INmune Bio Inc. has announced that the U.S. Food and Drug Administration has granted Fast Track designation to XPro™ (pegipanermin) for the treatment of early Alzheimer’s disease.

The designation covers patients with mild cognitive impairment linked to Alzheimer’s disease as well as those with mild Alzheimer’s dementia. The company stated that the decision supports development of the therapy for a growing patient population affected by the condition.

Fast Track designation is intended to speed up the development and review of treatments for serious diseases that address unmet medical needs. The status allows closer communication with the FDA and may provide eligibility for Rolling Review and other accelerated regulatory pathways.

XPro™ is a selective soluble tumour necrosis factor (sTNF) inhibitor designed to target neuroinflammation linked to Alzheimer’s disease progression. The therapy aims to block harmful inflammatory activity while preserving immune functions involved in brain protection and repair.

According to the company, inflammation in the brain is increasingly recognised as an early factor contributing to cognitive decline in Alzheimer’s disease, while currently approved therapies do not directly target these inflammatory pathways.

INmune Bio stated that results from the Phase 2 MINDFuL study, along with discussions with the FDA following the trial, supported the Fast Track designation. The company plans to advance XPro™ into a Phase 2b/3 registrational programme focused on patients with signs of inflammation linked to disease progression.

The company added that its patient selection strategy aims to identify individuals at higher risk of near-term cognitive decline in order to improve study efficiency and treatment evaluation.

The growing number of people affected by neurodegenerative diseases continues to present a major public health challenge. Data from the Alzheimer’s Association estimates that 7.4 million Americans aged 65 and older are living with Alzheimer’s dementia, while around 15 million people are experiencing mild cognitive impairment, which is often considered an early stage before dementia develops.

 

Source: globenewswire.com

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