Skip to content

Allakos: The biomarker worked. The scientific communication failed.

Picture of Yoanne Clovis, PhD

Allakos had every standard department. Four years and four trial failures later, none of it had been enough. What most Phase II/III biotechs mistake for infrastructure, and what infrastructure actually is.

 

What Allakos already had

By the time the December 2021 Phase 3 readout landed, Allakos employed 192 people, 132 of them in R&D[1]. The Chief Medical Officer led combined Clinical Development and Medical Affairs. A Vice President of Medical Affairs Strategy and Informatics reported into the function[1]. The standard mid-stage biotech departments were in place.

None of it stopped what happened next.

December 21, 2021

Both pivotal trials missed their symptomatic co-primary endpoints. Phase 3 ENIGMA-2 in eosinophilic gastritis and duodenitis. Phase 2/3 KRYPTOS in eosinophilic esophagitis[2]. The biomarker effect was overwhelming in both. Eosinophil counts dropped 80 to 90 percent versus placebo. Symptoms did not separate.

The mechanism worked. The hypothesis for the trial wasn't validated.

CEO Robert Alexander's statement in the December 21, 2021 release described the company as:

"[...] deeply disappointed that the studies did not achieve their symptomatic endpoints"[3] - Robert Alexander, CEO | December 21, 2021

In the same release, the company announced that development would proceed in atopic dermatitis (already underway), and that the company planned to initiate chronic spontaneous urticaria and asthma studies in 2022[2].

The data had just shown that the hypothesis behind lirentelimab's Siglec-8 mechanism did not produce the symptom benefit the trials were designed to demonstrate. The communication, deployed inside the same press release, committed the same molecule and the same hypothesis to three additional disease populations.

Three years and three failures later

ATLAS in atopic dermatitis failed in 2024. MAVERICK in chronic spontaneous urticaria failed in 2024[4]. The company pivoted to AK006, an anti-Siglec-6 antibody. Different receptor. Different cell type. The same underlying hypothesis: inhibit a receptor on an immune effector cell, expect downstream symptom benefit. AK006 failed in January 2025.

CMO Chin Lee's statement in the January 27, 2025 release described the company as:

"[...] disappointed that the preclinical inhibitory effects observed did not translate to clinical benefit"[5] - Chin Lee, CMO | January 27, 2025

Different executive. Different molecule. Disappointed. Did not translate. Effects observed but not clinical benefit. The framing template was the same.

Three years and three additional trial failures separated this statement from the December 2021 one. The communications had carried the same hypothesis forward as if the four trials between them had not happened. Allakos was delisted from Nasdaq in May 2025[6].

What was structurally missing

In a clinical-stage biotech, the scientific position and the public communications that depend on it are two sides of the same coin. The scientific position is the content of every regulatory submission, partner conversation, medical affairs document, and investor call. When the position doesn't update, the communications can't update either, because the position is the content.

Allakos had the departments. What it didn't have was the connective tissue between them. No mechanism to integrate the four functions' reads of the same data into a single defensible position. No governance to update that position when the field's evidence shifted. No readiness to deploy a coordinated answer when a readout forced the question.

That is scientific coordination infrastructure. It is a distinct organizational capability from any of the standard departments. Having a CMO does not mean having it. Having Medical Affairs does not mean having it. Having 192 people across the standard functions does not mean having it.

The version of this failure you're more likely to live

Most Phase 2/3 biotechs will not live the Allakos version, where a single scientific hypothesis stays locked in across three and a half years of trial failures. They will live a quieter version. Four functions, each holding a defensible read of the same data, none concealing anything, none coordinated.

The Allakos version closes the gap across years. The cross-functional version closes it across hours: at the advisory board, the partner meeting, the FDA Type B, the Series C pitch.

Same structural failure. Same fix.

The working definition

Coordination risk is the gap between what your team holds internally and what your company can say consistently across functions when the data becomes public. The fix is not another department. It is the infrastructure that connects the ones you already have.

 

Sources

All sources verified live as of May 2026. Headcount and organizational data drawn from Allakos's SEC filings for fiscal year 2021.

  1. Allakos Inc. Form 10-K for fiscal year ended December 31, 2021. Documents 192 full-time employees as of December 31, 2021, with 132 in R&D. Form 10-K also documents the executive role structure described. SEC EDGAR filings
  2. Allakos Inc. press release. "Allakos Announces Topline Phase 3 Data from the ENIGMA 2 Study and Phase 2/3 Data from the KRYPTOS Study in Patients with Eosinophilic Gastrointestinal Diseases." December 21, 2021. globenewswire.com
  3. Nasdaq. "Allakos Reveals Topline Results from ENIGMA 2 & KRYPTOS Studies; Shares Crash." Contains direct quote from CEO Robert Alexander on the December 21, 2021 readout. nasdaq.com
  4. Allakos Inc. quarterly disclosures and BioSpace coverage of the ATLAS and MAVERICK Phase 2 results, 2023 to 2024. librariesforthefuture.bio
  5. Allakos Inc. press release. "Allakos Announces Topline Results from its Phase 1 Trial of AK006 in Patients with Chronic Spontaneous Urticaria and Announces Restructuring." January 27, 2025. Contains direct quote from CMO Chin Lee. globenewswire.com
  6. Investing.com. "Allakos completes merger with Concentra Biosciences." May 15, 2025. investing.com

 

 

Where this shows up for you

The cross-functional version of this is detectable before the readout exposes it.
A 3-minute self-assessment names where the gap currently sits in your team's interpretation of your Phase 2 data. Designed for CEOs, CSOs, CMOs, and Heads of Medical Affairs at Phase 2/3 pre-commercial biotechs.

 
,