Today, BioArctic reported Q3 results, which included an update on the continuing clinical studies of BAN2401 and ABBV-0805, with Eisai and AbbVie, respectively.
During the quarter, BioArctic had net revenues of SEK 10m, operating profit was SEK -20.7m and earnings per share SEK -0.23. The cashflow from operating activities was SEK -9.4m. Operating expenses for Q3 amounted to SEK 32m (SEK 136m for the nine-month period), lower than last year due to decreased activity in the Parkinson’s program.
The loss for the year so far was SEK -55m, and cashflow from operating activities was SEK -65.6m. Cash and cash equivalents amounted to SEK 1,036m.
Q3 has offered a string of positive news on the clinical development of BioArctic’s main compounds, BAN2401 and ABBV-0804, as well as on the rest of the pipeline: progress on the blood-brain barrier technology and diagnostic tools. An interesting new project in pre-clinical stage is the AD1801, addressing the ApoE, the most common genetic risk factor for Alzheimer’s.
Despite being delayed due to the covid-19 crisis, Eisai has continued with this BAN2401 study in a responsible way towards the patients. Eisai expects the study to be fully enrolled until the end of the year and expects results in 2022. The study is for patients with mild cognitive impairment due to Alzheimer’s disease.
AHEAD 3-45, new phase III study for BAN2401
During the quarter, Eisai initiated a new phase III study with BAN2401, with focus on prevention: AHEAD 3-45. The AHEAD Study is the first Alzheimer’s disease prevention trial to enroll patients as young as 55 years old, in order to test whether BAN2401 slows the earliest brain changes (memory loss) associated with Alzheimer’s disease.
Study participants are enrolled in one of two AHEAD trials based on whether they have intermediate or elevated levels of amyloid in their brain:
Over the course of the study, the two different trial groups will receive intravenous (IV) infusions of BAN2401 or a placebo, an inactive substance designed to mimic the appearance of the drug. The infusion process takes approximately 60 minutes.
At different points in the study, participants have a PET scan (or Positron Emission Tomography brain scan), to look at amyloid and tau (another protein) in the brain. This is expected to be the first study of its kind to use PET scans to measure amyloid and tau in all participants. The PET scan takes pictures of participants’ brains, allowing researchers to see and track changes in amyloid and tau levels.
Results from this study are expected in H2 2027.
Presentation on the OLE study of BAN2401
At the end of July at the digital AAIC congress, Eisai presented also the latest data from the phase 2b open-label extension (OLE) study of BAN2401. The preliminary results showed that the effects of BAN2401 were sustained and levels of amyloid in the brain measured at three, six and twelve months with BAN2401 treatment decreased in those patients who had previously received placebo. The incidence of amyloid-related imaging abnormalities-edema (ARIA-E) remained low during BAN2401 treatment to date in the open-label extension study and is comparable to the Phase 2b study. The reason for the mild side effects in the form of ARIA-E could potentially be the very well-designed profile of the anti-body, specifically targeting toxic forms of amyloid-beta accumulation – protofibrils/oligomers – as opposed to monomers or fibrils.
During the quarter, BioArctic’s partner AbbVie decided to stop recruitment into the second part of the Phase 1 study of ABBV-0805 in Parkinson’s disease patients and to accelerate the drug candidate into phase 2 proof of concept study.
Based on all these positive developments, both clinical and in the research pipeline, and most importantly, BioArctic’s sustained capacity to innovate and deliver high quality products, we maintain our valuation of SEK 150 per share and see the company as greatly undervalued.
We are looking forward to the upcoming CTAD week Nov 4-7 includes five presentations on BAN2401.
On November 6th at 10am FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will discuss biologics license application (BLA) 761178, for aducanumab solution for intravenous infusion, submitted by Biogen Inc., for the treatment of Alzheimer’s disease.
Either way, the results of this meeting should not be overinterpreted in relation to BAN2401, which was developed differently, has a different design and binding profile than aducanumab, namely binding much more strongly to toxic both small and large protofibrils. Aducanumab has a weaker binding profile specifically to those toxic forms of amyloid beta. This stronger binding profile might explain the better clinical profile of BAN2401 – low ARIA-E (only in 1 in 10 patients and of those only 10% symptomatic), no need for titration and clinical end point benefit already at 6 months.
We will be watching closely these events, but whether the clinical data on aducanumab should be sufficient for registration or no, should not affect our perception of BioArctic’s compound.
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