INmune Bio
’s
INMB
stock price rose 12.2% on Wednesday after management announced that it has dosed the first patient in a phase II study with XPro1595 (XPro), its investigational candidate for Alzheimer’s disease (AD).
This phase II study will evaluate XPro, its next-generation tumor necrosis factor (TNF) inhibitor candidate, to treat cognition and function in patients with mild AD and biomarkers of inflammation. The duration for the treatment of patients in this study is 6 months.
The initiation of the study is based on data from the phase I study, which evaluated XPro in AD patients. Data from the phase I study demonstrated improvement in multiple biomarkers in AD pathology, including a reduction in neuroinflammation and neurodegeneration as well as an improvement in biomarkers of neurorepair and neuron communication.
XPro is designed to target neuroinflammation. Per management, a reduction in neuroinflammation in the brain has shown to improve cognitive function in AD patients.
INmune’s shares have declined 16.9% in the year so far compared with the
industry
’s 11.9% decrease.
Image Source: Zacks Investment Research
Patients who will complete the phase II study will also be invited to participate in an extension study, which will continue to monitor the biomarkers in inflammation as well as cognition for an additional period up to 12 months.
INMB also plans to start another phase II study in patients with mild cognitive impairment. Data from both these phase II studies is anticipated next year.
The FDA’s nod to
Biogen
’s
BIIB
Aduhelm in June 2021 has put the spotlight on AD since its controversial approval. Biogen’s Aduhelm had received an accelerated approval from the regulatory agency to treat patients with mild cognitive impairment or mild dementia due to AD.
Despite being the first medicine to be approved for reducing the clinical decline in AD indication and targeting the underlying cause of the disease, Biogen’s Aduhelm has had a slower-than-expected launch.
Aduhelm’s FDA approval faced a lot of criticism regarding its mixed efficacy results. The FDA approved Aduhelm despite an FDA advisory committee voting against its approval last year due to mixed outcomes from the ENGAGE and EMERGE studies.
The drug was initially launched with a hefty price tag of $56,000 a year, which was widely condemned. These issues seemingly affected demand, patient access and reimbursement for Aduhelm.
For 2021, Biogen recorded revenues of only $3 million from Aduhelm sales, which were lower than expected.
Zacks Rank & Stocks to Consider
INmune Bio currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector are
Assertio Holdings
ASRT
and
Collegium Pharmaceutical
COLL
, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see
the complete list of today’s Zacks #1 Rank stocks here
.
Assertio Holdings’ earnings per share estimates for 2022 have increased from 20 cents to 35 cents in the past 60 days. Shares of ASRT have rallied 42.2% in the year-to-date period.
Earnings of Assertio Holdings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 20.8%.
Collegium Pharmaceutical’s earnings per share estimates for 2022 have increased from $3.79 to $5.59 in the past 60 days. The same for 2023 has increased from $4.79 to $7.44 in the past 60 days. Shares of COLL have risen 4.4% year to date.
Earnings of Collegium Pharmaceutical missed estimates in three of the last four quarters and beat the mark on one occasion, the negative surprise being 57.6%, on average.
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