Vigil Neuroscience Receives FDA Fast Track Designation for


CAMBRIDGE, Mass., Nov. 01, 2022 (GLOBE NEWSWIRE) — Vigil Neuroscience, Inc. (Nasdaq: VIGL), a clinical-stage biotechnology company committed to harnessing the power of microglia for the treatment of neurodegenerative diseases, announced today that the United States Food and Drug Administration (FDA) granted Fast Track Designation to VGL101 for the treatment of patients with adult leukoencephalopathy with axonal spheroids and pigmented glia (ALSP). VGL101, Vigil’s lead product candidate, is a TREM2 agonist monoclonal antibody currently being evaluated in a Phase 1 trial in healthy volunteers.

“ALSP is a devastating disease that affects approximately 10,000 people in the United States without any approved treatment. We believe this FDA Fast Track designation recognizes the significant unmet need of ALSP patients and the therapeutic potential of VGL101” , said Ivana Magovčević-Liebisch, Ph.D., JD, President and CEO of Vigil, “We are excited about the progress we have made in advancing VGL101 and we remain on track to communicate phase 1 frontline data and initiate a phase 2 proof of concept trial for VGL101 in ALSP this quarter.”

The Fast Track designation is designed to facilitate the development and expedite consideration of therapies for serious conditions, such as ALSP, and address an unmet medical need. Programs with the Fast Track designation can benefit from early and frequent communication with the FDA as well as the possibility of priority review and continued marketing application submission.

About VGL101
VGL101, Vigil’s lead product candidate, is a fully human monoclonal antibody targeting human trigger receptor expressed on myeloid cells 2 (TREM2), which is responsible for maintaining microglial cell function. TREM2 deficiency is thought to be the cause of certain neurodegenerative diseases. VGL101 is being developed for the treatment of rare microgliopathies, such as ALSP, as well as other neurodegenerative diseases where TREM2 and/or microglia deficiency are believed to be a key driver of the disease pathway.

About Vigil Neuroscience
Vigil Neuroscience is a clinical-stage microglia-focused therapeutics company focused on developing treatments for rare and common neurodegenerative diseases by restoring vigilance to microglia, the brain’s sentinel immune cells. We use modern neuroscientific drug development tools across multiple therapeutic modalities in our efforts to develop precision-based therapies to improve the lives of patients and their families.

Forward-looking statements
This press release includes certain disclosures that contain “forward-looking statements” of Vigil Neuroscience (“Vigil” or the “Company”) that are made pursuant to the safe harbor provisions of the federal securities laws, including, without not limited to, express or implied statements regarding: the addressable market for VGL101; the progress and timing of preclinical and clinical development of Vigil’s programs, including data availability and expected timing for reporting data from the Phase 1 VGL101 trial, initiation of its proof-of-concept trial of phase 2 in the fourth quarter of 2022; the belief that the Fast Track designation recognizes the significant unmet need of ALSP patients and the therapeutic potential of VGL101; beliefs regarding the advisability of early and frequent communications with the FDA as well as the possibility of priority review and continued submission of the marketing application; and expectations regarding the development of VGL101 in ALSP and other indications. Forward-looking statements are based on Vigil’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties associated with the uncertainties inherent in the identification and development of product candidates, including the conduct of research activities and the launch and the completion of preclinical studies and clinical trials; uncertainties regarding the availability and timing of results and data from preclinical and clinical studies; the timing of the Company’s ability to submit and obtain regulatory approval for investigational new drug applications and to initiate additional clinical trials; whether the results of preclinical studies will be predictive of the results of preclinical studies and subsequent clinical trials; the Company’s ability to initiate and complete its current and planned clinical trials and its ability to work with the FDA to successfully lift the partial clinical hold; whether Vigil’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure needs; uncertainties related to the impact of the COVID-19 pandemic on its business and operations; as well as the risks and uncertainties identified in the Company’s filings with the Securities and Exchange Commission (SEC), including Vigil’s IPO Registration Statement, its Annual Report on Form 10-K for fiscal year ended December 31, 2021, its Quarterly Report on Form 10-Q for the six months ended June 30, 2022 and in all subsequent filings with the SEC, including its Quarterly Report on Form 10-Q for the nine months ended September 30, 2022. Forward-looking statements contained in this announcement are made as of this date, and Vigil undertakes no obligation to update such information except as required by applicable law. Readers should not rely on any information on this page to be current or accurate after its publication date.


Comments are closed.