I-Mab is set to commence the Phase I clinical trial of an experimental drug, Protollin, to treat patients with Alzheimer’s disease.

The US Food and Drug Administration (FDA) cleared the company’s investigational new drug (IND) application to conduct the trial.

A novel immunotherapy, Protollin is designed to trigger the innate immune system to stimulate a response against the beta-amyloid protein plaque aggregation and ensuing tau tangles that lead to memory loss.

I-Mab noted that the planning for the trial is currently progressing.

The study will evaluate the immunotherapy’s ability to trigger the immune system to remove beta-amyloid protein plaques linked to Alzheimer’s disease.

I-Mab founder, chairman and director Dr Jingwu Zang said: “Advancing Protollin into clinic is a critical milestone in the search to develop novel therapies for this devastating disease, and we are honoured to be engaging in a planning process with partners around the globe and contributing our expertise.”

I-Mab and Nhwa received worldwide exclusive licences from Brigham and Women’s Hospital and Inspirevax (earlier known as Biodextris) to develop, produce and market Protollin.

Biodextris will produce and deliver Protollin required for preclinical studies, as well as clinical trials until the first subject in the Phase Ib MAD study is enrolled.

I-Mab will develop and sell Protollin in markets outside Greater China.

Meanwhile, Nhwa will develop and market the drug in mainland China, Hong Kong, Macau and Taiwan regions.

According to preclinical data, Protollin could potentially modify immune cells and treat disorders with an immune component.

Furthermore, delivery via nasal spray could aid the drug to reach the brain and induce the anticipated immune response, the company noted.

The preliminary results favour the drug’s use for treating neurodegenerative diseases, including Alzheimer’s disease.

In a separate development, the US FDA accepted KeifeRx’s IND application to begin the Phase III NILEAD trial of its drug, Nilotinib BE, to treat Alzheimer’s disease.

The primary goals of the trial are to study the safety and efficacy of the drug on dementia progression in early Alzheimer’s disease.