Dr. Borger is the founder and retired CEO and Chairman of the Board of Vertex Pharmaceuticals.
ServoMed plans to complete enrollment in the first half of 2024 in the RewinD-LB Phase 2b clinical trial evaluating neframapimod in patients with Lewy body dementia.Topline data expected in second half of 2024
BOSTON, Feb. 7, 2024 (Globe Newswire) — CervoMed Inc. (NASDAQ: CRVO), a clinical-stage company developing treatments for degenerative brain diseases, today announces the appointment of Dr. Joshua Borger Did. He serves as the Board and Chairman of the Board. Dr. Borger is an innovative scientist and highly successful executive who brings extensive experience in drug development and leadership of a biopharmaceutical company to CerboMed as it moves toward a critical turning point. Topline data from the RewinD-LB Phase 2b clinical trial evaluating neflamapimod in dementia with Lewy bodies (DLB) is expected to be presented in the second half of 2024. The position of Chairman of the Board was previously held by CervoMed co-founder Dr. Sylvie Grégoire, who will continue in the role. To serve as a director.
CervoMed CEO John Arum, M.D., said: “We are very pleased to welcome Joshua, the founder of Vertex and a respected leader in the industry, to our Board of Directors.” The company has the potential to deliver a highly differentiated, first-to-market treatment option for DLB. This is an ideal time for Joshua's appointment and represents a potentially transformative experience for the company. We look forward to leveraging his wealth of experience and strategic insight as we move toward top-line effectiveness results with the hidden RewinD-LB. We look forward to fully deploying RewinD-LB during the first half of this year. We are on track to have top-line efficacy results in late 2024.”
Dr. Borger continued, “Neflamapimod has the potential to fundamentally change the lives of DLB patients and their caregivers, so I am thrilled to join the CervoMed team and board. I am an investor. We have been closely monitoring neframapimod since 2016. Dramatic advances over the past two years in understanding its mechanism of action against cholinergic degeneration and Phase 2a clinical results in DLB support the successful advancement of neframapimod. We have gained great confidence in our potential to be approved by Phase 2b and ultimately DLB. To lay the foundation for sustained growth and advance the company's mission, CervoMed's excellent team and I look forward to working closely with the board.”
Dr. Joshua Borger is an industry veteran who has held multiple roles in scientific and business leadership during a career spanning more than 40 years. He currently serves as Executive Chairman of Alkeus Pharmaceuticals. Dr. Borger founded Vertex in 1989 and served as CEO from 1992 until 2009. He continued to serve as chairman of the Vertex Board of Directors and the Vertex Science and Technology Committee until 2017. Prior to founding Vertex, Dr. Boger was Senior Director of Basic Chemistry. He joined the Merck Sharp & Dahmé Research Institute in Rahway, New Jersey, where he headed the Biophysical Chemistry Department and the Immunology and Inflammation Medicinal Chemistry Department. During his ten years at Merck, Dr. Borger established an international reputation for applying his computational modeling to the chemistry of drug design, using structure-based rational drug design as the basis for drug discovery programs. He became a pioneer. Dr. Boger holds a bachelor's degree in chemistry and philosophy from Wesleyan University and a master's degree and doctorate in chemistry from Harvard University. His postdoctoral research on molecular recognition was conducted in the laboratory of Nobel Prize-winning chemist Jean-Marie Lane in Strasbourg, France. He is the author of over 50 scientific publications and holds his 32 US patents in drug discovery and development.
About Dementia with Lewy Bodies (DLB)
DLB is the third most common degenerative brain disease (after Alzheimer's disease and Parkinson's disease), affecting approximately 700,000 people in the US and EU each. Patients with this disease accumulate protein deposits called Lewy bodies in nerve cells in the brain. This negatively affects cognitive abilities such as attention, judgment, and reasoning, as well as motor function. DLB patients are reported to have higher medical costs, longer hospital stays, lower quality of life, and higher caregiver distress levels when compared to Alzheimer's disease patients. Treatments for DLB have not been approved by the US FDA or the European Medicines Agency, and there are limited drugs in development. The current standard of care is cholinesterase inhibitor therapy, which is approved for use in Alzheimer's disease, but it only temporarily improves cognitive function and does not affect motor components in patients with DLB.
About nephramapimod
Neframapimod is an investigational, orally administered, small molecule brain penetrant that inhibits p38MAP kinase alpha (p38a). In preclinical studies, neframapimod specifically reversed synaptic dysfunction in the basal forebrain cholinergic system, the part of the brain most affected by DLB. Phase 1 and 2 clinical studies involving more than 300 participants have shown that neframapimod is generally well tolerated. Results from the AscenD-LB Phase 2a clinical trial showed that neframapimod significantly improved dementia severity (assessed by Clinical Dementia Rating Box Total, or CDR-SB) and functional mobility (time demonstrated significant improvement in performance (as assessed by up-and-go testing). , or TUG test) compared with placebo. At the highest dose evaluated, neframapimod also improved cognition. The therapeutic response of his AscenD-LB (assessed by blood test, plasma ptau181) in patients without Alzheimer's disease-related concomitant pathology was substantial (effect size > 0.7) and greater than in the overall patient population. The combined preclinical and clinical data are consistent with neflamapimod treating the underlying DLB disease process.
About the RewinD-LB Phase 2b study for Lewy body dementia
CervoMed's ongoing Phase 2b study, RewinD-LB, is a randomized, randomized trial evaluating oral neframapimod (40 mg three times daily) in up to 160 patients with prodromal DLB or mild dementia. This is a weekly double-blind, placebo-controlled clinical trial. D.L.B. Patients who complete the 16-week placebo-controlled study period will be able to continue on the study with open-label neframapimod treatment for an additional 32 weeks. Patients with AD-related comorbid conditions assessed by blood biomarkers (plasma ptau181) will be excluded. The primary endpoint of this study is change in his CDR-SB, and secondary endpoints include his TUG test, battery of cognitive tests, and clinician's overall impression of change. The RewinD-LB study is funded by his $21 million grant from the National Institutes of Health's National Institute on Aging, with costs paid as they are incurred during the study period. The study includes 41 sites (30 in the United States, eight in the United Kingdom, and three in the Netherlands), all of which have begun. More information about the RewinD-LB study, including contact information for ongoing clinical trial sites, is available at clinicaltrials.gov.
About Cervomed
CervoMed Inc. is a clinical-stage biotechnology company focused on developing treatments for degenerative diseases of the brain. The company is currently developing investigational neframapimod, an orally administered small molecule brain penetrant that inhibits p38MAP kinase alpha (p38a). Neframapimod has the potential to treat reversible aspects of synaptic dysfunction, the underlying neurodegenerative process that causes DLB and other major neurological disorders. Neframapimod is currently being evaluated in a Phase 2b trial in patients with DLB.
Forward-looking statements
This press release contains forward-looking statements, both express and implied, regarding our intentions, plans, beliefs, expectations or projections for the future, within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. will appear. Therapeutic potential of neframapimod and anticipated timing of clinical milestones. “believe”, “estimate”, “anticipate”, “expect”, “plan”, “intend”, “may”, “could”, “might”, “will” Words such as “will”, “should”, “approximately”, “may” or other words that convey uncertainty of future events or results may identify these forward-looking statements. Although each forward-looking statement contained herein is believed to have a reasonable basis, forward-looking statements by their nature involve known and unknown risks and uncertainties, many of which are beyond our control. are beyond our control and, as a result, actual results may be affected. material differences from those expressed or implied by forward-looking statements. Certain risks and uncertainties include, among other things, those related to: our available cash resources and the availability of additional funds on acceptable terms; Results of our clinical trials. the likelihood and timing of regulatory approval of neflamapimod or the nature of any feedback the Company may receive from the U.S. Food and Drug Administration; our ability to implement future business plans, forecasts and other expectations; general economic, political, business, industry and market conditions, inflationary pressures and geopolitical conflicts; and “Risk Factors” in the Company's Quarterly Report on Form 10-Q for the three months ended September 30, 2023, filed with the Securities and Exchange Commission (SEC) on November 13, 2023. Other factors discussed under the headings. and other filings that we may make from time to time with the SEC. The forward-looking statements contained in this press release speak only as of the date of this press release (or earlier dates, if identified). The Company undertakes no obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except to the extent required by law.
Investor contact information:
PJ Kelleher
Life science advisor
investors@cervomed.com
617-430-7579
Media contact:
Tressa Frankel
Health + Commerce
tressa@healthandcommerce.com
