Alector Initiates First-in-Human Dosing in Phase 1 Study of AL101 for the Treatment of Neurodegenerative Diseases

January 6, 2020 at 8:30 AM EST
  • AL101 is the company’s second product candidate designed to increase the level of progranulin in the human brain. 

  • Progranulin has been identified as a key regulator of microglial function in the brain with strong genetic links to multiple neurodegenerative disorders.

SOUTH SAN FRANCISCO, Calif., Jan. 06, 2020 (GLOBE NEWSWIRE) -- Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today announced that in December 2019, it initiated dosing in healthy volunteers in its Phase 1 study of AL101, an investigational product candidate designed to increase progranulin levels. The Phase 1 study is designed to assess the safety and tolerability of AL101 in healthy volunteers, as well as the pharmacokinetics (PK), pharmacodynamics (PD) and bioavailability of intravenously and subcutaneously administered doses of AL101.

AL101 is Alector’s second product candidate targeting the progranulin pathway to enter the clinic in the last two years.

“Progranulin is a regulator of immune activity in the brain. Human genetics have shown that even moderately reduced progranulin expression may lead to an increased risk of developing neurodegenerative disorders, such as Alzheimer’s disease and Parkinson’s disease. We strongly believe that increasing progranulin in the brain of patients suffering from these diseases may counteract disease pathology,” said Robert Paul, M.D., Ph.D., chief medical officer of Alector.

“This study will pave the way for exploring multiple indications for progranulin therapy as well as delivery formulations of this novel investigational medicine. The results will inform our decisions on future development of AL101 for neurodegeneration,” said Robert King, Ph.D., chief development officer of Alector.

The Phase 1 study of AL101 is a randomized, double-blind, placebo-controlled trial expected to enroll up to 42 healthy volunteers at a clinical study site in the United States. The ClinicalTrials.gov Identifier for the AL101 study is: NCT04111666.

About AL101
AL101 is Alector’s wholly-owned human monoclonal antibody and second product designed to increase progranulin, a regulator of immune activity in the brain with genetic links to multiple neurodegenerative disorders. Mutations that moderately reduce the expression levels of progranulin have been shown to increase the risk of developing Alzheimer’s disease and Parkinson’s disease, and increased progranulin levels have been demonstrated to be protective for these diseases in animal models.

AL101 has the potential to be developed for the treatment of Alzheimer’s disease and Parkinson’s disease. AL101 received orphan drug designation from the U.S. Food and Drug Administration for the treatment of FTD in July 2019.

About Alector
Alector is a clinical stage biotechnology company pioneering immuno-neurology, a novel therapeutic approach for the treatment of neurodegenerative diseases. Immuno-neurology targets immune dysfunction as a root cause of multiple pathologies that are drivers of degenerative brain disorders. Alector is developing a broad portfolio of programs designed to functionally repair genetic mutations that cause dysfunction of the brain’s immune system and enable the rejuvenated immune cells to counteract emerging brain pathologies. The Company’s product candidates are supported by biomarkers and target genetically defined patient populations in frontotemporal dementia and Alzheimer’s disease. Alector is headquartered in South San Francisco, California. For additional information, please visit www.alector.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking” statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on our beliefs and assumptions and on information currently available to us on the date of this press release and may involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These statements include but are not limited to statements regarding the Company’s plans for and anticipated benefits and mechanism of the Company’s product candidates, the timing and objectives of the clinical studies and anticipated regulatory and development milestones. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. Important factors that could cause our actual results to differ materially are detailed from time to time in the reports that Alector files with the Securities and Exchange Commission, including in our quarterly report on Form 10-Q that is filed with the Securities and Exchange Commission (“SEC”).  Copies of reports filed with the SEC are posted on Alector’s website and are available from Alector without charge.

Source: Alector, Inc.

Contacts
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Source: Alector, Inc.