Neurodevelopmental Disorders

Country’s Most Experienced Long-term Care Accountable Care Organization Shares $44.1 Million in Savings with Participating Providers Committed to Improving Quality and Cost of CareKENNETT SQUARE, Pa., Oct. 30, 2024 (GLOBE NEWSWIRE) -- LTC ACO, the first Accountable Care Organization (ACO) in the U.S. dedicated solely to long-term care facility residents, today announced it received a positive reconciliation and settlement under the Medicare Shared Savings Program (MSSP) for the 2023 performance year. As LTC ACO celebrates a decade in the MSSP, it anticipates significant growth, including expanding its services to assisted living facilities and continuing to lead in enhancing care for high-need populations. "We are extremely proud to announce that LTC ACO and our participating practices have once again achieved shared savings under the CMS Medicare Shared Savings Program, generating one of the highest savings rates on a per beneficiary basis in the country," said Jason Feuerman, president and CEO of LTC ACO. “Our positive results are a testament to the commitment of our participating providers, who work tirelessly to enhance care for the Medicare population living in long-term care facilities. We are grateful for the trust they place in us as their value-based care partner.” In 2023, LTC ACO attributed more than 16,000 Medicare fee-for-service beneficiaries to its MSSP ACO. The organization achieved total savings to CMS of nearly $60 million, resulting in earned shared savings of $44.1 million to LTC ACO. Since 2018, LTC ACO has saved Medicare more than $132 million demonstrating its commitment to cost-effective, high-quality care for long-term care facility residents. “As we enter our 10th year of MSSP participation, our mission remains focused on enabling the success of our partners in value-based care by providing innovative and effective insights and interventions,” said Feuerman. “Together with our partners, we will continue transforming healthcare quality for long-stay facility residents through industry-leading, value-based care solutions.” Leveraging its extensive experience, LTC ACO supports the value-based care success of providers serving patients in long-stay facilities. As an early adopter of CMS’s new quality reporting framework, LTC ACO continues to set higher standards in long-term care, pioneering advancements in health outcomes and reducing costs for long-term care residents. By leveraging innovative approaches, such as artificial intelligence for predictive analytics, LTC ACO enhances clinical analysis and reporting, helping our practices focus on their patients at greatest risk for avoidable hospitalizations to improve outcomes for its unique population of beneficiaries. LTC ACO focuses on a high need, underserved subset of the Medicare population. This includes the frail elderly, as well as individuals living with Alzheimer’s disease or dementia, depression, amputations, developmental or physical disabilities, renal failure and those with multiple chronic diseases and complications who reside in long-stay facilities. Over 85% of LTC ACO’s population is “dually” eligible, participating in Medicare and Medicaid. As the most experienced MSSP ACO serving practices treating these beneficiaries today, LTC ACO creates reliable shared savings revenue opportunities with no downside risk for its participating practices. To learn more about how LTC ACO helps providers and facilities achieve financial success and improve clinical impact in Medicare’s value-based care programs, visit http://www.ltcaco.com. About LTC ACOLTC ACO is the first Accountable Care Organization (ACO) in the United States dedicated to long-term care facility residents. LTC ACO began participating in the Medicare Shared Savings Program (MSSP) in 2016 for Medicare beneficiaries who reside in long-stay facilities. Visit http://www.ltcaco.com to explore opportunities for participation. Media Contact:Nerida Brennan610-925-1001

Phase 2b study will evaluate the safety and efficacy of gemlapodect (NOE-105) in patients with Tourette syndromeBASEL, Switzerland, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Noema Pharma AG, a clinical-stage neuroscience-based company, today announced the first patients have been dosed in a global Phase 2b study evaluating the safety and efficacy of gemlapodect (NOE-105) in Tourette syndrome. NOE-TTS-201 (NCT06315751) is a Phase 2b, 12-week, randomized, double-blind, placebo-controlled study that is designed to examine the safety and efficacy of gemlapodect. The trial will enroll 140 patients with Tourette syndrome in multiple centers in the US and Europe. Patients will be treated with up to 15 mg of gemlapodect once daily, or a matching placebo. The primary endpoint is the Yale Global Tic Severity Scale (YGTSS) Total Tic Score. “Patients with Tourette syndrome carry an incredible burden related to the expression of motor and vocal tics with limited treatment options,” said Ilise Lombardo, M.D., Chief Executive Officer of Noema Pharma. “I am happy to announce the progression of the development of gemlapodect in Tourette syndrome with the dosing of the first patients in our Phase 2b trial.” About Tourette Syndrome Tourette syndrome is a neurodevelopmental disorder in the wider spectrum of tic disorders, consisting of motor and vocal abrupt and brief movement or sound which is preceded by a local or generalized urge/premonitory sensation. TS impacts over a half-million individuals and families in the US alone, as well as millions of individuals worldwide. About NOE-105/gemlapodect NOE-105/gemlapodect is a potential first-in-class phosphodiesterase-10A (PDE10A) inhibitor in mid-stage clinical development as a dopamine modulator for Tourette syndrome. NOE-105 has been well-tolerated in studies with healthy volunteers and in patients with Tourette syndrome. NOE-105 has the potential to achieve a more targeted effect by modulating dopamine signaling exclusively in the medium spiny neurons of the striatum in the brain, while limiting off-target effects compared to other dopamine antagonists. About Noema Pharma Noema Pharma is a clinical-stage biotech company advancing a portfolio of transformative therapeutics utilizing first-in-disease approaches targeting neuroscience-based conditions with high unmet need. Noema has four programs currently in active Phase 2 clinical trials evaluating pain in Trigeminal Neuralgia, seizures in Tuberous Sclerosis Complex, Tourette syndrome and vasomotor symptoms plus associated symptoms of menopause with readouts expected in 2025. Noema was founded by leading venture capital firm Sofinnova Partners and is supported by current investors including Forbion, Gilde Healthcare, Invus, Jeito Capital, Polaris Partners and UPMC Enterprises. Learn more at www.noemapharma.com. Investor Contact: Precision AQAlex Lobo212-698-8802alex.lobo@precisionaq.com

Wholly owned first-in-class program anticipated to enter clinical trials in first half of 2025 THOUSAND OAKS, Calif., Oct. 30, 2024 /PRNewswire/ -- Capsida Biotherapeutics ("Capsida") today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Capsida for CAP-002. CAP-002 is the company's lead investigational gene therapy for the treatment of developmental and epileptic encephalopathy (DEE) due to syntaxin-binding protein 1 (STXBP1) mutations. CAP-002 is a novel, first-in-class IV-administered gene therapy using one of Capsida's proprietary engineered capsids designed to achieve brain-wide neuronal expression of the STXBP1 protein while significantly detargeting the liver. CAP-002 is currently in IND-enabling studies. "FDA's granting Orphan Drug Designation signals the significant potential that CAP-002 demonstrates based upon our preclinical data," said Peter Anastasiou, Chief Executive Officer of Capsida Biotherapeutics. "There are no disease-modifying therapies available for STXBP1 developmental and epileptic encephalopathy and CAP-002 could be the first, bringing hope for patients and families affected by this devastating disorder." The STXBP1 protein is present in every neuron in the brain and is essential for normal neurotransmission. A mutation in the STXBP1 gene is associated with treatment-resistant seizures, severe developmental delay and intellectual disability, motor abnormalities, and sudden unexpected death in epilepsy (SUDEP). Preclinical pharmacology studies have established the potential to treat and even fully correct the disease through gene supplementation. These studies demonstrated rescue of these neurological phenotypes was dependent on supplementation of STXBP1 in neurons throughout the brain at levels not achievable by wild-type serotypes, such as AAV9. Capsida conducted these studies with a proprietary murine disease model in collaboration with Mingshan Xue, Ph.D., associate professor of neuroscience and molecular and human genetics at Baylor College of Medicine, as well as a member of the Cain Foundation Laboratories and the Duncan Neurological Research Institute at Texas Children's Hospital. "Receiving Orphan Drug Designation moves us one step closer to our goal of transforming the lives of people living with STXBP1 developmental and epileptic encephalopathy," said Swati Tole, M.D., Chief Medical Officer at Capsida. "We are committed to advancing CAP-002, with our IND filing in the first half of 2025, and bringing novel gene therapies to people with high unmet medical needs." The FDA's Orphan Drug Designation is intended to encourage the development of treatments for rare diseases, defined as those affecting fewer than 200,000 people in the United States. Orphan Drug Designation may shorten the clinical development path through closer FDA collaboration and potential qualification for expedited development programs. This designation also provides the company with certain benefits, including tax credits for qualified clinical trials, exemption from user fees, and potential seven-year market exclusivity upon FDA approval. About STXBP1 Developmental and Epileptic Encephalopathy Developmental and epileptic encephalopathy caused by STXBP1 mutations is estimated to affect up to one in 26,000 children globally. It is associated with treatment resistant seizures, severe developmental delay and intellectual disability, motor abnormalities, and sudden unexpected death in epilepsy (SUDEP). There are no approved treatments. About Capsida Biotherapeutics Capsida Biotherapeutics is a fully integrated gene therapy company with a central nervous system (CNS) pipeline consisting of disease modifying and potentially curative treatments for rare and more common diseases across all ages. Capsida's intravenously (IV) administered gene therapies utilize proprietary engineered capsids that enable high transduction levels to desired tissues and cells, while limiting tropism to non-target organs, such as the liver. Capsida has three wholly owned programs, including a potential -first-in-class treatment for STXBP1 developmental and epileptic encephalopathy and a best-in-class treatment Parkinson's disease associated with GBA mutations, both of which are in IND-enabling studies and on track to enter the clinic in the first half of 2025. In addition to its wholly owned programs, the Company has validating CNS partnerships with AbbVie, Lilly, CRISPR Therapeutics, and the AbbVie partnership was expanded to include ophthalmology disorders. Capsida was founded in 2019 by lead investors Versant Ventures and Westlake Village BioPartners and originated from groundbreaking research in the laboratory of Viviana Gradinaru, Ph.D., a neuroscience professor at Caltech. Visit us at . SOURCE Capsida Biotherapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED