Alector creating disruptive change in the way the world treats neurodegenerative disorders

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02.08.20 05:31:39
Alector to Present Data from the AL001 Phase 2 Open-Label Study in Frontotemporal Dementia at the 2020 Alzheimer’s Association International Conference
July 21, 2020 at 5:00 PM EDT

SOUTH SAN FRANCISCO, Calif., July 21, 2020 (GLOBE NEWSWIRE) -- Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today announced that the company will highlight preliminary data from a Phase 2 open-label study evaluating AL001 in individuals with frontotemporal dementia at the upcoming 2020 Alzheimer’s Association International Conference being held virtually, July 27-31, 2020.

Details for the oral presentation:

Presentation Title: AL001 Restores CSF PGRN Levels and Normalizes Disease-associated Biomarkers in Individuals with Frontotemporal Dementia due to Heterozygous Mutations in the Progranulin Gene

Session Name: Human: Putative Therapeutic Results for Alzheimer’s and Related Dementias
Presenter: Robert Paul, M.D., Ph.D., Chief Medical Officer, Alector
Date: Presentation will be available on-demand beginning Tuesday, July 28, 2020 at 6 p.m. Eastern Time
Alector | 15,67 $
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02.08.20 05:33:05
Alector Doses First Patient in Pivotal Phase 3 INFRONT-3 Trial Evaluating AL001 in Patients with Frontotemporal Dementia
July 24, 2020 at 8:30 AM EDT

Trial will enroll up to 180 symptomatic and pre-symptomatic participants with FTD-GRN gene mutation at multiple sites in the U.S., Europe and Australia
There are currently no FDA-approved treatments for frontotemporal dementia
SOUTH SAN FRANCISCO, Calif., July 24, 2020 (GLOBE NEWSWIRE) -- Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today announced dosing of the first patient in its pivotal Phase 3 clinical trial, named INFRONT-3, evaluating AL001 in people at risk for or with frontotemporal dementia due to a progranulin gene mutation (FTD-GRN). AL001 is the company’s wholly owned, investigational human monoclonal antibody designed to modulate progranulin, a key regulator of immune activity in the brain.

Frontotemporal Dementia (FTD) is a rapidly progressing and severe form of dementia found most frequently in people less than 65 years old at the time of diagnosis. It affects 50,000 to 60,000 people in the United States and roughly 110,000 in the European Union. There are multiple heritable forms of FTD, and FTD-GRN patients represent 5% to 10% of all people with FTD. There are currently no approved treatments options available for FTD.

“The initiation of our global pivotal Phase 3 trial of AL001 is a significant step towards achieving our mission of helping patients suffering from FTD and other neurodegenerative diseases,” said Robert Paul, M.D., Ph.D., chief medical officer of Alector. “Our Phase 3 study has been designed to measure slowing of disease progression in both symptomatic and pre-symptomatic FTD-GRN patients. We believe the INFRONT-3 trial will successfully demonstrate AL001’s ability to significantly alter the course of FTD and potentially transform the lives of people affected by this condition. We are incredibly grateful to the patients, healthcare professionals and clinical sites that participated during earlier phases of study, allowing us to rapidly progress to Phase 3 evaluation in less than two years.”

The randomized, double-blind, placebo-controlled trial will enroll up to 180 FTD-GRN mutation carriers across approximately 50 sites in the United States, Europe and Australia. Symptomatic and pre-symptomatic participants will be randomized to receive AL001 or placebo intravenously every four weeks. Participants will also be given the option to continue receiving treatment in an open-label extension study.

The primary endpoint of the pivotal Phase 3 trial is to measure the effect of AL001 on clinical decline by utilizing the CDR® plus NACC FTLD-SB assessment, which evaluates clinical impairments in behavior, language, memory, judgment, and functional activities in trial participants. In addition, the trial will assess secondary clinical endpoints, multiple biomarkers and safety.

To learn more about the Phase 3 trial, please visit https://clinicaltrials.gov/.

About AL001
AL001 is a wholly owned, investigational human monoclonal antibody designed to modulate progranulin, a key regulator of immune activity in the brain with genetic links to multiple neurodegenerative disorders, including FTD, Alzheimer’s disease, and Parkinson’s disease. AL001 aims to increase the level of progranulin in humans by inhibiting a progranulin degradation mechanism. AL001 was discovered and engineered in collaborative effort between Alector and Adimab, LLC.

AL001 has received Orphan Drug designation for the treatment of FTD and Fast Track designation for the treatment of FTD-GRN from the U.S. Food and Drug Administration.

https://investors.alector.com/news-releases/news-release-det…
Alector | 15,67 $
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02.08.20 05:35:32
Alector Announces Promising Preliminary Data from AL001 Phase 1b and Phase 2 Open-Label Long-Term Dosing Study of People with Frontotemporal Dementia
July 28, 2020 at 6:00 PM EDT

- AL001 was generally safe and well-tolerated in Phase 1b study and after continuous dosing in 15 asymptomatic and symptomatic FTD-GRN participants in Phase 2 study

- Treatment with AL001 in Phase 2 study resulted in sustained restoration of plasma progranulin levels in all FTD-GRN participants back to normal range and the majority of symptomatic FTD-GRN participants showed a decrease in plasma neurofilament light chain (NfL) levels from baseline

- Pivotal Phase 3 study initiated in July 2020

SOUTH SAN FRANCISCO, Calif., July 28, 2020 (GLOBE NEWSWIRE) -- Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today announced preliminary data from its Phase 1b and open-label Phase 2 studies of AL001, for the treatment of people with frontotemporal dementia with a progranulin gene (GRN) mutation (FTD-GRN). AL001 is the company’s wholly owned, investigational human monoclonal antibody designed to modulate progranulin, a key regulator of immune activity in the brain. The data were presented today at the virtual 2020 Alzheimer’s Association International Conference (AAIC) by Robert Paul, M.D., Ph.D., chief medical officer of Alector.

Frontotemporal dementia is a rapidly progressing and severe form of dementia found most frequently in people less than 65 years old at the time of diagnosis. There are multiple heritable forms of FTD, and FTD-GRN represents 5% to 10% of all people with FTD. There are currently no FDA-approved treatment options for FTD.

“We continue to discover and develop therapies in pursuit of our goal to eradicate neurodegenerative diseases,” said Arnon Rosenthal, Ph.D., co-founder and chief executive officer of Alector. “The encouraging results from the Phase 1b and Phase 2 studies of AL001 represent substantial progress. With our rapid initiation of a pivotal Phase 3 trial, we hope that it is only a matter of time before AL001 is the first treatment option for people living with this devastating disease.”

The ongoing Phase 2, multicenter, open-label, study is evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), fluid and imaging biomarkers and the effect on clinical outcome assessments of AL001. The Phase 2 study is expected to enroll up to 40 participants who will receive treatment with AL001 for up to 96 weeks. The study has completed enrollment of 10 symptomatic patients with FTD-GRN and 5 asymptomatic individuals carrying a GRN mutation. Enrollment for FTD patients with C9orf72 mutations is currently ongoing.

Due to the COVID-19 pandemic, several clinical sites for the Phase 2 study were temporarily closed or conducted reduced or remote patient assessments during the evaluation period. As a result, some participants missed a dose of AL001 or missed clinical assessments during the treatment period. Alector is working closely with the sites, investigators and participants to manage future effects of the COVID-19 pandemic on the study.

“AL001 was well-tolerated and caused sustained restoration of plasma progranulin levels in all FTD-GRN participants back to normal levels. These preliminary findings are encouraging and also suggest that long-term treatment with AL001 has the potential to slow disease progression in patients with FTD-GRN as measured by relevant disease biomarkers,” said Dr. Paul. “Although the COVID-19 pandemic impacted data collection for this initial analysis, we believe these early results are quite promising. We continue to advance the Phase 2 study and would like to thank the participants, their families and our study collaborators for their support in advancing AL001 forward.”

A summary of the preliminary results from the Phase 2 study are as follows:

A total of 15 participants with symptomatic and asymptomatic FTD-GRN have been evaluated in the Phase 2 study as of May 14, 2020.
AL001 was observed to be generally safe and well-tolerated. There were no treatment-related serious adverse events observed in participants receiving AL001 treatment.
AL001 led to sustained restoration of plasma progranulin levels in all FTD-GRN participants back to the normal range.
Preliminary data from the symptomatic FTD-GRN participants showed a decrease in plasma NfL levels from baseline in the majority of participants at the last measured time point.
In the presented case study of a symptomatic FTD-GRN participant, with the longest continuous treatment with AL001 for over 28 weeks, treatment resulted in a sustained decrease in plasma NfL by 29% from baseline.
These early data suggest that longer term treatment with AL001 could lead to sustained increase in PGRN and sustained reduction in plasma NfL over time. Alector plans to present additional Phase 2 data highlighting clinical and biomarker endpoints in the future.

In July 2020, Alector announced that the first patient was dosed in INFRONT-3, a global, pivotal Phase 3 trial evaluating the efficacy and safety of AL001 in symptomatic and pre-symptomatic people with FTD-GRN. AL001 has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration for FTD.

https://investors.alector.com/news-releases/news-release-det…
Alector | 15,67 $


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