Arcutis Biotherapeutics: Interesting, But Needs Cautious Approach Here

Summary

• Arcutis has an upcoming phase 3 data readout catalyst in 1Q 2021.
• Past data has been good, with a clear competitive difference.
• However, low cash and competition makes this a cautious investment, albeit with potential for high rewards.
• Looking for more investing ideas like this one? Get them exclusively at The Total Pharma Tracker. Get started today »

Arcutis Biotherapeutics Inc (NASDAQ:ARQT) has a phase 3 data readout for lead candidate ARQ-151 in plaque psoriasis in the first quarter of 2021. Plaque psoriasis is a chronic immune condition where red, scaly patches appear on the skin. This is the most common form of psoriasis. There are no cures. Topical therapies are the standards of care for the indication, however they suffer from either low efficacy or high adverse reaction problems. Roflumilast is an approved molecule for other, related diseases, but since it's oral, it's systemic, and thus has a poor safety profile. ARQ-151 is a topical form of roflumilast, which retains most of its efficacy especially for a skin condition, while removing much of its adverse effects. In trials, ARQ-151 has shown a better safety profile than its nearest competitor. This is a multi-billion dollar market with an unmet need. That's the story in a nutshell.

Catalyst

The nearest catalyst is the phase 3 data readout in 1Q 2021. The rest of its pipeline looks like this:

Source

Trial data

The following is an extensive quote from their trial data announcement.

Design: ARQ-151-201 (Phase 2b Study) - The most recent study completed with ARQ-151 in plaque psoriasis was a multi-center, multi-national, double-blind, vehicle-controlled Phase 2b study, in which 331 adults with plaque psoriasis covering between 2% and 20% BSA were randomized to receive 12 weeks of: (1) ARQ-151 0.3% topical cream, (2) ARQ-151 0.15% topical cream, or (3) matching vehicle. At the end of the 12-week treatment period, patients were eligible to roll over into our ARQ-151-202 open label extension study for an additional 52 weeks. Completion rates for the study were 93.6% in the ARQ-151 0.3% arm, 92.0% in the ARQ-151 0.15% arm, and 78.9% in the vehicle arm.

Efficacy: The primary efficacy endpoint of our Phase

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