Reaching its Apogee? Inside One of Biotech’s Most Interesting Emerging Stories

Reaching its Apogee?

Apogee Therapeutics is a US biotech aiming to challenge Sanofi/Regeneron’s Dupilumab (Dupixent). Dupixent generated sales of US$17.8bn in 2025 across several inflammatory disease indications, including Atopic Dermatitis (AD).

Apogee has been in the Fund since it became a publicly listed company in July 2023 at US$17 per share. The company’s proposition was straightforward: develop antibodies targeting a well-validated mechanism of action, but with less frequent dosing through modification of the Fc region. This approach extends the antibodies’ serum half-life from dosing every 2–3 months to potentially every six months.

As an investor, one always wonders whether something is simply too straightforward — too good to be true. Why hadn’t Sanofi or Regeneron pursued this approach themselves as a lifecycle management strategy for Dupixent?

On the same day we met Apogee management for the first time as part of a TTW meeting, we also met with Sanofi.¹ Interestingly, Sanofi dismissed the concept of a long-acting Dupixent as commercially irrelevant. As a long-standing investor in drug development, I’ve learned that when large companies outright dismiss a biotech competitor’s approach, it often means they haven’t done their homework. The better approach is to discuss the competing data — even if early — because it at least demonstrates awareness of the emerging dataset.

This prompted me to dig deeper into the preclinical data for APG777 (now known as Zumilokibart) and speak with industry contacts about their views on a long-acting Dupixent. The concept of long-acting antibodies reducing injection burden for patients immediately resonated with me. The preclinical pharmacokinetic data suggested Apogee’s approach had genuine potential, while the clinical development plan and timeline also pointed to rapid progress.

A clinical trial in healthy volunteers was scheduled to begin in the second half of 2023 (in Australia), with data expected in mid-2024 to determine whether the long-acting thesis translated into humans. That would be the first key milestone, with efficacy data in AD patients expected from 2025 onwards.

At the time, my concerns were twofold.

First, how best to manage the placebo effect in trials. With dermatological conditions, it’s critical to ensure patients genuinely have the condition being studied; otherwise, placebo responses can appear artificially high. Through discussions with the Apogee team and key opinion leaders in the field, these concerns were put into perspective. I saw that Apogee was controlling placebo risk through stringent recruitment criteria to ensure patients did indeed have Atopic Dermatitis.

The second concern was the competitive landscape, including emerging oral therapies. Competition is always a key consideration for any company.

The company’s IPO valuation was reasonable. The Apogee team appeared level-headed, and the shareholder register included high-quality investors. There was also a developing pipeline behind the lead asset, suggesting Apogee could ultimately build a comprehensive portfolio over time.

Soon after the IPO, the company announced the commencement of its Phase I healthy volunteer trial, and Mark McKenna was appointed Chairman. We knew Mark through our investment in Prometheus Biosciences — a successful IPO investment we made in March 2021. Mark has an exceptional commercial and operational mind.

With the data available at the time — and with Mark joining the company — we became increasingly convinced of the opportunity ahead for Apogee.

Since the IPO, Apogee has made significant progress. First, by confirming that less frequent dosing is feasible through sustained serum drug levels over time. More recently, positive data in AD patients demonstrated deepening responses across multiple endpoints from week 16 through to week 52 using both 3-month and 6-month dosing intervals.

This appears differentiated versus Dupixent and may reflect near-complete neutralisation of IL-13. In addition, Zumilokibart demonstrated rapid itch relief — an area where Dupixent has historically been slower to respond.

There is more data still to come this year, which should help refine the optimal dosing regimen and ultimately inform the Phase III clinical trial design. These studies are commercially important because they may allow physicians to individualise treatment once approved.

So far, the Zumilokibart hypothesis is playing out for Apogee and, as one broker put it, the company is on track to “give all current therapies a run for their money.”

Beyond Zumilokibart, Apogee is also advancing additional pipeline assets featuring optimised backbones and co-formulations.

In summary, preclinical data initially piqued our interest, discussions with industry experts helped frame the opportunity, and management gave us confidence in the company’s capabilities and execution plan. Over time, the emerging clinical data has strengthened both our understanding and the investment case.

That’s how it’s supposed to work — although it doesn’t always.