Vigil Neuroscience Launches ALSPAware to Provide Access to No-cost Genetic Testing and Counseling for Adult-Onset Leukoencephalopathy with Axonal Spheroids and Pigmented Glia (ALSP)

– New genetic testing initiative designed to enable improved patient diagnosis of ALSP, a devastating, rare genetic neurodegenerative disease –

– Through ALSPAware, individuals and healthcare providers can now access no-cost, expedited genetic testing and counseling for those suspected to have ALSP –

WATERTOWN, Mass., May 08, 2023 (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, today announced the launch of ALSPAware, a new program providing no-cost genetic testing and counseling services for the diagnosis of adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP). The program is coordinated by InformedDNA®, the largest independent provider of genetic counseling services, and PreventionGenetics, an Exact Sciences Company running an accredited laboratory that delivers high-quality genetic testing.

"Limited access to genetic testing and appropriate counseling has led to diagnostic challenges affecting not only those living with ALSP, but also the healthcare providers hoping to treat the disease. Only about one-third of people living with ALSP receive a correct diagnosis when symptoms first appear, resulting in a delay that can significantly increase the burden of this devastating genetic condition,” said Ivana Magovčević-Liebisch, Ph.D., J.D., President and Chief Executive Officer of Vigil. “We believe that everyone deserves access to the services necessary to make the diagnostic journey as efficient and convenient as possible, and we are proud to be taking this important step forward in supporting the ALSP community.”

ALSPAware offers no-cost, confidential genetic testing and counseling services to U.S. residents age 18 and over. Developed with both patients and healthcare providers in mind, the program includes a single gene confirmatory test for individuals with a family history of ALSP, as well as a custom gene panel available for physicians to use in diagnosing adult-onset neurological diseases. Trained genetic counselors are available to facilitate testing and discuss results, and participants will have access to a range of specialized information and services created to support participants and their families. By increasing access to genetic testing for both individuals and healthcare providers, we believe ALSPAware has the potential to help reduce initial misdiagnosis of this disease, while also providing appropriate disease management services for those living with ALSP.

Increased access to genetic testing has been an important goal in the ALSP community for many years. ALSPAware was developed with input from leaders from the patient advocacy community including Sisters’ Hope Foundation, United Leukodystrophy Foundation and Hunter’s Hope Foundation, to ensure the program addresses the key challenges patients, caregivers and healthcare providers face during the genetic testing and counseling process.

To learn more about ALSPAware or find out how to access genetic testing services through the program, visit www.informedDNA.COM/ALSPAware.

About ALSP

ALSP is a rare, inherited, autosomal dominant neurological disease with high penetrance. It is caused by a mutation to the CSF1R gene and affects an estimated 10,000 people in the U.S., with similar prevalence in Europe and Japan. The disease generally presents itself in adults in their forties, is diagnosed through genetic testing and established clinical/radiologic criteria and is characterized by cognitive dysfunction, neuropsychiatric symptoms, and motor impairment. These symptoms typically exhibit rapid progression with a life expectancy of approximately six to seven years on average after diagnosis, causing significant patient and caregiver burden. There are currently no approved therapies for the treatment of ALSP, underlining the high unmet need in this rare indication.

About Vigil Neuroscience

Vigil Neuroscience is a clinical-stage biotechnology company focused on developing treatments for both rare and common neurodegenerative diseases by restoring the vigilance of microglia, the sentinel immune cells of the brain. We are utilizing the tools of modern neuroscience drug development across multiple therapeutic modalities in our efforts to develop precision-based therapies to improve the lives of patients and their families. VGL101, our lead candidate, is a fully human monoclonal antibody agonist targeting human triggering receptor expressed on myeloid 2 (TREM2) and is in a Phase 2 proof-of-concept trial in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), a rare and fatal neurodegenerative disease. Vigil is also conducting Investigational New Drug Application (IND)-enabling studies with a novel small molecule TREM2 agonist program to treat common neurodegenerative diseases associated with microglial dysfunction, with an initial focus on Alzheimer’s disease (AD) in genetically defined subpopulations. For more information visit www.vigilneuro.com. 

About PreventionGenetics
Founded in 2004 and located in Marshfield, Wisconsin, PreventionGenetics, a wholly owned subsidiary of Exact Sciences Corp., is a Clinical Laboratory Improvement Amendments (CLIA) and International Organization for Standardization (ISO) 15189:2012 accredited laboratory. PreventionGenetics delivers clinical genetic testing of the highest quality at fair prices with exemplary service to people around the world. PreventionGenetics provides tests for nearly all clinically relevant genes including the powerful and comprehensive whole genome sequencing test, PGnome® and whole exome sequencing test, PGxome®.

About InformedDNA

InformedDNA® is the country’s leading applied genomics solutions company, helping people harness the full power of the genomics revolution. With a large staff of board-certified genetics specialists, InformedDNA ensures that health organizations have access to the highest quality genomics insights to optimize clinical decisions and biopharma companies have support to meet the challenges of precision medicine clinical trials. InformedDNA's solutions extend beyond successful clinical trial execution to maximize post-market success in targeted populations. www.InformedDNA.com.

Vigil Neuroscience Forward-Looking Statements

This press release includes certain disclosures that contain “forward-looking statements” of Vigil Neuroscience’s (“Vigil” or the “Company”) that are made pursuant to the safe harbor provisions of the federal securities laws, including, without limitation, express or implied statements regarding: the Company’s strategy, business plans and focus; the potential design, access, benefits and success of ALSPAware, including the belief that the program will ease the diagnostic journey for patients and their families; the progress and timing of the preclinical and clinical development of Vigil’s programs, including the availability of data and expected timing for reporting data from the VGL101 Phase 2 proof-of-concept trial and the filing of an IND application for its small molecule TREM2 agonist program; 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 related to uncertainties inherent in the identification and development of product candidates, including the conduct of research activities and the initiation and completion of preclinical studies and clinical trials; uncertainties as to 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 clearance for investigational new drug applications and initiate additional clinical trials; whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials; the Company’s ability to initiate and complete its current and expected clinical trials; whether Vigil’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; uncertainties associated with 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 Annual Report on Form 10-K for the year ended December 31, 2022 and in any subsequent filings it may make with the SEC. Forward-looking statements contained in this announcement are made as of this date, and Vigil undertakes no duty to update such information except as required under applicable law. Readers should not rely upon the information on this page as current or accurate after its publication date.

Investor Contact:

Sarah Carmody

scarmody@vigilneuro.com 

Media Contact:

Megan McGrath

MacDougall Advisors

mmcgrath@macdougall.bio 

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