In a client update on Thursday, Mackie Research analyst André Uddin has changed his rating for biotech company Promis Neurosciences (Promis Neurosciences Stock Quote, Chart TSX:PMN) from “Sell” to “Under Review,” claiming that Promis’s continued funding for its lead drug candidate is a waste of investor money.
Last week, news broke that a joint Phase III trial from American biotech company Biogen and Japanese pharma company Eisai on anti-amyloid beta antibody aducanumab in patients with mild Alzheimer’s had been discontinued due to a futility analysis conducted by an independent data monitoring committee.
The result puts all drug trials focused on amyloid beta as entirely suspect, says Uddin, including Promis’ own PMN310, still more than a year away from clinical trials.
“Pharmaceutical and biotech companies have spent billions on developing beta-amyloid drug candidates – everything failed. We believe it is a waste of investor money to continue funding PMN310 given that Biogen/Eisai’s aducanumab Phase 3 trial failed – as this drug candidate partially targeted the oligomers of beta amyloid,” stated Uddin.
“Let’s be optimistic and think PMN310 (targeting toxic oligomers of beta amyloid) makes it to the end of Phase II with positive results. In our opinion, it will be extremely difficult to find a pharmaceutical/biotech partner for this asset or even to find an investor to fund the Phase 3 program. Why do we think it will be so difficult to find a future partner? There has been a 100 per cent Phase III historical failure rate for all beta amyloid drug candidates, despite showing promising earlier clinical data,” he says.
Uddin supports his position with comments from Dr. Rudolf Tanzi, a world leader in Alzheimer’s research, and US competitor Geoffrey Porges at Leerink, both of whom are sceptical about any future research conducted on amyloid beta.
Last week, Promis released a statement in response to the Biogen failure, arguing that PMN310 takes a different approach from that of aducanumab and therefore shouldn’t be lumped in with the latter’s fate.
“Aducanumab was developed over a decade ago to go after plaque, which we have since learned is the incorrect therapeutic target because plaque is a largely non-toxic form of amyloid beta,” stated Dr. James Kupiec, Promis’ Chief Medical Officer. “Aducanumab wasted too much limited ammunition on the wrong target, which also led to the dose limiting side effect of brain swelling (edema). Unlike aducanumab, Promis’ lead antibody candidate for Alzheimer’s, PMN310, reflects key lessons learned, namely that the toxic oligomer of amyloid beta is a root cause of AD, not plaque.”
“PMN310 is the first antibody to selectively target just the toxic oligomer, a misfolded, toxic form of amyloid beta, offering a potential significant advantage over aducanumab and other less selective antibodies in terms of both efficacy and safety,” he states