Apogee Therapeutics – Positive Phase 1 Data for APG808 Indicating Long Half-Life and Potential Dosing Flexibility

The press release from Apogee Therapeutics, Inc. highlights significant progress and the potential of novel biologic programs for inflammatory and immunology (I&I) diseases. The company presented positive interim phase 1 data for its drug APG808, indicating it was well-tolerated with a half-life of approximately 55 days, supporting the potential for 2* to 3-month dosing and demonstrating deep and sustained inhibition of biomarkers.

Additionally, the company provided data up to 12 months for APG777, showing a 77-day half-life and potential path to annual dosing. The topline data from the APG777 phase 2 part A trial in atopic dermatitis (AD) has been accelerated to mid-2025 based on strong enrollment.

Apogee also achieved preclinical and coformulation proof-of-concept for the combination of APG777 and APG990, with a phase 1b head-to-head trial against Dupixent expected to initiate in 2025, and data in the second half of 2026.

For APG777 and APG333 combination in asthma and chronic obstructive pulmonary disease (COPD), preclinical proof-of-concept has been achieved, with clinical trial planning underway.

The company's CEO, Michael Henderson, emphasized the potential of APG777 to disrupt the AD market, with data suggesting potential dosing as infrequently as once per year. This innovation has garnered positive feedback from patients, physicians, and payers.

The press release also outlined the company's plans to advance the development of APG777 in asthma and eosinophilic esophagitis (EOE), as well as its first-in-class combination approach to AD by targeting types 1-3 inflammation.

Apogee is also planning to take a combination approach to the treatment of asthma and COPD with the combination of APG777 and APG333, aiming for enhanced efficacy and extended dosing regimens.

The market has reacted to these announcements by moving the company's shares 1.5% to a price of $45.82. Check out the company's full 8-K submission here.

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