Neurosense finalizing protocol for Phase 3 ALS trial of PrimeC
Dec 19, 2024 · In PARADIGM (NCT05357950), a completed Phase 2b study, PrimeC was tested against a placebo, both taken as two tablets by mouth twice daily for six months, in 68 adults diagnosed with ALS.Patients then had the option to enter an open-label extension where all received PrimeC for up to an additional 12 months. Consistent with earlier data, the 18-month readout showed that, compared with patients ...
Top 10 ALS news stories of 2024
Dec 30, 2024 · Read this story here. No. 8 – COYA 302 immune-modulating therapy shows promise in small early trial. Coya Therapeutics’ investigational therapy COYA 302 was found to slow ALS disease progression and lower levels of disease-related biomarkers in a small Phase 1 clinical trial. COYA 302 is a combination of an immune signaling molecule called interleukin-2 and a fusion protein called CTLA4-Ig ...
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Jan 17, 2025 · ALS Nexus 2025 event aiming to make disease ‘livable’ for patients. The ALS Association this summer will host the second edition of its ALS Nexus, a conference bringing together researchers, healthcare professionals, advocates, patients, and caregivers in a quest to make amyotrophic lateral sclerosis (ALS) a more livable disease.
Largest ALS patient-based stem cell, biodata resource now open
Nov 21, 2024 · The largest of its kind, the repository contains biological and clinical data from nearly 1,000 ALS patients, as well as specialized nerve cells called induced pluripotent stem cells (iPSCs) derived from the patients that scientists can use as a resource for advancing ALS research and treatment.. Researchers can access the resources via the online, open-source Answer ALS Neuromine Data Portal ...
Auttx gets ALS Network grant to develop new treatments for ALS
Nov 5, 2024 · Faster route to treatments for ALS. In ALS, certain proteins tend to form toxic clumps inside neurons and contribute to cell damage. A hallmark protein that’s dysfunctional in about 97% of all in ALS patients is TDP-43, which helps RNA inside the nucleus of cells to be appropriately processed.. When TDP-43 builds up outside the nucleus, it cannot perform its normal function.
Tiziana wins funding for small clinical trial in ALS of intranasal ...
Nov 22, 2024 · The upcoming trial intends to investigate the safety and effectiveness of two foralumab doses in 20 ALS patients. It builds on positive findings from multiple sclerosis (MS) patients, in whom the intranasal antibody therapy significantly decreased neuroinflammation and stabilized or reduced disability levels. Tiziana now wants to …
Initiative to use AI technologies to improve communication in ALS
Oct 17, 2024 · The Scott-Morgan Foundation (SMF), a nonprofit that’s pioneering assistive technology innovation, will lead a new initiative using artificial intelligence (AI) technologies to help people with diseases like amyotrophic lateral sclerosis (ALS) to better communicate and maintain their sense of identity.
Medicare plans told to cover Qalsody for ALS tied to SOD1 …
Dec 18, 2024 · The directive comes after the ALS Association worked closely with the CMS, presenting evidence of widespread instances where coverage was wrongly denied to patients who met all the necessary criteria for the treatment. According to the group, the order is the first of its kind to be issued by the center. Qalsody, an injectable treatment marketed by Biogen, was conditionally approved by the U.S ...
Clene granted in-person FDA meeting on CNM-Au8 for ALS
Sep 24, 2024 · Clene has been granted an in-person meeting with the U.S. Food and Drug Administration (FDA) — to be held before the end of November, according to the company — to discuss a potential accelerated approval of CNM-Au8 …
Neuvivo requests FDA approval of ALS treatment NP001
Oct 9, 2024 · The new drug application comes on the heels of combined data from Phase 2a (NCT01281631) and Phase 2b (NCT02794857) clinical trials, in which NP001 slowed disease progression and preserved lung function in a subset of ALS patients with high levels of inflammation.. If approved, NP001 could be the first disease-modifying therapy for ALS designed to restore the balance of the innate immune ...