The US Food and Drug Administration (FDA) has notified Florida-based INmune Bio that its Phase II clinical trial investigating XPro (Xpro1595; pegipanermin) in Alzheimer’s disease will remain on full clinical hold in the US.

The agency has also requested additional information on the long-term potency of the therapy. The request followed the company’s recent submission to the FDA, which showed a possible increase in the long-term potency of Xpro.

The news led to a decline in Inmune’s stock price, which was down by over 14% in premarket trading on 19 December, compared to the market close on the previous day.

The FDA first put the Phase II trial (NCT05318976) on clinical hold due to manufacturing issues in May 2022. The company has since shifted plans to add international sites to the trial. Last month, INmune Bio obtained approval for a clinical trial application (CTA) to launch a Phase II clinical trial of XPro in Poland, with plans to add two to six more countries in the EU.

INmune added that it “will provide clarification to the FDA in a response before the end of the year that it believes will resolve the remaining questions.”

INmune’s CEO RJ Tesi said: “The hold will not impact our progress in completing the Phase II Alzheimer’s study on schedule, as our patient recruitment projections are solely reliant on sites outside of the US.”

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XPro is a tumour necrosis factor (TNF) inhibitor which aims to reduce neuroinflammation to stop or slow the progression of cognitive and psychiatric symptoms of Alzheimer’s. The drug is being evaluated as a treatment for Alzheimer’s in a placebo-controlled Phase II trial.

The trial will enrol an estimated 201 participants with mild Alzheimer’s with biomarkers of inflammation, as per The Phase II trial results are expected by the end of 2024, as per a 1 November press release.

Another therapy in INmune’s pipeline includes a natural killer (NK) cell immunotherapy, which primes patient’s NK cells to eliminate minimal residual disease in patients with cancer. In May, the company received clearance from the FDA to start a Phase I/II trial in patients with metastatic castration-resistant prostate cancer.