INmune (INMB) Announces Positive Data for its AD Candidate
INmune Bio (INMB) announces positive data for its AD candidate, XPro, from an early stage study. Shares are up in pre-market.
Clinical-stage immunology company INmune Bio, Inc. INMB recently announced positive data for its lead Alzheimer’s disease (AD) candidate XPro (pegipanermin), its selective DN-TNF inhibitor. Shares jumped in premarket trading following the same.
Xpro (formerly Xpro1595) is a next-generation inhibitor of tumor necrosis factor (TNF) that uses a dominant-negative TNF technology that is very different from the approved TNF inhibitors that block the effects of both soluble and trans-membrane TNF.
The biomarker data from the analysis of the company’s recently concluded phase I study of XPro in Alzheimer’s patients showed that the candidate decreases multiple species of Phospho Tau (pTau). It also improves neuroimaging biomarkers of myelination in patients with AD.
XPro treatment showed a statistically significant decrease in phospho Tau 217 (pT271) and pT181, and an improvement in an imaging biomarker of myelination. The patients treated with 1.0 mg/kg of XPro once a week for three months showed a 46% reduction in CSF pT217 and a lesser reduction in pT181.
Per the company, while pT181 is recognized as the standard CSF biomarker of AD, recent studies suggest that pT217 has higher discriminative accuracy for AD and a stronger correlation with amyloidosis and cognitive decline.
In addition, improvement in white matter MRI metrics, including a 16% rise in radial diffusivity, a biomarker of remyelination was also reported. The company had earlier reported improvements in apparent fiber density (axonal integrity), and free water (neuroinflammation). In each metric, improvements continued throughout the 12-month extension trial (the last time point assessed).
INmune plans to start enrolling a blinded, randomized phase II study in patients with mild AD by the end of 2021. The six-month trial will enroll 200 patients at centers across North America and Australia. Patients will receive 1mg/kg of XPro weekly by subcutaneous injection. The primary endpoint is EMACC (Early AD/Mild Cognitive Impairment Alzheimer's Cognitive Composite), a sensitive measure of cognitive function.
Shares of the company have gained 38.6% in the year so far compared with the industry’s growth of 1.9%.
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The AD space promises significant potential but developing drugs for the same is quite complex and challenging. The FDA approval of Biogen’s BIIB AD drug, Aduhelm, has put the spotlight on AD drugs/candidates. In June 2021, Biogen and partner Eisai won the FDA approval for Aduhelm (aducanumab-avwa) as the first and only AD treatment, after a few setbacks.
Quite a few companies are striving hard to get their AD drugs approved. Among the companies developing drugs for the same is Prothena PRTA. Its pipeline candidate PRX005 is being evaluated for the treatment of AD. The candidate is being developed as part of the global neuroscience research and development collaboration with Bristol Myers Squibb.
Eli Lilly and Company LLY is also developing donanemab, an investigational antibody therapy for AD. In June, the FDA granted Breakthrough Therapy designation to donanemab for AD.
INmune currently has a Zacks Rank #3 (Hold). INmune Bio currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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