INmune Bio Provides Update on Two Patients From Phase 1b Alzheimer’s Disease Trial Who Continue to Receive XPro Under Compassionate Use for Over 3 Years

INmune Bio Inc. recently shared an update on two patients from the Phase 1b trial completed in 2021 who have continued to receive XPro for treatment of Alzheimer’s Disease (AD) for more than 3 years under the Australian compassionate use program known as the Special Access Scheme (SAS).

Both patients, herein referred to as “Patient 1” and “Patient 2,” was an original study participant in the Phase 1b clinical trial (ClinicalTrials.gov ID NCT03943264), in the target dose 1mg/kg cohort, which commenced in November of 2019 and completed in September of 2021.

In contrast to clinical trials, patients in the SAS receive exclusive care from their primary care physicians, with the Company’s involvement limited to supplying XPro. Reports from the primary care physicians indicate that XPro has been well-tolerated throughout the treatment period, with stable cognitive function observed in the patients. Furthermore, the patients express a desire to continue receiving XPro for Alzheimer’s disease treatment.

Patient 1 was diagnosed with AD at age 61 and enrolled in the Phase 1b clinical trial in December 2019 at age 63. Patient 1 completed the 3-month Phase 1b open label trial and opted to enroll in the 12-month open label extension. After completion of the open label extension, Patient 1 continued to receive XPro under the SAS. The primary care physician treating Patient 1 under the SAS has indicated “[Patient 1] has suffered no obvious adverse reactions to XPro. His general physical state is unchanged. I believe that his mental cognitive state has also been stable with the use of XPro. His family members are keen to continue the management with XPro if available as they believe there is stability with the treatment.”

Patient 2 was diagnosed with AD at age 59 and enrolled in the Phase 1b clinical trial in December 2019 at age 60. Patient 2 completed the 3-month Phase 1b open label trial and opted to enroll in the 12-month open label extension. After completion of the open label extension, Patient 2 continued to receive XPro under the SAS. The primary care physician treating Patient 2 under the SAS has indicated “[Patient 2’s] cognitive decline has stopped, and he continues to do well.”

A video with a patient sharing their experience in the Phase 1 clinical trial, the open-label extension trial, and the Australian SAS can be found by clicking here. Additionally, the principal investigator who treated both patients previously commented on their response to XPro as part of a webinar given by the company describing the results of the AD01 Phase 1b trial in 2022 by clicking here (at 6:50 min mark).

“We are delighted to report that according to primary care physicians treating these patients under the SAS, the long-term administration of XPro has been safe and well-tolerated with these patients maintaining stable cognitive functions for more than 3 years of continued XPro treatment,” said R.J. Tesi, MD, CEO of INmune Bio. “Given the typical progression of Alzheimer’s Disease and comparative data from other drug trials, stable cognitive and physical function over this long period is encouraging.”

The company remains on track in alignment with prior guidance for completing the current Phase 2 clinical trial investigating XPro for treatment of AD in patients with biomarkers of inflammation.

INmune Bio Inc. is a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has two product platforms that are both in clinical trials: The Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver of many diseases. DN-TNF product candidates are being investigated to determine if they can treat cancer (INB03), Early Alzheimer’s disease, and treatment-resistant depression (XPro). The Natural Killer Cell Priming Platform includes INKmune developed to prime a patient’s NK cells to eliminate minimal residual disease in patients with cancer. INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic and solid tumor malignancies, and chronic inflammation. For more information, visit www.inmunebio.com.