Apogee Therapeutics' APG990 Demonstrates Extended Half-Life and Favorable Tolerability in Interim Phase 1 Data

Apogee Therapeutics has announced today positive interim results from its phase 1 trial of APG990, a novel subcutaneous monoclonal antibody targeting OX40L in atopic dermatitis (AD).¹

The study revealed a half-life of approximately 60 days and a favorable tolerability profile, supporting potential maintenance dosing every 3 to 6 months.

Image Credit: © Ольга Тернавская - stock.adobe.com

The double-blind, placebo-controlled, single-ascending dose trial enrolled 40 healthy adult participants across 5 cohorts, with doses up to 1,200 mg. APG990 was well tolerated, with headache being the most common treatment-emergent adverse event. Importantly, no severe adverse events or study discontinuations occurred.

APG990's extended half-life and favorable safety profile suggest it could be a valuable addition to AD therapies, according to Carl Dambkowski, MD, chief medical officer of Apogee.

"Today’s results are highly encouraging, further validating our approach to create fully optimized antibodies with the potential to improve patients’ lives," Dambkowsi said in a news release.¹ "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."

Apogee plans to coformulate APG990 with APG777, an IL-13 inhibitor, to create APG279. This combination aims to provide deep type 2 inhibition alongside broad type 1-3 inhibition, potentially enhancing clinical outcomes. Preclinical studies have shown enhanced pharmacologic responses with this combination, and no safety concerns were observed at any dose level.

Based on these findings, Apogee plans to submit an Investigational New Drug application for APG279 and initiate a phase 1b trial comparing APG279 to dupilumab (Dupixent; Regeneron and Sanofi) in patients with moderate to severe AD. This trial is expected to begin this year, with results anticipated in the second half of 2026.

"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," said Michael Henderson, MD, chief executive officer of Apogee.¹ "APG279 could offer patients a more effective treatment option, while minimizing side effects seen with other available therapies."

Reference

1. 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). News release. Apogee Therapeutics. March 3, 2025. Accessed March 3, 2025. https://investors.apogeetherapeutics.com/news-releases/news-release-details/apogee-therapeutics-announces-positive-interim-phase-1-results