CervoMed Awarded the Prix Galien USA 2024 Prize for Best Startup
CervoMed (NASDAQ: CRVO) has been awarded the Prix Galien USA 2024 prize in the Best Startup category, selected from 43 nominees. The award recognizes the company's progress in developing the first treatment for Dementia with Lewy bodies (DLB), a condition affecting over 1.4 million patients in the U.S. and EU. The company is approaching topline results for their RewinD-LB Phase 2b clinical trial of neflamapimod in December. The Prix Galien USA, established in 2007, is considered America's preeminent prize for scientific advances in life sciences.
CervoMed (NASDAQ: CRVO) è stata premiata con il Prix Galien USA 2024 nella categoria Miglior Startup, scelto tra 43 nominati. Il premio riconosce i progressi dell'azienda nello sviluppo del primo trattamento per la Demenza con corpi di Lewy (DLB), una condizione che colpisce oltre 1,4 milioni di pazienti negli Stati Uniti e nell'Unione Europea. L'azienda si avvicina ai risultati preliminari del loro studio clinico RewinD-LB di fase 2b di neflamapimod previsto per dicembre. Il Prix Galien USA, istituito nel 2007, è considerato il premio di maggior prestigio in America per i progressi scientifici nelle scienze della vita.
CervoMed (NASDAQ: CRVO) ha sido galardonada con el Prix Galien USA 2024 en la categoría de Mejor Startup, seleccionada entre 43 nominados. El premio reconoce el avance de la empresa en el desarrollo del primer tratamiento para la Dementia con cuerpos de Lewy (DLB), una condición que afecta a más de 1.4 millones de pacientes en EE. UU. y la UE. La compañía se acerca a los resultados preliminares de su ensayo clínico RewinD-LB fase 2b de neflamapimod previsto para diciembre. El Prix Galien USA, establecido en 2007, se considera el premio más prestigioso de América por los avances científicos en las ciencias de la vida.
CervoMed (NASDAQ: CRVO)는 43명의 후보자 중에서 선정되어 Prix Galien USA 2024 최우수 스타트업 부문에서 수상했습니다. 이 상은 미국과 EU에서 140만 명 이상에게 영향을 미치는 루이체 노인성 치매 (DLB)에 대한 최초의 치료법 개발에서 회사의 진전을 인정하는 것입니다. 회사는 12월 neflamapimod의 RewinD-LB 2b 임상 시험에 대한 주요 결과에 접근하고 있습니다. 2007년에 설립된 Prix Galien USA는 생명 과학 분야에서의 과학적 advances을 위한 미국의 주요 상으로 여겨집니다.
CervoMed (NASDAQ: CRVO) a été récompensée par le Prix Galien USA 2024 dans la catégorie Meilleure Startup, choisie parmi 43 nominés. Ce prix reconnaît les progrès de l'entreprise dans le développement du premier traitement pour la Démence à corps de Lewy (DLB), une condition touchant plus de 1,4 million de patients aux États-Unis et en Europe. L'entreprise approche des résultats préliminaires pour son essai clinique RewinD-LB de phase 2b sur le neflamapimod, prévu pour décembre. Le Prix Galien USA, établi en 2007, est considéré comme le prix le plus prestigieux d'Amérique pour les avancées scientifiques dans les sciences de la vie.
CervoMed (NASDAQ: CRVO) wurde mit dem Prix Galien USA 2024 in der Kategorie Beste Startup ausgezeichnet, ausgewählt aus 43 Nominierten. Der Preis würdigt die Fortschritte des Unternehmens bei der Entwicklung der ersten Behandlung für Demenzi mit Lewy-Körpern (DLB), einer Erkrankung, die über 1,4 Millionen Patienten in den USA und der EU betrifft. Das Unternehmen nähert sich den vorläufigen Ergebnissen der RewinD-LB Phase 2b klinischen Studie zu neflamapimod, die für Dezember geplant ist. Der Prix Galien USA, der 2007 ins Leben gerufen wurde, gilt als der wichtigste Preis Amerikas für wissenschaftliche Fortschritte in den Lebenswissenschaften.
- Selected as one of two winners from 43 nominees for prestigious Prix Galien USA 2024
- Developing first-ever treatment for DLB, addressing 1.4M patient market in US/EU
- Phase 2b clinical trial results expected in December 2024
- No approved treatment yet for their lead drug candidate
- Still in clinical-stage with no commercialized products
Insights
The Prix Galien USA award recognition, while prestigious, is primarily ceremonial and does not directly impact CervoMed's financial position or market value. The more significant catalyst lies in the upcoming December topline results from the RewinD-LB Phase 2b trial of neflamapimod for Dementia with Lewy bodies.
The target market is substantial, with over 1.4 million patients in the U.S. and EU currently lacking any approved treatment options. A successful trial outcome could position CervoMed as a pioneer in DLB treatment, potentially capturing a significant untapped market. However, investors should note that Phase 2b results, while important, would still require successful Phase 3 trials before any potential FDA approval.
The Prix Galien USA Best Startup category recognizes outstanding innovation by therapeutics-focused life science companies that have not yet received their first product approval
The award to CervoMed recognizes the advances made by the company towards developing the first treatment for Dementia with Lewy bodies (DLB)
BOSTON, Nov. 08, 2024 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical-stage company focused on developing treatments for age-related neurologic disorders, announced today it was awarded by the Galien Foundation the Prix Galien USA 2024 prize in the Best Startup category. Cervomed was selected as one of two recipients from a total of 43 nominees in the Best Startup category.
“DLB is a rapidly debilitating condition affecting over 1.4 million patients in the U.S. and EU, for which there is no approved treatment,” said John Alam, MD, Chief Executive Officer of CervoMed. “As we approach December and the availability of topline results for our innovative proof-of-concept RewinD-LB Phase 2b clinical trial of neflamapimod, we are honored to receive this prestigious prize in recognition of the scientific merit and advances we have already made in our clinical program. We believe our selection by a committee of prominent pharmaceutical industry leaders also implicitly recognizes the significance and major medical breakthrough that a positive outcome in the RewinD-LB study would represent.”
The Galien Foundation oversees and directs activities in the US for the Prix Galien, an international awards program dedicated to recognizing and honoring progress through innovative medicines development, with chapters in 15 countries. The Prix Galien USA is considered America’s preeminent prize acknowledging the leading-edge of scientific advances in the life sciences industry since 2007 (https://www.galienfoundation.org/prix-galien-usa).
Prix Galien Startup Awards Committee 2024
| Kenneth C. Frazier Committee Chair, Former Chairman & CEO Merck | Dr. Mikael Dolsten Chief Scientific Officer & President, Pfizer Research and Development | Penny Heaton Global Therapeutic Area Head, Vaccines, Janssen |
| Roch Doliveux Honorary CEO, UCB | Alex GORSKY Former CEO & Executive Chairman, Johnson & Johnson | Joel S. Marcus Executive Chairman & Founder, Alexandria |
| Sheri McCoy Board of Directors, AstraZeneca, Former CEO, Avon | François Maisonrouge Senior Managing Director, Evercore Partners | Elias Zerhouni Former Head of Global R&D, Sanofi |
About Dementia with Lewy Bodies (DLB)
DLB is the third most common degenerative disease of the brain (after Alzheimer’s disease and Parkinson’s disease), with approximately 700,000 individuals in each of US and EU. Patients with this disease accumulate protein deposits, called Lewy bodies, in the brain’s nerve cells. This negatively affects cognitive ability, including attention, judgement, and reasoning, along with motor function. Patients with DLB incur higher healthcare costs, have longer hospitalizations, report lower quality of life, and have caregivers with higher levels of distress when compared to patients with Alzheimer’s disease. No treatments for DLB have been approved by the U.S. FDA or 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 in DLB patients only transiently improves cognition and does not impact the motor component of the disease.
About Neflamapimod
Neflamapimod is an investigational, orally administered small molecule brain penetrant drug that inhibits alpha isoform of the p38MAP kinase. In preclinical studies, neflamapimod reversed synaptic dysfunction, including and particularly within the part of the brain most impacted in DLB – the basal forebrain cholinergic system. In Phase 1 and Phase 2 clinical studies involving more than 300 participants, neflamapimod has been shown to be generally well tolerated. Results from the AscenD-LB Phase 2a clinical study demonstrated that neflamapimod significantly improved dementia severity (assessed by Clinical Dementia Rating Sum-of-boxes, or CDR-SB) compared to placebo and significantly improved functional mobility (assessed by Timed Up and Go Test, or TUG test) compared to placebo. At the highest dose evaluated, neflamapimod also improved results on a cognitive test battery. The treatment response in AscenD-LB in patients with early-stage DBL (i.e., those without biomarker evidence of tau pathology in the brain) was substantial (effect size > 0.7) and greater than the overall patient population. Neflamapimod is currently being evaluated in Phase 2b study, named RewinD-LB, a randomized, 16-week, double-blind, placebo-controlled clinical trial in 159 patients with early-stage DLB. Patients completing the 16-week main study period are continuing in a 32-week open label treatment extension. The primary endpoint in the study is change in CDR-SB, and secondary endpoints include the TUG test, a cognitive test battery, and the Clinician’s Global Impression of Change. Topline data from RewinD-LB are expected in December 2024.
About CervoMed
CervoMed Inc. (the “Company”) is a clinical-stage company focused on developing treatments for age-related neurologic disorders. The Company is currently developing neflamapimod, an investigational, orally administered small molecule brain penetrant that inhibits p38 mitogen-activated protein kinase alpha. Neflamapimod has the potential to treat synaptic dysfunction, the reversible aspect of the underlying neurodegenerative processes that causes disease in DLB and certain other major neurological disorders. Neflamapimod is currently being evaluated in a Phase 2b study in patients with early-stage DLB.
Forward-Looking Statements
This press release includes express and implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, regarding the intentions, plans, beliefs, expectations or forecasts for the future of the Company, including, but not limited to, the therapeutic potential of neflamapimod and the anticipated timing and achievement of clinical and development milestones, including the completion and achievement of primary endpoints of the RewinD-LB Phase 2b clinical trial and the Company’s announcement of topline data therefrom. Terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “aims,” “seeks,” “intends,” “may,” “might,” “could,” “might,” “will,” “should,” “approximately,” “potential,” “target,” “project,” “contemplate,” “predict,” “forecast,” “continue,” or other words that convey uncertainty of future events or outcomes (including the negative of these terms) may identify these forward-looking statements. Although there is believed to be reasonable basis for each forward-looking statement contained herein, forward-looking statements by their nature involve risks and uncertainties, known and unknown, many of which are beyond the Company’s control and, as a result, actual results could differ materially from those expressed or implied in any forward-looking statement. Particular risks and uncertainties include, among other things, those related to: the Company’s available cash resources and the availability of additional funds on acceptable terms; the results of the Company’s clinical trials, including RewinD-LB; the likelihood and timing of any regulatory approval of neflamapimod or the nature of any feedback the Company may receive from the U.S. Food and Drug Administration; the ability to implement business plans, forecasts, and other expectations in the future; general economic, political, business, industry, and market conditions, inflationary pressures, and geopolitical conflicts; and the other factors discussed under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the U.S. Securities and Exchange Commission (SEC) on March 29, 2024, and other filings that the Company may file from time to time with the SEC. Any forward-looking statements in this press release speak only as of the date hereof (or such earlier date as may be identified). The Company does not undertake any 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:
PJ Kelleher
LifeSci Advisors
Investors@cervomed.com
617-430-7579
FAQ
When will CervoMed (CRVO) release RewinD-LB Phase 2b trial results?
What award did CervoMed (CRVO) win in 2024?
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