Amgen pumps up rare disease drugs, but obesity is top of mind for some analysts
23 Feb 2024
Phase 3Phase 2Clinical ResultAcquisition
Amgen hosted an investor event focused on its rare disease portfolio Thursday, but while Mizuho analysts found details from the meeting to be "only incrementally positive," they believe obesity – where the company recently gave an early glimpse at its AMG 133 candidate – "is still the more important story for 2024."
AMG 133, also known as maridebart cafraglutide, is a bispecific molecule that activates GLP-1 and inhibits GIP. Earlier this month, results from a small, early-stage study published in Nature Metabolism showed that patients given a monthly injection of the drug lost up to 14.5% of their body weight in 12 weeks. Some people kept the weight off for up to 150 days after stopping the drug.
The company's presentation instead focused on a pair of rare disease therapies – Tepezza (teprotumumab) for thyroid eye disease and Krystexxa (pegloticase) for gout – that it acquired through its $27.8-billion takeout of Horizon Therapeutics, while also spotlighting some clinical-stage pipeline assets.
Expanding Tepezza internationally seem important for Amgen's growth, Mizuho analysts noted. In the US, reaching patients with low clinical activity scores and developing a subcutaneous form of the drug, where a pivotal Phase III programme is set to get underway in the first half, are expected to help it grow. Outside the country, Amgen said Japan and Europe are high-priority markets, with plans to file for approval in Europe in the first half of 2024 and to launch in Japan in 2025.
Plenty of room for more uptake
According to Barclays analysts, Amgen struck an overall positive tone by highlighting the "high level [of] addressable patients" across its rare disease portfolio. The company estimates there are about 100,000 potential patients in the US who could benefit from Tepezza, but only a small percentage of them are using it at the moment. A similar story plays out for Krystexxa; although there are over 100,000 potential patients, Amgen pegs current uptake at only around 6000.
It also emphasised three other programmes it expects will be key growth drivers – the CD40 ligand antagonist dazodalibep which recently entered Phase III for Sjögren's disease; the anti-ILT7 lupus candidate daxdilimab, and the LPA1 antagonist fipaxalparant. Amgen currently has a pair of Phase II studies evaluating fipaxalparant for idiopathic pulmonary fibrosis and systemic sclerosis. A readout from the first of these studies is due in the second half.
Barclays noted that the company wouldn't discuss differentiation against Bristol Myers Squibb's own LPA1 drug obexelimab, but "highlighted the unmet need and confidence in the mechanism." Obexelimab, which simultaneously binds CD19 and FcγRIIb, is currently in Phase III for IgG4-related disease. Bristol Myers Squibb acquired regional rights to the drug from Zenas BioPharma for $50 million upfront last year.
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