New long-term analysis published in the Journal of Neurology, Neurosurgery & Psychiatry showed AMX0035 was effective at reducing a variety of harms associated with ALS during the previously published Phase 2 Centaur trial.
The ALS Association, in collaboration with ALS Finding a Cure, recently awarded $400,000 to support research into the role SARM1 gene mutations play in the development and progression of ALS, with the ultimate goal of using an improved understanding of SARM1 to develop new treatments.
Under the legislation, Minnesota will disperse $20 million to the Minnesota Officer of Higher Education to award competitive research grants to scientists studying the prevention, treatment, causes or cures of ALS. Applicants may range from research facilities, universities or health systems located in Minnesota. An additional $5 million will be dedicated to helping caregivers care for loved ones living with ALS. These caregiving funds will be appropriated to the Minnesota Department of Aging to fund local organizations dedicated to providing caregiver support programs that serve Minnesotans in their homes and communities. The funds may also be used to provide respite care.
Earlier today the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 6 to 4 against recommending AMX0035 for approval to treat people with ALS. It’s important to note that the Advisory Committee’s views are not binding on the FDA. Following the vote, the ALS Association called on the FDA to take into account the strong safety profile of AMX0035, as well as the serious unmet medical need of people living with this devastating condition, and approve the drug for clinical use.
The ALS Association, thanks to support from the Greater New York Chapter, has awarded $525,000 to four projects through its Milton Safenowitz Postdoctoral Fellowship program, which supports the development of new scientists in the field of ALS research.
Biogen and Ionis Pharmaceuticals have decided to discontinue research testing the investigational drug BIIB078 after a phase 1 clinical trial did not meet any secondary endpoints on efficacy and did not demonstrate clinical benefit.
“The Lawrence and Isabel Barnett Drug Development Program has fostered critical relationships between academia and industry and helped move the science forward. We are proud of the fact that projects supported by this program have leveraged that support to attract 6 more dollars for every $1 we initially invested,” said Dr. Kuldip Dave, vice president of research at The ALS Association.
The ALS Association announced today that it has awarded a $620,000 grant to the Packard Center for ALS Research at Johns Hopkins to support the Answer ALS Data Portal. Launched in January this year, the Data Portal provides open access to the world’s most comprehensive collection of ALS data.
Today, more than 230 organizations sent a letter to all 50 state governors urging them to maintain and expand licensure flexibilities enacted at the start of the pandemic for the duration of the federal public health emergency, to better address patient needs during the ongoing pandemic.
The ALS Association has created a new diagnostic guide, thinkALS, that will help neurologists more quickly diagnose ALS. Earlier diagnoses allow patients to participate in clinical trials and access treatments and benefits sooner, as well as receive care services support.
Following Amylyx’s announcement that it intends to submit a New Drug Application (NDA) for AMX0035, The ALS Association today urges the Food and Drug Administration to approve the treatment for all people with ALS as soon as possible.
The ALS Association today announced that California’s legislature, in conjunction with the California Department of Public Health has approved $15 million over the next five years for the wraparound model of care and treatment of ALS in the state.
Following the lack of action by the FDA to expedite approval of AMX0035, an experimental treatment for ALS, The ALS Association today called on the agency to follow its own guidance and move with the urgency of its Canadian and European Union counterparts. Health Canada and the European Medicines Agency (EMA) are working with Amylyx, the company that makes AMX0035, to move the treatment toward approval.
The ALS Association, Muscular Dystrophy Association (MDA) and ALS Finding a Cure® (ALSFAC), provided an additional $1.1 million in supplementary funding to leading investigators at the Houston Methodist Neurological Institute and Massachusetts General Hospital for promising research into cell therapy that could slow the progression of amyotrophic lateral sclerosis (ALS).
A press release outlining the certification that Holy Cross Health received as The ALS Association Florida Chapter's fifth multidisciplinary ALS clinic recognized as a Certified Treatment Center of Excellence