Apogee Therapeutics Initiates Dosing of APG333 in Phase 1 Clinical Trial

Apogee Therapeutics, Inc. recently announced the initiation of dosing of healthy volunteers in its clinical trial for APG333, a subcutaneous half-life extended monoclonal antibody targeting thymic stromal lymphopoietin. The trial is primarily focused on evaluating APG333 as a potential treatment for individuals living with asthma, chronic obstructive pulmonary disease (COPD), and broader inflammatory and immunology (I&I) conditions.

This Phase 1 clinical trial for APG333 is designed as a double-blind, placebo-controlled study involving the administration of single-ascending doses in healthy volunteers. Approximately 32 healthy adults are expected to be enrolled in four cohorts, with interim data anticipated to be available in the latter half of 2025.

Apart from the current trial, Apogee has shared plans for a combination strategy involving APG777 and APG333, which has shown promising results in preclinical studies. The combination of these two compounds is aimed at providing a more comprehensive and effective approach to addressing respiratory diseases compared to single-agent therapies currently under development or in circulation.

According to Carl Dambkowski, M.D., Chief Medical Officer of Apogee Therapeutics, “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.”

While outlining future prospects, the company remains cautiously optimistic, emphasizing the importance of safety, tolerability, and pharmacokinetics assessments within the context of the current trial. Moreover, Apogee underlines the significance of leveraging investigational therapies like APG333 in combination with other compounds to maximize therapeutic outcomes in patients with respiratory and broader I&I diseases.

Cautionary statements within the filing highlight that forward-looking statements contained within should be approached with careful consideration due to the inherent uncertainties and risks involved. These risks and uncertainties extend beyond the company’s control and are subject to change. Apogee underscores the importance of regulatory compliance and ongoing assessments in ensuring the safety and efficacy of its investigational products.

For more detailed information regarding the trial and the company’s pipeline, interested parties can refer to the official press release furnished by Apogee Therapeutics.

Investor Contact:
Noel Kurdi
VP, Investor Relations
Apogee Therapeutics, Inc.
[email protected]

Media Contact:
Dan Budwick
1AB
[email protected]

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Apogee Therapeutics’s 8K filing here.

About Apogee Therapeutics

Apogee Therapeutics, Inc, through its subsidiary, operates as a biotechnology company that develops biologics for the treatment of atopic dermatitis (AD), asthma, chronic obstructive pulmonary disease (COPD), and related inflammatory and immunology indications. The company primarily develops APG777, a subcutaneous (SQ) extended half-life monoclonal antibody (mAb) for AD; and APG808, an SQ extended half-life mAb for COPD.