ProMIS Neurosciences Inc.'s (PMN:TSX; ARFXF:OTCQB) lead therapeutic candidate for Alzheimer's disease, PMN310, will be evaluated in a Phase 1b clinical trial in early 2023, Argus Research analyst Steve Silver reported in a June 27 report. PMN310 is a monoclonal antibody that binds with high affinity and selectivity to toxic oligomers of amyloid-beta, a recognized root cause of Alzheimer's disease.
"We estimate that more than 100 candidates for Alzheimer's disease are currently in the clinic and view PMN310 as potentially representing a best-in-class opportunity," Silver wrote.
The upcoming Phase 1b study, Silver relayed, will be open-label and dose ascending. Safety and efficacy will be assessed. The trial will be conducted at five to eight sites, allowing for quick enrollment.
To move forward with the Phase 1b study, ProMIS has been preparing to file an investigational new drug application for PMN310. As part of that, among other efforts, high-concentration formulations of the antibody, which can support subcutaneous dosing, are being developed. That work is expected to be finished soon.
ProMIS has a competitive edge with PMN310 and its scientific platform, Silver highlighted.
With the latter, the company can develop selective antibody therapies against toxic oligomers that result from misfolded proteins associated with the development and progression of certain neurodegenerative diseases.
"ProMIS' approach is validated and differentiated from other treatments and technologies in development due to its accuracy of computational modeling and artificial intelligence that enable the generation of therapeutic antibodies that are highly selective for toxic misfolded proteins and not their normal, physiological forms," Silver wrote.
"Importantly, the company’s platform can be applied across multiple degenerative diseases with a common protein misfolding pathogenesis, including Parkinson’s Disease (PD), Multiple System Atrophy (MSA), in addition to its more advanced efforts in Alzheimer’s and ALS," the analyst noted.
With a focus on neurodegenerative diseases, ProMIS "operates in an extremely attractive market that is among the largest areas of unmet needs across the entire biopharmaceutical industry," the analyst noted. "To date, neurodegenerative diseases have seen few novel drug approvals, and those approved have provided little more than symptom management or modestly slowed disease progression, rather than significantly impacting the underlying cause of the disease."
Silver noted that beyond PMN310, the biotech firm is developing PMN267 as its lead product candidate for the treatment of amyotrophic lateral sclerosis (ALS). Findings so far are encouraging, the analyst noted.
"To date, an intrabody version of PMN267, delivered inside cells via a gene therapy vector, has shown significant reductions in the amount of TDP-43 aggregates in human motor neurons derived from ALS patients, and an injectable antibody treatment has produced promising trends for protection against disability," Silver explained.
Looking forward, Silver expects ProMIS to continue executing its development strategy. Also, it may uplist its U.S. stock to the NASDAQ and capitalize on opportunities to partner with a large pharmaceutical company on any of its product candidates.
"Over the longer-term, we see its growing pipeline providing optionality for additional partnering activities. We think its product candidates as well as broad platform discovery capabilities are likely to attract the interest of a Big Pharma industry that is holding its highest level of cash and M&A capabilities in industry history," the analyst noted.
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