Preclinical data with APG808 demonstrate the potential for improved dosing over other treatment options in development, including the potential for dosing every six- or eight- weeks compared to dosing every two weeks for other biologics in development
Second product candidate to enter the clinic following positive interim results from Phase 1 Healthy Volunteer Trial for APG777, which exceeded all of its trial objectives
Interim subcutaneous safety and pharmacokinetic data from healthy volunteers anticipated in 2H 2024
SAN FRANCISCO, CA and WALTHAM, MA, USA I March 25, 2024 I Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis (AD), COPD, asthma and other inflammatory and immunology (I&I) indications, today announced that it has initiated dosing of healthy volunteers in its first clinical trial for APG808, a novel subcutaneous (SQ) extended half-life monoclonal antibody (mAb) targeting IL-4Rα, which is being developed as a treatment for people living with moderate-to-severe COPD, asthma and other I&I diseases.
“On the heels of announcing positive interim data from our Phase 1 APG777 clinical trial, the initiation of the APG808 Phase 1 healthy volunteer trial represents another important advancement for Apogee’s portfolio of differentiated and optimized biologics,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “Launching our second clinical program, ahead of initial timeline expectations, brings us one step closer to providing potentially best-in-class biologics designed to significantly improve therapeutic options for patients with I&I diseases and further builds our track record of execution.”
APG808 is a novel, SQ extended half-life mAb targeting IL-4Rα, a target with clinical validation across eight Type 2 allergic diseases. APG808 has similar binding and femtomolar affinity for IL-4Rα as compared to a first-generation mAb, DUPIXENT, and has demonstrated similar inhibition to DUPIXENT across three in vitro assays, which measure downstream functional inhibition of the IL-13/IL-4 pathway (pSTAT6 induction, inhibition of TF-1 proliferation, and inhibition of TARC secretion). COPD is a progressive respiratory disease that is estimated to affect approximately 10 percent of the global population 40 years of age and older. Despite recent advancements in COPD treatment, a significant number of people continue to suffer and die from the disease.
The APG808 Phase 1 trial is designed as a double-blind, placebo-controlled, first-in-human, single-ascending dose trial in healthy volunteers. The study will evaluate the safety, tolerability and pharmacokinetics (PK) of APG808 and is expected to enroll approximately 32 healthy adults into four cohorts. Apogee expects interim data from the trial in the second half of 2024, and, pending positive results from the Phase 1 trial and following the submission of an IND or foreign equivalent, plans to initiate a potential Phase 1b trial in asthma with a data readout in the first half of 2025 and a randomized, placebo-controlled Phase 2 clinical trial in patients with moderate-to-severe COPD in 2025.
“By targeting known biologic drivers of disease and utilizing advanced antibody engineering such as improved half-life, Apogee aims to overcome limitations of existing therapies for I&I diseases,” said Carl Dambkowski, M.D., Chief Medical Officer of Apogee. “We demonstrated the potential benefits of optimizing antibody properties with APG777 and now hope to do the same with APG808, which, in head-to-head preclinical studies, demonstrated similar potency to current therapies but with a significantly longer half-life. Importantly, this points to potentially less frequent dosing for patients with COPD, which could significantly improve quality of life.”
About APG808
APG808 is a novel, subcutaneous extended half-life monoclonal targeting IL-4Rα, a target with clinical validation across eight Type 2 allergic diseases, for the potential treatment of chronic obstructive pulmonary disease (COPD), asthma and other inflammatory and immunology indications. APG808 has similar binding and femtomolar affinity for IL-4Rα as compared to a first generation mAb, DUPIXENT, and has demonstrated similar inhibition to DUPIXENT across three in vitro assays which measure downstream functional inhibition of the IL-13/IL-4 pathway (pSTAT6 induction, inhibition of TF-1 proliferation, and inhibition of TARC secretion). COPD is a progressive respiratory disease that is estimated to affect approximately 10 percent of the global population 40 years of age and older. Despite recent advancements in COPD treatment, a significant number of people continue to suffer and die from the disease. A Phase 1 clinical trial of APG808 in healthy volunteers is ongoing, and the company expects interim safety and pharmacokinetic data in the second half of 2024. Pending data from the Phase 1 trial, the company plans to initiate a potential Phase 1b trial in asthma with a data readout in in the first half of 2025 and a randomized, placebo-controlled Phase 2 clinical trial in patients with moderate-to-severe COPD in 2025.
About Apogee
Apogee Therapeutics is a clinical-stage biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis (AD), chronic obstructive pulmonary disease (COPD), asthma and other inflammatory and immunology indications with high unmet need. Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. The company’s two most advanced programs are APG777 and APG808, which are being initially developed for the treatment of AD and COPD, respectively. Based on a broad pipeline and depth of expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. For more information, please visit www.apogeetherapeutics.com.
SOURCE: Apogee Therapeutics
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Preclinical data with APG808 demonstrate the potential for improved dosing over other treatment options in development, including the potential for dosing every six- or eight- weeks compared to dosing every two weeks for other biologics in development
Second product candidate to enter the clinic following positive interim results from Phase 1 Healthy Volunteer Trial for APG777, which exceeded all of its trial objectives
Interim subcutaneous safety and pharmacokinetic data from healthy volunteers anticipated in 2H 2024
SAN FRANCISCO, CA and WALTHAM, MA, USA I March 25, 2024 I Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis (AD), COPD, asthma and other inflammatory and immunology (I&I) indications, today announced that it has initiated dosing of healthy volunteers in its first clinical trial for APG808, a novel subcutaneous (SQ) extended half-life monoclonal antibody (mAb) targeting IL-4Rα, which is being developed as a treatment for people living with moderate-to-severe COPD, asthma and other I&I diseases.
“On the heels of announcing positive interim data from our Phase 1 APG777 clinical trial, the initiation of the APG808 Phase 1 healthy volunteer trial represents another important advancement for Apogee’s portfolio of differentiated and optimized biologics,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “Launching our second clinical program, ahead of initial timeline expectations, brings us one step closer to providing potentially best-in-class biologics designed to significantly improve therapeutic options for patients with I&I diseases and further builds our track record of execution.”
APG808 is a novel, SQ extended half-life mAb targeting IL-4Rα, a target with clinical validation across eight Type 2 allergic diseases. APG808 has similar binding and femtomolar affinity for IL-4Rα as compared to a first-generation mAb, DUPIXENT, and has demonstrated similar inhibition to DUPIXENT across three in vitro assays, which measure downstream functional inhibition of the IL-13/IL-4 pathway (pSTAT6 induction, inhibition of TF-1 proliferation, and inhibition of TARC secretion). COPD is a progressive respiratory disease that is estimated to affect approximately 10 percent of the global population 40 years of age and older. Despite recent advancements in COPD treatment, a significant number of people continue to suffer and die from the disease.
The APG808 Phase 1 trial is designed as a double-blind, placebo-controlled, first-in-human, single-ascending dose trial in healthy volunteers. The study will evaluate the safety, tolerability and pharmacokinetics (PK) of APG808 and is expected to enroll approximately 32 healthy adults into four cohorts. Apogee expects interim data from the trial in the second half of 2024, and, pending positive results from the Phase 1 trial and following the submission of an IND or foreign equivalent, plans to initiate a potential Phase 1b trial in asthma with a data readout in the first half of 2025 and a randomized, placebo-controlled Phase 2 clinical trial in patients with moderate-to-severe COPD in 2025.
“By targeting known biologic drivers of disease and utilizing advanced antibody engineering such as improved half-life, Apogee aims to overcome limitations of existing therapies for I&I diseases,” said Carl Dambkowski, M.D., Chief Medical Officer of Apogee. “We demonstrated the potential benefits of optimizing antibody properties with APG777 and now hope to do the same with APG808, which, in head-to-head preclinical studies, demonstrated similar potency to current therapies but with a significantly longer half-life. Importantly, this points to potentially less frequent dosing for patients with COPD, which could significantly improve quality of life.”
About APG808
APG808 is a novel, subcutaneous extended half-life monoclonal targeting IL-4Rα, a target with clinical validation across eight Type 2 allergic diseases, for the potential treatment of chronic obstructive pulmonary disease (COPD), asthma and other inflammatory and immunology indications. APG808 has similar binding and femtomolar affinity for IL-4Rα as compared to a first generation mAb, DUPIXENT, and has demonstrated similar inhibition to DUPIXENT across three in vitro assays which measure downstream functional inhibition of the IL-13/IL-4 pathway (pSTAT6 induction, inhibition of TF-1 proliferation, and inhibition of TARC secretion). COPD is a progressive respiratory disease that is estimated to affect approximately 10 percent of the global population 40 years of age and older. Despite recent advancements in COPD treatment, a significant number of people continue to suffer and die from the disease. A Phase 1 clinical trial of APG808 in healthy volunteers is ongoing, and the company expects interim safety and pharmacokinetic data in the second half of 2024. Pending data from the Phase 1 trial, the company plans to initiate a potential Phase 1b trial in asthma with a data readout in in the first half of 2025 and a randomized, placebo-controlled Phase 2 clinical trial in patients with moderate-to-severe COPD in 2025.
About Apogee
Apogee Therapeutics is a clinical-stage biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis (AD), chronic obstructive pulmonary disease (COPD), asthma and other inflammatory and immunology indications with high unmet need. Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. The company’s two most advanced programs are APG777 and APG808, which are being initially developed for the treatment of AD and COPD, respectively. Based on a broad pipeline and depth of expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. For more information, please visit www.apogeetherapeutics.com.
SOURCE: Apogee Therapeutics
Post Views: 385
