Apogee Therapeutics' Atopic Dermatitis Potential: Strong Tolerability and Extended Half-Life in Early Trial

Apogee Therapeutics, Inc. (Nasdaq: APGE) has announced positive interim Phase 1 results from its first-in-human trial of APG990, a novel half-life extended OX40L antibody. The trial demonstrated an approximately 60-day half-life for APG990, supporting the potential for every three- and six-month maintenance dosing. This extended half-life, combined with the well-tolerated safety profile, positions APG990 as a promising candidate for the treatment of atopic dermatitis (AD).



The APG990 Phase 1 trial was a double-blind, placebo-controlled, single-ascending dose trial evaluating the safety, tolerability, and pharmacokinetics (PK) of APG990 in 40 healthy adult participants. Key results include:

* APG990 demonstrated a potential best-in-class PK profile, including a half-life of approximately 60 days, supporting the potential for every three- and six-month maintenance dosing.
* The PK profile supports the potential for a single 2 mL coformulated injection of APG279 (APG777 + APG990) administered every three and six months.
* APG990 was well tolerated across all five cohorts, with doses up to 1,200mg.
* The most common (≥10%) treatment-emergent adverse events (TEAEs) were headache.
* 53% of participants observed at least one TEAE.
* There were no Grade 3 TEAEs related to the study drug or severe adverse events.
* No adverse events led to study discontinuation.
* There have been no cases of pyrexia or chills.



The extended half-life of APG990, combined with its broad inhibition of Type 1, Type 2, and Type 3 inflammation, offers several potential benefits for patients with atopic dermatitis:

1. Improved patient compliance: Less frequent dosing can make it easier for patients to incorporate the treatment into their daily lives, leading to better adherence and, ultimately, improved treatment outcomes.
2. Enhanced clinical outcomes: By addressing multiple inflammation pathways, APG990 may provide better control of symptoms and improve overall clinical outcomes compared to existing treatments.
3. Minimizing side effects: The potential for improved clinical outcomes with APG990 may also lead to a reduction in side effects seen with other available therapies.



In conclusion, the positive interim Phase 1 results for APG990 demonstrate the potential for an extended half-life and strong tolerability in the treatment of atopic dermatitis. With a planned head-to-head Phase 1b trial of APG279 (APG777 + APG990) against Sanofi SA SNY / Regeneron Pharmaceuticals Inc’s REGN Dupixent (dupilumab) in 2025, Apogee Therapeutics is poised to make a significant impact on the atopic dermatitis treatment landscape. As the company continues to advance its pipeline, investors should keep a close eye on the progress of APG990 and its potential to revolutionize the treatment of atopic dermatitis.