Biogen and Eisai's asset Lecanemab has a PDUFA date set for Friday 1/6/23
Lecanemab targets and effectively reduces beta-amyloid aggregates in the brain
Lecanemab showed a statistically significant reduced rate of decline in clinical signs of dementia (CDR-SB) and less brain bleeding and swelling than Biogen's previously approved ADUHELM, which was a commercial and PR disaster
There is current controversy about whether even with the reduced risk of bleeding and swelling, the risk is worth the modest decrease in dementia with Lecanemab
Numerous other clinical assets in development from other companies target different forms of beta-amyloid (See Table 1)
Many other exciting Alzheimer's readouts are expected in 2023!
Alzheimer's companies have been in the spotlight for years, but many have seen an even bigger popularity since September when Phase 3 data from Biogen and Eisai was reported. Biogen (BIIB) and Eisai (EASLY) are in partnership for the asset Lecanemab to treat Alzheimer's disease, and the product is possibly almost to market. Lecanemab (beta-amyloid target) has a PDUFA set for Jan 6, 2023 and multiple other companies have assets with the same mechanism of action. BIIB is up 38% since Sept 27 when Ph3 data was reported. ABOS's ACU193 (also an anti-beta-amyloid mAb) shot up 123% upon Eisai/BIIB data but unfortunately is down to only 12% above the Sept 27 price. This could be because ABOS's data was pushed from Q2 to Q4 2023 and/or as the market realized that ACU193 targets beta amyloid oligomers, which are quite a bit different than beta amyloid aggregates targeted by Lecanemab. PRTA is up over 90% since the Lecanemab phase 3 readout, and it has held that level. PRTA's PRX012 targets beta-amyloid mainly oligomers too. PRTA has a much deeper pipeline and set of collaborations than ABOS, which may explain why it has held the gain, or possibly the fact that it is a subQ formulation and possibly other attributes like dose might have played a role in the differences in stock price movement.
See Table 1 for other assets that target beta-amyloid.
Table 1. Alzheimer's disease assets targeting beta-amyloid
All Alzheimer's companies
There are many exciting Alzheimer's disease readouts coming in the next year, including several Phase 3 readouts. See Table 2 for all smid-cap biopharma Alzheimer's readouts including info on stage and readout dates, and see our forum for info on mechanisms of action.
Table 2. Upcoming smid-cap biopharma Alzheimer's readouts
The BLA for Eisai/Biogen's asset lecanemab was accepted in July but additional data wasn't reported until Sept 2022.
Lecanemab's submission was accepted and given priority review on 7/5/22. Will full approval be granted on the PDUFA date set at Jan 6, 2023? The accelerated approval pathway was accepted based on Ph 2 data. However, full CLARITY AD Phase 3 data wasn't reported until Sept 27, 2022. The BLA was submitted before CLARITY AD data was reported, but the FDA agreed that data could serve as the confirmatory study to verify clinical benefit - leading to the high stock jump upon reporting data. There was no AdComm for Lecanemab.
Phase 3 CLARITY AD primary efficacy data:
Primary endpoint met: "Lecanemab treatment met the primary endpoint and reduced clinical decline on the global cognitive and functional scale, CDR-SB, compared with placebo at 18 months by 27%, which represents a treatment difference in the score change of -0.45 (p=0.00005) in the analysis of Intent-to-treat (ITT) population" https://investors.biogen.com/news-releases/news-release-details/lecanemab-confirmatory-phase-3-clarity-ad-study-met-primary
The data presented later at CTAD 2022 (See our Biomed conference calendar and details for investors for future meetings) appears convincing that Lecanemab slows dementia in Alzheimer's patients (See FIGs. 1 and 2). And the reduction in amyloid plaques was dramatic, with plaque in patients on Lecanemab on average dropping to below the amyloid positivity level at 18 months. (See Azlforum.org CTAD data summary). Now the question is what happens after longer time on the therapeutic, which should be answered at least in part, by the open label extension study.
FIGs. 1 and 2 from "Dare We Say Consensus Achieved: Lecanemab Slows the Disease"
To see more information about the Lecanemab trial and how data compared to ADUHELM, see our full forum article.
Lecanemab vs. Aduhelm
Biogen had a previous AD asset - ADUHELM that was approved on June 7, 2021. However, clinical efficacy results were inconsistent, and there are issues with brain bleeding and swelling (Aria-E) in a relatively high (~35%) percent of patients. CMS (Medicare & Medicaid) restricted coverage of Aduhelm to only those people in clinical trials, so sales have been very low in the first year of launch. See more info on Aduhelm and Table 3 in our forum for additional data on how Lecanemab and ADUHELM compare, including commonality of side effects.
LLY's asset donanemab is also an anti-beta amyloid mAb. Donanemab targets a modified form of beta-amyloid - N3pG. In data reported 11/30/22, Donanemab showed reduction of brain amyloid plaque levels by 65.2% (Aduhelm showed reduction of just 17%). The Phase 3 TRAILBLAZER-ALZ 4 study met primary and secondary endpoints. Additional Ph3 data from two other TRAILBLAZER trials could also be reported in Q1 or mid year 2023.
A review of information regarding Alzheimer's clinical assets will be one of the highlights of this year's JP Morgan conference. See our JP Morgan 2022 post for details on the conference and presentation dates;/times. Here are some notable presentations:
BIIB will be presenting at JPM on Monday 1/9/23 at 11:15AM.
LLY will be presenting at JPM on Tuesday 1/10/23 at 3:45PM.
See our forum for more info on Alzheimer's companies - especially BIIB assets
This article is not investment, tax, or legal advice. Please do your own diligence and seek advice from professional advisors representing your interests.
Posted 1/4/23; updated 1/5/23
#BIIB #EASLY #LLY #ABOS #Lecanemab #ADUHELM #Donanemab #ACU193 #ACIU #Semorinemab #ACI24 #Crenezumab # #ALEC #AL002 #ALZN #AL001 #ATHA #Fosgonimeton #AXSM #AXS05 #BIVI #NE3107 #BTAI #BXCL501 #CGTX #CT1812 #KRTX #KarXT #PHAR #Leniolisib #PRTA #PRX012 #VCNX #Pepinemab #SAVA #Simufilam
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