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Probiodrug (PBD-NA): Positive read-across from BAN2401 Phase II data
13-Jul-2018 / 10:27 GMT/BST
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*Probiodrug (PBD-NA): Positive read-across from BAN2401 Phase II data*
*Recommendation: OUTPERFORM*
*Target Price: EUR71.00*
*Current Price: EUR3.91 (COB on 12th July 2018)*
*KEY TAKEAWAY*
Eisai / Biogen recently reported positive top-line data for the 856-patient
Phase II trial Study 201 for the anti-amyloid beta ("Abeta") protofibril mAb
BAN2401 in early Alzheimer's disease ("AD"). This is the first time a
late-stage trial in AD shows disease-modifying effects with regard to both
Abeta reduction in the brain and an improvement of clinical function.
Importantly, the data supports the Abeta hypothesis for AD therapy and is a
much-needed development following a string of late-stage failures. This is
good news for Probiodrug, whose lead asset PQ912 has a unique mechanism of
action that inhibits the formation of toxic products of Abeta without
interfering with important physiological processes. We understand that
Probiodrug is exploring multiple options to finance the PQ912 Phase IIb trial
that is expected to start enrolling patients in Q4/2018E. We maintain our
OUTPERFORM recommendation.
*Phase II trial for BAN2401 shows statistically significant efficacy at 18
months*
In December 2017, Biogen / Eisai had reported that Study 201 did not meet the
primary endpoint at 12 months using Bayesian analysis designed to move BAN2401
into Phase III more rapidly. However, in a remarkable turn of events, on 5th
July the development partners announced that the study did show statistically
significant ("s.s.") slowing of disease progression at 18 months for the
highest treatment dose (10mg/kg biweekly) on the key clinical endpoint ADCOMS
- which combines elements of the more traditional ADAS-Cog, MMSE and CDR-SB -
when using conventional statistical analysis, and that this had also been the
case at 6 and 12 months. Results of amyloid PET analysis were also s.s. at
this time-point, thus reflecting a reduction of Abeta in the brain. There were
no unexpected safety findings. The results of the trial will be presented in
an oral session at the Alzheimer's Association International Conference
("AAIC") in Chicago on 25th July.
*Data provides much-needed support for the beta amyloid hypothesis...*
In addition to being positive news for Eisai, Biogen and BioArctic (the
Swedish biotech company that discovered BAN2401), the data strongly supports
the amyloid hypothesis as a valid target for the development of
disease-modifying AD therapies. This is a welcome development for patients,
industry and investors following a string of high-profile, late-stage failures
in the AD space (particularly with regard to beta- and gamma-secretase
inhibitors designed to block the production of Abeta) and indicates that
soluble Abeta aggregates seem to be a key toxic culprit.
*...and is good news for Probiodrug's PQ912 in Phase IIb development*
There is also positive read-across for Probiodrug, whose lead asset PQ912, a
small molecule glutaminyl cyclase ("QC") inhibitor, has a unique mechanism of
action, as it inhibits the formation of synaptotoxic soluble aggregates /
oligomers of Abeta without impacting physiological processes. The compound
showed encouraging efficacy in a Phase IIa trial in early-stage AD patients.
The Phase IIb programme includes two trials (1x Europe, 1x US) that will focus
on cognition and function (activity of daily living) through the assessment of
neuropsychological and functional endpoints, and assess the pathophysiological
changes that characterise early AD through the measurement of changes in the
EEG as well as a set of biomarkers. Both trials incorporate new draft guidance
provided by EMA and FDA for early AD trials and could lead to conditional
approval in 2023E.
*All options on the table regarding financing of Phase IIb trial*
In light of the positive BAN2401 data and the concomitant validation of the
Abeta hypothesis, we would expect renewed interest from big pharma with regard
to Abeta-targeting assets and hence continue to believe that a licensing deal
in H2/2018E is possible, as reflected in our forecasts. That said, we
understand that Probiodrug is exploring multiple financing options including a
licensing deal, with all options currently on the table. New CEO Ulrich Dauer
is a seasoned biotech entrepreneur and we are therefore confident in his
execution ability.
Kind regards,
Brigitte de Lima, PhD, CFA | Analyst
goetzpartners Healthcare Research Team | Research Team
goetzpartners securities Limited
The Stanley Building, 7 Pancras Square, London, N1C 4AG, England, UK.
T +44 (0) 203 859 7725 | healthcareresearch@goetzpartners.com /
brigitte.delima@goetzpartners.com
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704431 13-Jul-2018
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July 13, 2018 05:27 ET (09:27 GMT)
