Allakos (ALLK) will discontinue further development of AK006

Allakos Inc. (Company) (Nasdaq: ALLK), today announced topline results from its phase 1 clinical trial of AK006 in chronic spontaneous urticaria (CSU).

“While AK006 was well tolerated, we are disappointed that the preclinical inhibitory effects observed did not translate to clinical benefit in patients with CSU. As a result, the Company has decided to discontinue further clinical development of AK006,” said Chin Lee, M.D, M.P.H., Chief Medical Officer of Allakos. “We express our gratitude to all of the patients, clinical trial investigators, and site coordinators in these trials.”

Phase 1 Cohort of AK006 in Patients with Chronic Spontaneous Urticaria

In the CSU cohort, 34 adult patients with moderate-to-severe CSU refractory to antihistamines with or without prior exposure to omalizumab were enrolled and randomized 2:1 to receive 720 mg of intravenous AK006 (n=23) or placebo (n=11) once every four weeks (Q4W). Eight of the 34 patients had previously received omalizumab (5 randomized to AK006, 3 randomized to placebo). The primary endpoint of the proof-of-concept cohort was safety and tolerability with therapeutic activity explored using the Urticaria Activity Score (UAS)-7 at 14 weeks.

Exploratory Efficacy Results

Safety Results

AK006 was well-tolerated with a favorable safety profile. There were no serious adverse events (SAEs) in subjects on AK006. Adverse events occurring in 2 or more subjects on AK006 were headache (2), infusion related reaction (2), and Covid-19 (2) vs. 1, 0, and 0, respectively, on placebo, all of which were mild-to-moderate in severity.

Restructuring Activities & Planned Actions

• The Company plans to discontinue AK006-related activities across clinical, manufacturing, research and administrative functions and reduce its workforce by approximately 75%.
• The Company plans to retain approximately 15 employees to explore strategic alternatives, maintain compliance with regulatory and financial reporting requirements, and wind-down the phase 1 clinical trial.

Cash Guidance
The Company ended the fourth quarter of 2024 with approximately $81 million in cash, cash equivalents, and investments (unaudited).

The Company estimates that cash used in restructuring activities to closeout AK006 development, including severance and contractual payments to vendors, will be approximately $34 million to $38 million. The Company also estimates that a significant majority of these restructuring costs will be paid over the first and second quarters of 2025.

The Company estimates it will have cash, cash equivalents and investments in a range of approximately $35 million to $40 million at June 30, 2025.

Conference Call and Webcast Information

The webcast and conference call will take place at 8:30 am ET / 5:30 am PT on January 27^th, 2025. Please click here to pre-register to participate in the conference call and obtain your dial in number and PIN.

A webcast of the live call will be available online in the investor relations section of the Allakos website here. Access to the webcast replay will be available approximately two hours after completion of the call and will be archived on the Company’s website for approximately 30 days.

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