and a U.K. Phase 2a trial in adult patients with moderate-to-severe atopic dermatitis in the first quarter of 2017, and expects to complete both trials during the second half of 2017. In addition, during the first half of 2017, the company plans to seek regulatory clearance to initiate a Phase 2a clinical trial in adult patients with severe eosinophilic asthma, a chronic respiratory disease.
About ANB020
ANB020 is a potent inhibitor of interleukin-33 (IL-33) developed by AnaptysBio using its proprietary SHM antibody discovery platform. IL-33 is a pro-inflammatory cytokine that multiple studies have indicated is a central mediator of atopic diseases, including atopic dermatitis, food allergies and asthma. Since ANB020 acts upstream of IL-4, IL-5 and IL-13, AnaptysBio believes ANB020’s IL-33 inhibitory mechanism has potential advantages in human therapy over agents that block only a subset of the cytokines responsible for atopic diseases. In addition, published human genetic analyses have linked down-modulation of IL-33 signaling with protection from certain atopic diseases.
About AnaptysBio
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 rare 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 SHM platform, which uses in vitro somatic hypermutation 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 partnership with Celgene and TESARO, including an anti-PD-1 antagonist antibody (TSR-042) and an anti-TIM-3 antagonist antibody (TSR-022) currently under clinical development.
SOURCE: AnaptysBio
Post Views: 170
Regulatory Clearances Support Initiation of Phase 2a Trials for the Treatment of Adult Peanut Allergy and Atopic Dermatitis
SAN DIEGO, CA, USA I December 13, 2016 I AnaptysBio, Inc., a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation, today announced that the United States Food and Drug Administration has cleared the company’s investigational new drug application (IND) for ANB020, a proprietary anti-interleukin-33 antibody, for the treatment of adults with severe peanut allergy, a condition that can result in systemic life-threatening anaphylaxis. In addition, AnaptysBio announced that the United Kingdom Medicines and Healthcare Products Regulatory Agency has cleared the company’s clinical trial authorisation (CTA) for ANB020 for the treatment of adults with moderate-to-severe atopic dermatitis, a challenging type of skin inflammation.
“These regulatory milestones represent important steps forward in the development of ANB020, which we believe has the potential to treat a number of atopic diseases, including severe adult peanut allergy and moderate-to-severe adult atopic dermatitis,” said Hamza Suria, president and chief executive officer of AnaptysBio. “The recently announced topline data from the Phase 1 trial of ANB020 in healthy volunteers demonstrate favorable safety and ex vivo pharmacodynamics of ANB020. We look forward to initiating Phase 2a clinical trials designed to assess the therapeutic potential of ANB020 for the many patients living with atopic conditions.”
AnaptysBio plans to initiate a U.S. Phase 2a trial of ANB020 in adult patients with severe peanut allergy and a U.K. Phase 2a trial in adult patients with moderate-to-severe atopic dermatitis in the first quarter of 2017, and expects to complete both trials during the second half of 2017. In addition, during the first half of 2017, the company plans to seek regulatory clearance to initiate a Phase 2a clinical trial in adult patients with severe eosinophilic asthma, a chronic respiratory disease.
About ANB020
ANB020 is a potent inhibitor of interleukin-33 (IL-33) developed by AnaptysBio using its proprietary SHM antibody discovery platform. IL-33 is a pro-inflammatory cytokine that multiple studies have indicated is a central mediator of atopic diseases, including atopic dermatitis, food allergies and asthma. Since ANB020 acts upstream of IL-4, IL-5 and IL-13, AnaptysBio believes ANB020’s IL-33 inhibitory mechanism has potential advantages in human therapy over agents that block only a subset of the cytokines responsible for atopic diseases. In addition, published human genetic analyses have linked down-modulation of IL-33 signaling with protection from certain atopic diseases.
About AnaptysBio
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 rare 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 SHM platform, which uses in vitro somatic hypermutation 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 partnership with Celgene and TESARO, including an anti-PD-1 antagonist antibody (TSR-042) and an anti-TIM-3 antagonist antibody (TSR-022) currently under clinical development.
SOURCE: AnaptysBio
Post Views: 170
