stockrafter
2 주 전
A marketed competitor, Lecanemab, is going the SC-AI route,
“EISAI COMPLETES ROLLING SUBMISSION TO US FDA FOR LEQEMBI® (LECANEMAB-IRMB) ”
https://media-us.eisai.com/2024-10-31-Eisai-Completes-Rolling-Submission-to-US-FDA-for-LEQEMBI-R-lecanemab-irmb-Biologics-License-Application-for-Subcutaneous-Maintenance-Dosing-for-the-Treatment-of-Early-Alzheimers-Disease-Under-the-Fast-Track-Status
Feeds suspicion Acumen is developing a triple combo, Sabirnetug-hyaluronidase-autoinjectior, with Halozyme.
An upcoming fireside chat might shed light on the next P2 clinical trial for SC sabirnetug….
”UBS Global Healthcare Conference on Wednesday, Nov. 13, 2024, at 1:15 p.m. PT (4:15 p.m. ET).”
https://investors.acumenpharm.com/news-releases/news-release-details/acumen-pharmaceuticals-participate-ubs-global-healthcare
On a side note a short video on the p-TAU-127 biomarker screening presentation has been posted…
https://www.neurologylive.com/view/acumen-pharmaceuticals-phase-2-advancements-ad-screening-todd-feaster-psyd
Which as noted earlier, sub-3 with be history after the presentation.....looking good so far......
stockrafter
4 주 전
The two current competitors….Kisunla and Leqembi
https://alzheimersweekly.com/how-to-choose-between-leqembi-vs-kisunla/
Good article on current and upcoming competitors…
......“Beginning a New Era of Precision Alzheimer’s Therapeutics”
https://www.insideprecisionmedicine.com/topics/translational-research/beginning-a-new-era-of-precision-alzheimers-therapeutics/
Prothena has several up and coming ALS drugs, comment on website gives more incentive for Acumen to develop SC sabirnetug along with an AI.
........Prothena Provides Updates on PRX012, PRX123, Birtamimab and Portfolio Programs
.......“Prothena is developing a molecule that we certainly hope will be delivered at home, once monthly, by subcutaneous administration and can be self-administered. I think that from a treatment burden perspective that allows us to start to think about the idea that any patient should have access to these types of approaches, and we think that that’s very important,” said Gene Kinney, PhD, Prothena CEO and president.”
https://www.prothena.com/pipeline/
Suspect days of sub 3 bucks will be history after the presentation later this week.
https://finance.yahoo.com/news/acumen-pharmaceuticals-deliver-breaking-presentation-120000342.html
stockrafter
1 월 전
Significant comments made in this discussion last week.......
Discussion is very good, best part is little more than 4:00 into discussion Siemers mentions Sabirnetug Efficacy is better and fewer side effects then the competition, Lecanemab , and Donanemab.....Cool......
"UNDERSTANDING ALZHEIMER’S AND THE PATH FORWARD, WITH ERIC SIEMERS, MD"
(Eric Siemers, MD, chief medical officer at Acumen Pharmaceuticals, )
"Early detection of Alzheimer's is vital for effective treatment, according to Eric Siemers, MD, who emphasizes the importance of caregiver support and proactive planning for families navigating the diagnosis."
https://www.theeducatedpatient.com/view/understanding-alzheimer-s-and-the-path-forward-with-eric-siemers-md
stockrafter
1 월 전
SP is looking good today, along with volume.....
A lot of news out there on the competition LEQEMBI, and Donanemab, giving insight on Sabirnetug potential.
Interesting news from a couple days on wasted volumes of the competition, giving insight into the cost of the drug and giving yet another reason for a prefilled AI.
https://www.uclahealth.org/news/release/smaller-vial-size-alzheimers-drug-could-save-medicare
"The researchers on the study, published(Link is external) October 14 in the peer-reviewed JAMA Internal Medicine, estimate that Medicare could waste up to $336 million annually due to discarded medication."
“However, we estimate lecanemab waste to be only 5.8%, rendering current policy ineffective, and sounding the bell that further policy changes are likely needed,” he said.
stockrafter
1 월 전
Lonza is on board, and will make a good CDMO partner.
"If The CDMO Shoe Fits, Wear It Now"
"In November of 2022, Acumen entered an agreement with Lonza that granted it a worldwide non-exclusive license to use Lonza’s glutamine synthetase gene expression system to manufacture and commercialize ACU193/sabirnetug."
"Although that predates his joining Acumen (in February of this year), Doherty says there had been an earlier round of work performed with a different set of providers, “but as we announced, we are working with Lonza moving forward.”
https://www.outsourcedpharma.com/doc/if-the-cdmo-shoe-fits-wear-it-now-0001
stockrafter
1 월 전
Yes, one of these days, but still accumulating so don't want it to move up too fast.
The presentation last week is worth listening to, and doing a thorough review of the PowerPoint info. They did a good job of explaining sabirnetug development and progress. An interesting (and exciting) detail is improvements were measured in a few biomarkers after only 3 doses.
Slide 68 show they are working with Halozyme for SC injection, completed Phase 1, and Phase 2 will start soon. IMO, they will develop an autoinjector for sabirnetug using Holzyme Enhanze and AI. At the end of the Q&A section the speaker mentions the difficulty of developing an AI.
Will be waiting for the current ALTITUDE trial update, a good update will move the SP, and planning on being all in by then.
"Expected Phase 1 subcutaneous topline results 1Q25"
"Expected completion of enrollment of ALTITUDE-AD 1H25"
https://investors.acumenpharm.com/static-files/c6a0d4a6-b7ec-421c-9230-d245ec96f9b4
tw0122
1 월 전
Add in $2.30s ready to go one of these days .. Sabirnetug is the first humanized monoclonal antibody to clinically demonstrate selective target engagement of AßOs in AD patients. Soluble AßOs are a highly toxic form of Aß that begin to accumulate before a clinical diagnosis of AD and are an early and persistent trigger of synaptic dysfunction and neurodegeneration. Acumen is developing sabirnetug as a potential next generation antibody treatment for early AD. Acumen is currently enrolling patients in the ALTITUDE sabirnetug -AD study, a Phase 2 clinical trial designed to evaluate the clinical efficacy and safety of intravenous sabirnetug in patients with early AD. Acumen is also evaluating a subcutaneous formulation of sabirnetug in a Phase 1 pharmacokinetic comparison study in healthy volunteers.
The extended collaboration builds upon an existing successful relationship between the two companies, in which Lonza provides DS manufacturing for the Phase 2 clinical supply of sabirnetug. Under the terms of the extended agreement, Lonza will manufacture cGMP DP of sabirnetug for the ongoing and future clinical phases and support the potential commercial launch at its industry-leading state-of-the-art DP manufacturing facility in Visp, Switzerland. Lonza will also provide quality control and stability testing as part of the collaboration.
Peter Droc, Head of Drug Product Services, Lonza, commented: “Our team of experts has extensive experience in supporting the clinical and commercial manufacture of drug products. In line with our strategy to offer an integrated end-to-end offering for biologics manufacturing, we are looking forward to collaborating with Acumen to advance its innovative and promising drug candidate in the clinic and beyond.”
James Doherty, President and Chief Development Officer, Acumen Pharmaceuticals, added: “The extension of our collaboration comes at a time when we’re advancing our clinical programs for sabirnetug with more than 50 Phase 2 sites activated across the U.S., Canada, U.K. and EU. We look forward to continuing our work with Lonza and delivering a potential next-generation treatment for early Alzheimer’s disease.”
About Sabirnetug (ACU193)
Sabirnetug (ACU193) is a humanized monoclonal antibody (mAb) discovered and developed based on its selectivity for soluble amyloid beta oligomers (AßOs), which are a highly toxic and pathogenic form of Aß, relative to Aß monomers and amyloid plaques. Soluble AßOs have been observed to be potent neurotoxins that bind to neurons, inhibit synaptic function and induce neurodegeneration. By selectively targeting toxic soluble AßOs, sabirnetug aims to address the hypothesis that soluble AßOs are an early and persistent underlying cause of the neurodegenerative process in Alzheimer’s disease (AD). Sabirnetug has been granted Fast Track designation for the treatment of early AD by the U.S. Food and Drug Administration and is currently being evaluated in a Phase 2 study in patients with early AD.
About Acumen Pharmaceuticals, Inc.
Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers (AßOs) for the treatment of Alzheimer’s disease (AD). Acumen’s scientific founders pioneered research on AßOs, which a growing body of evidence indicates are early and persistent triggers of Alzheimer’s disease pathology. Acumen is currently focused on advancing its investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody that selectively targets toxic soluble AßOs, in its ongoing Phase 2 clinical trial ALTITUDE-AD (NCT06335173) in early symptomatic Alzheimer’s disease patients, following positive results in its Phase 1 trial INTERCEPT-AD. The company is headquartered in Newton, Mass. For more information, visit www.acumenpharm.com.
tw0122
1 년 전
Acumen Pharmaceuticals Presents Positive Topline Results from First-in-Human Phase 1 Study of ACU193 for Early Alzheimer’s Disease at the Alzheimer’s Association International Conference (AAIC) 2023
Source: GlobeNewswire Inc.
Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AßOs) for the treatment of Alzheimer’s disease (AD), today presented positive topline results from the Phase 1 INTERCEPT-AD trial of ACU193, the first clinical-stage AßO targeting antibody therapy in early AD, at the Alzheimer’s Association International Conference (AAIC®) 2023, taking place in Amsterdam and online from July 16-20, 2023.
Topline results demonstrated that ACU193 was generally well-tolerated with a compelling overall safety profile, meeting the primary objective of this Phase 1, first-in-human, randomized, double-blind, placebo-controlled study in both single and multiple doses in 60 participants with early AD. Dose levels were 2, 10, 25 and 60 mg/kg for one to three doses administered intravenously. An analysis of change in amyloid plaque load, as measured by positron emission tomography (PET) SUVr, demonstrated a rapid, dose-related mean decrease at the higher dose levels studied (60 mg/kg every 4 weeks [Q4W] and 25 mg/kg every 2 weeks [Q2W]). This finding is comparable to mean amyloid plaque decreases of approved Aß monoclonal antibodies at similar time points in their clinical development. The overall rate of amyloid related imaging abnormalities – edema (ARIA-E) was 10.4%, which included one case of symptomatic ARIA-E (2.1%). Pharmacokinetic results in serum and cerebrospinal fluid (CSF) demonstrated statistically significant dose proportionality and support monthly dosing of ACU193. Statistically significant, dose-related central target engagement was observed as measured by ACU193-AßO complex, establishing the first target engagement assay developed that is specific to an AßO-targeting antibody. An exposure response relationship (Emax) model revealed near maximal target engagement with repeated dosing at 25 mg/kg and 60 mg/kg.
“We are very pleased to present the first clinical data from our Phase 1 INTERCEPT-AD study at AAIC. ACU193’s observed dose-related central target engagement, rapid reduction of amyloid plaque and compelling safety profile validate our confidence in ACU193’s differentiated mechanism of action: selectively targeting amyloid beta oligomers,” said Daniel O’Connell, President and Chief Executive Officer of Acumen. “We believe that the robust data package generated by this comprehensive Phase 1 study establishes ACU193’s broad therapeutic index and guides a future clinical dosing rationale. We look forward to an anticipated interaction with the FDA in the fourth quarter to inform our next phase of development for ACU193.”
ACU193 Demonstrated Rapid, Dose-Related, Statistically Significant Amyloid Plaque Reduction
Higher doses of ACU193 (60 mg/kg Q4W and 25 mg/kg Q2W) showed a statistically significant reduction in amyloid plaque load as determined by amyloid PET after 6-12 weeks (from baseline to endpoint within cohorts (p = 0.01)). This finding provides evidence that ACU193 is active in the brain.
Mean Reduction in Amyloid Plaque (Centiloids)
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