Apogee rises as long-acting eczema drug heads for phase 3
Apogee's chief executive Michael Henderson.
Positive mid-stage results with Apogee Therapeutics' IL-13 inhibitor APG777 in atopic dermatitis have driven the company's shares up around 20%, as it prepares for a phase 3 programme.
The 16-week data from Part A of the APEX study in people with moderate-to-severe AD showed that APG777 exceeded Apogee's expectations, with a 71% decrease from baseline in the Eczema Area and Severity Index (EASI) from baseline compared to 33.8% with placebo.
Moreover, two-thirds (66.9%) of patients treated with the IL-13 inhibitor achieved a 75% improvement on the scale (EASI-75), versus 24.6% of the control group, which the company claimed is "the highest EASI-75 response rate […] for any biologic in a global study to date."
Now, the stage is set for the readout of Part B of the trial later this year in the maintenance setting and a phase 3 programme that is due to kick off in 2026, according to the San Francisco and Boston-based biotech, which completed an initial public offering two years ago, raising around $300 million.
The treatment of moderate-to-severe AD has been revolutionised by new treatments, particularly Sanofi and Regeneron's IL-4 and IL-13 inhibitor Dupixent (dupilumab), which dominates the biologic segment of the market.
Other recent entrants in the increasingly crowded market include Galderma's Nemluvio (nemolizumab), Almirall's Ebglyss (lebrikizumab), and Leo Pharma's Adtralza (tralokinumab) – all IL-13 inhibitors – along with a clutch of oral JAK inhibitors including Eli Lilly's Olumiant (baricitinib), AbbVie's Rinvoq (upadacitinib), and Pfizer's Cibinqo (abrocitinib).
Apogee is pitching APG777 as a 'best-in-class' IL-13 inhibitor that could offer robust efficacy and less-frequent dosing than rivals, potentially requiring injections only every three or six months as a maintenance treatment, while market leader Dupixent, for example, needs to be given every two to four weeks.
"Today's results bring us closer to that vision, and we believe further de-risks APG777's path to approval," said the company's chief executive, Michael Henderson, who said the drug could "set a new standard of care […] benefitting patients, providers, and payers."
Apogee also said today that it has started dosing patients in a phase 1b head-to-head study pitting follow-up drug APG279, which targets IL-13 and OX40L, against Dupixent. The drug also has the potential to be dosed just two to four times a year.
Earlier this year, the company also reported phase 1b data with APG808, a long-acting IL-4-targeting antibody for asthma and other type 2 allergic diseases.
