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April 19, 2022

Amgen’s Phase III trial of ABP 654 meets primary efficacy endpoint

The trial assessed the safety and efficacy of ABP 654 versus Stelara in adults with moderate to severe plaque psoriasis.

Amgen has reported that the Phase III clinical trial of its ABP 654 in adults with moderate to severe plaque psoriasis met the primary efficacy endpoint. 

The company is developing ABP 654 as a biosimilar candidate to Stelara (ustekinumab).

An approved human interleukin-12 and interleukin-23 antagonist, Stelara is intended to treat moderate to severe plaque psoriasis in adults and paediatric patients aged six years or above who have received phototherapy or systemic therapy, as well as active psoriatic arthritis in adults. 

It is also indicated to treat moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis in adults. 

ABP 654 has the same dosage strength, pharmaceutical form, administration route and dosing regimen as ustekinumab, which is licensed in the US and approved in the European Union (EU).

The multicentre, randomised, double-blinded, comparative trial assessed the safety and efficacy of ABP 654 versus Stelara in adult moderate to severe plaque psoriasis patients. 

The trial enrolled 563 subjects who were categorised to receive either ABP 654 or ustekinumab.

According to the initial data, the trial met the primary efficacy endpoint, showing no clinically meaningful differences between ABP 654 and Stelara.

The primary assessment analysed the percentage improvement of psoriasis area severity index (PASI) from baseline to week 12, which demonstrated a mean difference of 0.14 between ABP 654 and Stelara and was found to be within the prespecified margins. 

Furthermore, the safety profile of ABP 654 was in line with Stelara.

Amgen Research and Development executive vice-president David Reese said: “Amgen remains committed to providing patients who live with inflammatory diseases access to high-quality biosimilar medicines. 

“We look forward to continuing to expand our inflammation portfolio to offer patients a variety of treatment options.”

A serious, chronic inflammatory ailment, psoriasis leads to raised, red, scaly patches on the skin.

The company currently has 11 biosimilars in its portfolio, with five approved by the US Food and Drug Administration (FDA) and three approved for use in the EU.

The latest development comes after Amgen reported long-term efficacy and safety data from the Phase I/II CodeBreaK 100 trial of Lumakras (sotorasib) in KRAS G12C-mutated advanced non-small cell lung cancer patients.

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