A Phase 1b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of APG777 in Adults With Mild-to-Moderate Asthma

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and immunogenicity of APG777 in adult participants with mild-to-moderate asthma.
The duration of the study will be approximately 52 weeks (364 days) for each participant and will consist of a Screening Period, Treatment Period, and Follow-up Period.

Start Date27 Mar 2025

Sponsor / Collaborator

Apogee Therapeutics, Inc.

NCT06395948

/ RecruitingPhase 2

A Two-part, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of APG777 in Patients With Moderate-to-severe Atopic Dermatitis

This is a two-part study that will evaluate the safety and efficacy of APG777 in participants with moderate-to-severe Atopic Dermatitis (AD). Part A (Proof-of-concept) and Part B (Dose-regimen Finding) will evaluate the safety and efficacy of various induction and maintenance dose regimens of APG777 compared to placebo. The study duration for any individual participant will be up to 106 weeks which includes: screening, induction, maintenance, and post-treatment follow-up periods. Participants randomized in Part A are not permitted to participate in Part B.

Start Date29 Apr 2024

Sponsor / Collaborator

Apogee Therapeutics, Inc.

ACTRN12623000786695

/ CompletedPhase 1

A Phase 1, Randomized, Blinded, Placebo-Controlled, Single and Multiple Dose, First-in-human Study of the Safety, Tolerability, and Pharmacokinetics of APG777 in Healthy Participants

Start Date31 Jul 2023

Sponsor / Collaborator

Apogee Therapeutics, Inc.

100 Clinical Results associated with APG-777

100 Translational Medicine associated with APG-777

100 Patents (Medical) associated with APG-777

Literatures (Medical) associated with APG-777

01 Sep 2024·Dermatology and Therapy

Extended Half-life Antibodies: A Narrative Review of a New Approach in the Management of Atopic Dermatitis

Review

Author: Yilmaz, Orhan ; Torres, Tiago

Atopic dermatitis (AD) is a chronic, inflammatory skin disease characterized by intense pruritus and eczematous lesions, significantly impacting physical health and quality of life. The pathogenesis of AD involves genetic predisposition, immune dysregulation, and environmental factors, with a defective skin barrier playing a crucial role. Treatment options for AD include both topical and systemic therapies, with advanced treatments like Janus kinase inhibitors and biologics offering significant improvements but facing limitations in safety and dosing frequency. Extended half-life antibodies represent a promising advancement for the management of immune-mediated inflammatory diseases, including AD. These antibodies, engineered for prolonged circulation and reduced dosing frequency, target key cytokines and immune pathways known to be involved in the pathogenesis of AD, offering potential for less frequent administration while maintaining efficacy. Currently, two such agents are in phase 2 trials. APG777, targeting interleukin-13 (IL-13), and IMG-007, targeting OX40 receptor, have shown promising preclinical and early clinical results. They demonstrated prolonged half-lives and the potential for less frequent dosage regimen, along with significant improvements in AD symptoms. These therapies could enhance patient adherence and reduce healthcare burdens by decreasing injection frequencies and clinic visits. As research continues, extended half-life antibodies could significantly improve AD management and patient quality of life. Further studies will determine the long-term safety and efficacy of extended half-life antibodies, with ongoing innovations in antibody engineering likely to broaden their applications and benefits.

News (Medical) associated with APG-777

03 Mar 2025

·pipelinereview.com

Apogee Therapeutics Announces Positive Interim Phase 1 Results from the APG990 Healthy Volunteer Trial, Unlocking Potential Maintenance Dosing Every Three and Six Months for APG279 (APG777 + APG990)

Interim Phase 1 results for APG990, a novel half-life extended OX40L antibody, exceeded trial objectives and demonstrated an approximately 60-day half-life APG279 (APG777 + APG990) Phase 1b head-to-head study vs. DUPIXENT supported by successful completion of preclinical combination toxicology studies and positive APG990 interim Phase 1 results; trial planned to initiate this year with readout expected in second half of 2026 SAN FRANCISCO, CA and BOSTON, MA, USAI March 03, 2025 I Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest inflammatory and immunology (I&I) markets, including for the treatment of atopic dermatitis (AD), asthma, eosinophilic esophagitis (EoE), chronic obstructive pulmonary disease (COPD) and other I&I indications, today announced positive interim Phase 1 results from its first-in-human trial of APG990. APG990 interim Phase 1 pharmacokinetic (PK) data showed a half-life of approximately 60 days across doses tested. These PK data support the possibility of every three- and six-month maintenance dosing of APG990 with as little as 50 mg, which when considered with APG279 (APG777 + APG990) coformulation data, provides the potential for dosing the combination two to four times per year with a single 2 mL coformulated injection. The combination also offers the potential for improved clinical outcomes by addressing the heterogeneity of AD given preclinical data demonstrating deep Type 2 inhibition from APG777 and broad Type 1-3 inhibition from APG990. “We’re pleased to report findings from our third clinical program today, APG990, which demonstrated extended PK and a favorable tolerability profile, supporting its potential as a first-in-class combination with APG777 for the treatment of AD and other inflammatory diseases that could address multiple inflammation pathways,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “The interim results as well as the supportive preclinical combination toxicology studies are an important step forward in our combination plans for the program, suggesting strong potential for compatibility with APG777 and supporting our planned APG777 and APG990 coformulated combination approach, which we have named APG279. With the potential to broadly inhibit Type 1, Type 2 and Type 3 inflammation, APG279 could offer patients a more effective treatment option, while minimizing side effects seen with other available therapies. Based on these findings, we plan to initiate a head-to-head Phase 1b trial of the combination against DUPIXENT this year.” APG990 is a novel, subcutaneous (SQ), half-life-extended monoclonal antibody (mAb) that targets OX40L, which is positioned further upstream in the inflammatory pathway than IL-13, allowing for a broader impact on the inflammatory cascade by inhibiting Type 1, Type 2, and Type 3 pathways. Apogee’s approach of coformulating two extended half-life mAbs, APG279, holds the potential for best-in-class dosing and efficacy across AD and broader I&I diseases. The APG990 Phase 1 clinical trial is a double-blind, placebo-controlled, first-in-human, single-ascending dose trial evaluating the safety, tolerability and PK of APG990 in 40 healthy adult participants. Key results include: In addition, preclinical studies of the combination of APG777 and APG990 showed potential for enhanced pharmacologic responses relative to individual agents, and exhibited no safety findings at any dose level, including the highest dose tested of 150 mg/kg per agent in a 3-month combination toxicology study. “Today’s results are highly encouraging, further validating our approach to create fully optimized antibodies with the potential to improve patients’ lives. With good tolerability at doses up to 1,200mg and a half-life of approximately 60 days, APG990 demonstrated the potential for quarterly or less frequent dosing and was supportive of it as a combination partner with APG777. Looking ahead to our planned combination approach, we continue to believe that APG990’s broad inhibition across Type 1, 2, and 3 inflammation, coupled with APG777’s deep and sustained inhibition of Type 2 inflammation, could potentially result in a safe and effective treatment option for people living with atopic dermatitis and other inflammatory diseases,” said Carl Dambkowski, M.D., Chief Medical Officer of Apogee. “We would like to extend our gratitude to the participants, investigators, and site staff whose partnership made this study a success, driving progress toward innovative I&I treatments for patients in need.” Based on these results, the company plans on submitting an Investigational New Drug application or foreign equivalent for APG279. Following clearance, the company plans to initiate a Phase 1b clinical trial in moderate-to-severe AD of APG279 against DUPIXENT in 2025, with data expected in the second half of 2026. Webcast Details Apogee Therapeutics’ live webcast of the APG990 interim Phase 1 results will begin today at 8:30 a.m. ET. The live webcast can be accessed via this link or the Investors section on the Company’s website at https://investors.apogeetherapeutics.com/news-events/events . A replay of the webcast will be available following the call. About APG990 APG990 is a novel, SQ, half-life extended mAb targeting OX40L, initially being developed for AD. OX40L is located further upstream in the inflammatory pathway than IL-13 or IL-4Rα and targeting it could potentially have broader impact on the inflammatory cascade by inhibiting Type 1, Type 2 and Type 3 pathways. AD is a heterogeneous disease and varies by age, severity and ethnicity. With current approved biologics in AD only targeting the type 2 inflammatory pathway, OX40L could represent another therapeutic option for patients, especially the portion of patients who do not benefit from currently available treatments. In our head-to-head preclinical assays, APG990 has demonstrated similar or improved potency to amlitelimab. In addition, based on our interim Phase 1 APG990 studies, we believe APG990 can be dosed every three- and six- months in maintenance, which, if our clinical trials are successful, would represent a significant improvement compared to first generation OX40L antibodies that are expected to be dosed every four to twelve weeks. The company plans to develop APG279 (APG777 and APG990), together as a potential first-in-class combination for the treatment of AD and other I&I diseases by combining deep and sustained inhibition of Type 2 inflammation via APG777’s inhibition of IL-13 with broader inhibition of Type 1-3 inflammation through APG990’s inhibition of OX40L. About Apogee Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of AD, asthma, EoE, COPD and other I&I indications. 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. APG777, the company’s most advanced program, is being initially developed for the treatment of AD, which is the largest and one of the least penetrated I&I markets. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. 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 https://apogeetherapeutics.com . SOURCE: Apogee Therapeutics

Phase 1Clinical ResultIND

10 Dec 2024

·pipelinereview.com

Apogee Therapeutics Announces First Participants Dosed in Phase 1 Clinical Trial of APG333, its Novel Half-Life Extended TSLP Antibody for the Treatment of Respiratory and Broader I&I Conditions

Interim safety and pharmacokinetic data from Phase 1 healthy volunteers trial anticipated in 2H 2025 APG777 + APG333 can potentially address key drivers of respiratory diseases more broadly versus monotherapy Preclinical proof-of-concept achieved for APG777 + APG333 combination with clinical trial planning underway in asthma and COPD SAN FRANCISCO, CA and WALTHAM, MA, USA I December 10, 2024 I Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest inflammatory and immunology (I&I) markets, including for the treatment of atopic dermatitis (AD), asthma, chronic obstructive pulmonary disease (COPD), eosinophilic esophagitis (EoE) and other I&I indications, today announced that it has initiated dosing of healthy volunteers in its clinical trial of APG333, a novel, subcutaneous (SQ) half-life extended monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), which is being evaluated initially as a treatment for people living with asthma, COPD and broader I&I conditions. “The initiation of the APG333 Phase 1 clinical trial marks our fourth program to enter clinical trials in less than 18 months and represents an important step in our pipeline evolution, as we continue to establish the building blocks for our combination strategy,” said Carl Dambkowski, M.D., Chief Medical Officer of Apogee. “TSLP is a clinically validated target that plays an important role in both Type 2 and Type 3 inflammation, the primary drivers of inflammatory respiratory conditions. Based on its mechanism, it has the potential to broadly address obstructive respiratory diseases, including for the approximately half of patients with low Type 2 inflammatory respiratory diseases who currently have fewer treatment options. We plan to initially explore APG333 for the treatment of asthma, with the ultimate goal of leveraging this investigational therapy in combination with APG777, a combination approach that could optimally address respiratory and broader I&I diseases.” The APG333 Phase 1 clinical 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 APG333 and is expected to enroll approximately 32 healthy adults into 4 cohorts. Apogee expects interim data from the trial in the second half of 2025. In preclinical studies, the combination of APG777 + APG333 has been shown to drive broader and deeper inhibition of inflammation centrally with deeper impact on local airway responses compared to approved or in-development biologics, with the potential for a significantly less frequent dosing schedule. About APG333 APG333 is a novel, SQ extended half-life mAb targeting TSLP, a key driver of Type 2 and Type 3 inflammation in eosinophilic and non-eosinophilic conditions. TSLP is an epithelial cell-derived cytokine that has emerged as an attractive validated target for the treatment of I&I indications. In addition, a TSLP-targeting mAb may be used in combination with other mAbs for potentially greater efficacy in broader populations. TSLP inhibition has been clinically validated, with one approved product on the market for the treatment of severe asthma without biomarker or phenotype restrictions. About Apogee Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of AD, asthma, COPD, EoE and other I&I indications. 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. APG777, the company’s most advanced program, is being initially developed for the treatment of AD, which is the largest and one of the least penetrated I&I markets. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. 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 https://apogeetherapeutics.com . SOURCE: Apogee Therapeutics

Phase 1Immunotherapy

07 Dec 2024

·endpts.com

Lilly beats Novo in weight loss; Apogee plots Dupixent challenge; Biosecure compromise coming?; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here . We have a group of reporters — myself included — in San Diego this weekend to cover all the latest from this year’s ASH conference. Can’t make it? Sign up for our virtual ASH event on Tuesday recapping some of the biggest headlines. — Max Gelman Lilly beats Novo in first head-to-head weight loss study Eli Lilly said its weight loss drug Zepbound bested Novo Nordisk’s rival Wegovy in a Phase 3 head-to-head trial, providing the clearest evidence yet that it may have an edge over its competitor. Lilly launched the randomized, controlled trial, SURMOUNT-5, more than a year and a half ago in April 2023. On Wednesday, the company said patients given Zepbound lost 20.2% of their body weight on average by week 72, compared to 13.7% for Wegovy. Apogee plots Dupixent head-to-head In other head-to-head news, I&I drugmaker Apogee plans to pit its lead drug APG777 against Sanofi and Regeneron’s blockbuster Dupixent in a trial starting next year. APG777 will be paired in a co-formulation with Apogee’s OX40L-targeting mAb called APG990 for patients with moderate-to-severe atopic dermatitis. The company thinks APG777, an IL-13 targeting monoclonal antibody, can eventually generate more than $10 billion in sales. “Everyone says, ‘Oh, we’re going to be better. It should be better,’” CEO Michael Henderson said. “No one ever actually runs that head-to-head study.” Biosecure compromise in the works? Lawmakers are considering a compromise to the Biosecure Act that would add an executive branch review to the process, giving the White House or federal agencies final say on the enactment of restrictions. A version of the bill previously passed by the House of Representatives would directly force biopharmas to eventually cut ties with Chinese companies named in the legislation. However, the situation appears to be highly fluid, proposals may change further and any potential deal could fall apart in Congress’ rush to finish its work before the session ends. Novartis pays $1B upfront for Huntington’s drug In its latest deal, Novartis has agreed to pay $1 billion upfront for PTC Therapeutics’ Phase 2 Huntington’s drug and “related molecules.” The deal could be worth another $1.9 billion in biobucks, the companies announced on Monday. Novartis was previously working on its own Huntington’s disease medicine, but ended the Phase 2 program last year due to neurotoxicity signals. Healthcare execs weigh security risks after United Healthcare shooting The shooting of United Healthcare CEO Brian Thompson has prompted other healthcare companies to rethink the measures they take to keep their top brass safe. CEOs often have protective details, and there have been prior cases of top executives who have faced harassment and threats. But this week’s shooting was an outlier, and actual violence against top executives is almost unheard of. It’s also put a spotlight on security measures for next month’s JP Morgan Healthcare Conference — the biggest pharma event of the year. SPOTLIGHT As 23andMe struggles, another genetic testing company bets on drug discovery Eliav Barr defends Merck’s LaNova deal, but cautions VEGF bispecifics have yet to deliver mature data Lilly continues to expand its empire of GLP-1 factories with new $3B buildout MORE IN DEALS MORE IN R&D MORE IN MANUFACTURING MORE IN FINANCING MORE IN PHARMA MORE IN FDA+ MORE IN HEALTH TECH

Phase 3Phase 2

100 Deals associated with APG-777

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Moderate Atopic Dermatitis	Phase 2	United States	Apogee Therapeutics, Inc.	29 Apr 2024
Moderate Atopic Dermatitis	Phase 2	Canada	Apogee Therapeutics, Inc.	29 Apr 2024
Moderate Atopic Dermatitis	Phase 2	Poland	Apogee Therapeutics, Inc.	29 Apr 2024
Severe Atopic Dermatitis	Phase 2	United States	Apogee Therapeutics, Inc.	29 Apr 2024
Severe Atopic Dermatitis	Phase 2	Canada	Apogee Therapeutics, Inc.	29 Apr 2024
Severe Atopic Dermatitis	Phase 2	Poland	Apogee Therapeutics, Inc.	29 Apr 2024
Asthma	Phase 1	United States	Apogee Therapeutics, Inc.	27 Mar 2025
Asthma	Phase 1	United Kingdom	Apogee Therapeutics, Inc.	27 Mar 2025
Dermatitis, Atopic	Phase 1	-	Apogee Therapeutics, Inc.	07 Aug 2023
Eosinophilic Esophagitis	Preclinical	United States	Apogee Therapeutics, Inc.	01 Dec 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ACTRN12623000786695 (GlobeNewswire) Manual	Phase 1	-	40	APG777	jmforaqxho(wahhreqwgj) = ioelrfuhog kgvfcxmipo (sqigggztjx ) View more	Positive	05 Mar 2024
				placebo	-
NCT06395948 (APG777, EADV2023)	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis IL-13	-	APG777	rokxjppznt(jxxpxnlmfk) = djmvaalwxj xyuwjwwbpq (zmpclgtpas )	Positive	11 Oct 2023
				Lebrikizumab	rokxjppznt(jxxpxnlmfk) = jvsgsfrfnj xyuwjwwbpq (zmpclgtpas )

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