– Favorable Safety and Pharmacodynamic Parameters Demonstrated in Healthy Volunteers –
– US IND and UK CTA Filings Submitted To Enable Multiple Phase 2 Trials –
SAN DIEGO, CA, USA I October 3, 2016 I AnaptysBio, Inc., a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation and immuno-oncology, today announced top-line results from a single and multiple ascending dose Phase 1 trial of ANB020, a novel anti-interleukin-33 (IL-33) therapeutic antibody.
In the double-blind, placebo-controlled Phase 1 trial, 96 healthy volunteer subjects were dosed with either a single subcutaneous or intravenous dose of ANB020 ranging between 10 mg and 750 mg, or four multiple doses of ANB020 ranging between 40 mg and 300 mg over a period of four consecutive weeks. ANB020 was well-tolerated and no dose-limiting toxicities were observed at any dose level. An ex vivo pharmacodynamic assay illustrated that a single dose of ANB020 at certain dose levels was sufficient to suppress IL-33 function for approximately three months post-dosing. AnaptysBio plans to report detailed results from this Phase 1 trial at a future scientific conference.
“We continue to be excited by ANB020’s potential to treat patients suffering from IL-33-mediated inflammatory conditions,” said Hamza Suria, President & CEO of AnaptysBio. “As the only known anti-IL-33 cytokine antibody in clinical development, ANB020 intervenes upstream of IL-4, IL-5 and IL-13 cytokine release and therefore has a potential mechanistic advantage for the treatment of atopic dermatitis, food allergies and asthma. We look forward to generating proof-of-concept data for ANB020 in multiple clinical indications over the upcoming 12 months.”
AnaptysBio plans to conduct Phase 2 clinical trials of ANB020 in multiple patient populations, including moderate-to-severe adult atopic dermatitis, severe adult peanut allergy and uncontrolled adult eosinophilic asthma. The company recently submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) and a Clinical Trial Application (CTA) to the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) for ANB020 to enable Phase 2 trials. The aforementioned Phase 1 trial was conducted in Australia under an approved Clinical Trial Notification (CTN).
About ANB020
ANB020 is a potent inhibitor of interleukin-33 (IL-33) developed by AnaptysBio using its proprietary SHM-XEL 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 broadly across the key cell types and cytokines involved in atopy, 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, the role of IL-33 signaling in asthma has been recently genetically validated through human studies published in medical literature.
About AnaptysBio
AnaptysBio is a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation and immuno-oncology. The Company’s proprietary anti-inflammatory pipeline includes its anti-IL-33 antibody (ANB020) for the treatment of atopic dermatitis, asthma and peanut allergy, its anti-IL-36R antibody (ANB019) for the treatment of generalized pustular psoriasis and palmo-plantar pustulosis, and a portfolio of checkpoint agonist antibodies for the treatment of autoimmune disease. AnaptysBio’s antibody pipeline has been developed using its proprietary SHM-XEL platform, which has pioneered the use of in vitro somatic hypermutation for antibody discovery and is designed to replicate key features of the human immune system to overcome the limitations of prior antibody technologies. AnaptysBio has also developed multiple therapeutic antibodies in partnership with Celgene and TESARO, including an anti-PD-1 antibody (TSR-042) and an anti-TIM-3 antibody (TSR-022) currently under clinical development.
SOURCE: AnaptysBio
Post Views: 139
– Favorable Safety and Pharmacodynamic Parameters Demonstrated in Healthy Volunteers –
– US IND and UK CTA Filings Submitted To Enable Multiple Phase 2 Trials –
SAN DIEGO, CA, USA I October 3, 2016 I AnaptysBio, Inc., a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation and immuno-oncology, today announced top-line results from a single and multiple ascending dose Phase 1 trial of ANB020, a novel anti-interleukin-33 (IL-33) therapeutic antibody.
In the double-blind, placebo-controlled Phase 1 trial, 96 healthy volunteer subjects were dosed with either a single subcutaneous or intravenous dose of ANB020 ranging between 10 mg and 750 mg, or four multiple doses of ANB020 ranging between 40 mg and 300 mg over a period of four consecutive weeks. ANB020 was well-tolerated and no dose-limiting toxicities were observed at any dose level. An ex vivo pharmacodynamic assay illustrated that a single dose of ANB020 at certain dose levels was sufficient to suppress IL-33 function for approximately three months post-dosing. AnaptysBio plans to report detailed results from this Phase 1 trial at a future scientific conference.
“We continue to be excited by ANB020’s potential to treat patients suffering from IL-33-mediated inflammatory conditions,” said Hamza Suria, President & CEO of AnaptysBio. “As the only known anti-IL-33 cytokine antibody in clinical development, ANB020 intervenes upstream of IL-4, IL-5 and IL-13 cytokine release and therefore has a potential mechanistic advantage for the treatment of atopic dermatitis, food allergies and asthma. We look forward to generating proof-of-concept data for ANB020 in multiple clinical indications over the upcoming 12 months.”
AnaptysBio plans to conduct Phase 2 clinical trials of ANB020 in multiple patient populations, including moderate-to-severe adult atopic dermatitis, severe adult peanut allergy and uncontrolled adult eosinophilic asthma. The company recently submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) and a Clinical Trial Application (CTA) to the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) for ANB020 to enable Phase 2 trials. The aforementioned Phase 1 trial was conducted in Australia under an approved Clinical Trial Notification (CTN).
About ANB020
ANB020 is a potent inhibitor of interleukin-33 (IL-33) developed by AnaptysBio using its proprietary SHM-XEL 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 broadly across the key cell types and cytokines involved in atopy, 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, the role of IL-33 signaling in asthma has been recently genetically validated through human studies published in medical literature.
About AnaptysBio
AnaptysBio is a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation and immuno-oncology. The Company’s proprietary anti-inflammatory pipeline includes its anti-IL-33 antibody (ANB020) for the treatment of atopic dermatitis, asthma and peanut allergy, its anti-IL-36R antibody (ANB019) for the treatment of generalized pustular psoriasis and palmo-plantar pustulosis, and a portfolio of checkpoint agonist antibodies for the treatment of autoimmune disease. AnaptysBio’s antibody pipeline has been developed using its proprietary SHM-XEL platform, which has pioneered the use of in vitro somatic hypermutation for antibody discovery and is designed to replicate key features of the human immune system to overcome the limitations of prior antibody technologies. AnaptysBio has also developed multiple therapeutic antibodies in partnership with Celgene and TESARO, including an anti-PD-1 antibody (TSR-042) and an anti-TIM-3 antibody (TSR-022) currently under clinical development.
SOURCE: AnaptysBio
Post Views: 139
