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The <a href="https://als.ca/">ALS Society of Canada</a> (ALS Canada) has awarded two expedited grants totaling $200,000 to international researchers seeking to advance understanding of <a href="https://alsnewstoday.com/what-is-als/">amyotrophic lateral sclerosis</a> (ALS).
Provided through the 2023 ALS Canada Acceleration Grant Program, a $100,000 grant will support Mónica Povedano, MD, at the Hospital de Bellvitge-IDIBELL in Barcelona, Spain, in conducting a population-based study of ALS in Colombia and Ethiopia.
Stefan Dukic, PhD, a postdoctoral researcher at the University Medical Centre Utrecht, in the Netherlands, will also receive $100,000 to develop a new method to subgroup people with ALS using an electroencephalogram (EEG), which measures the electrical activity in the brain.
“We are incredibly proud to be bringing forward an innovative opportunity to fund new projects at an expedited speed with the ALS Canada Acceleration Grant Program,” Tammy Moore, CEO of ALS Canada, said in a <a href="https://als.ca/blogs/als-canada-funding-new-acceleration-grant-program-2023/">press release from the non-profit</a>.
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<h3>ALS Canada seeks to fund research that will affect future discoveries</h3>
“ALS is a devastating disease; by bringing together global leaders in ALS to identify and support projects from around the world, we look to fund research that will change the outcome of an <a href="https://alsnewstoday.com/als-diagnosis/">ALS diagnosis</a> and have an impact on future ALS discoveries,” Moore said.
In ALS, the nerve cells that control voluntary movements, called motor neurons, progressively degenerate and die, preventing the brain from properly controlling muscles.
People with ALS experience <a href="https://alsnewstoday.com/symptoms-of-als/">symptoms</a> such as progressive muscle weakness, typically starting in the hands or feet, or the muscles around the throat and mouth, which leads to problems swallowing and speaking. Over time, muscle weakness can evolve into paralysis, with little to no ability to move or breathe. Eventual respiratory failure is the most common cause of death in ALS.
<h3>Program created to expedite funding process for promising research projects</h3>
The ALS Canada Acceleration Grant Program was created to expedite the funding process for promising research that relies on a unique form of global peer review. Specialists in the field take proactive measures to identify the most suitable projects to support rather than assessing applications after they are submitted. This could reduce the time to secure funding from years to a few months.
Among the selected projects, Povedano will lead a collaborative effort with colleagues in Colombia and Ethiopia to conduct an epidemiological study — the distribution of ALS in populations and the factors determining that distribution — in these countries. The project will be the first comparative study of ALS across different ethnic backgrounds while incorporating data from European individuals.
In addition, Povedano will help create the infrastructure to conduct clinical trials, which may provide access to <a href="https://alsnewstoday.com/experimental-treatments-for-als/">investigational therapies</a> in these countries. The research will also advance opportunities to discover new treatments that may help ALS patients globally if successful.
Dukic and colleagues have shown that EEG, which uses electrodes placed on the scalp, can detect abnormal patterns of brain activity related to motor and cognitive function in people with ALS. The technology may predict disease progression.
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<h3>Grant will help speed research, recruit more participants in EEG study</h3>
The grant will help speed up this work and recruit more participants. The team will also combine EEG with MRI to investigate individuals who carry mutations in the C9ORF72 gene, the most common <a href="https://alsnewstoday.com/als-and-genetics/">genetic cause of ALS</a>, and have yet to experience symptoms. This research may help the development of early or preventive treatments.
Funding for Dukic’s grant was made possible through a partnership with <a href="https://www.steviefever.com/">The Stevie Fever for ALS Foundation</a>, which contributed $100,000 to ALS Canada.
“Researchers around the globe are working tirelessly to uncover new discoveries that will advance our understanding of ALS and develop effective treatments for the disease,” said David Taylor, PhD, vice president of research and strategic partnerships at ALS Canada.
“To have an impact on people currently <a href="https://alsnewstoday.com/living-with-als-2/">living with the disease</a>, we must move faster to fund research and look at promising, innovative ideas beyond our borders to fuel discoveries that will lead to a world free of ALS,” Taylor added.

ALS Canada awards $200K to speed global disease research

Albrioza, the approved treatment for <a href="https://alsnewstoday.com/what-is-als/">amyotrophic lateral sclerosis</a> (ALS) formerly known as AMX0035, is one giant step closer to being eligible for reimbursement under public drug plans in Canada, according to its developer, Amylyx Pharmaceuticals.
<a href="https://www.amylyx.com/">Amylyx</a> has reached an agreement with the pan-Canadian Pharmaceutical Alliance, or pcPA — a government partnership in Canada that collaborates on various public drug plan initiatives — for terms under which ALS patients in the country can be reimbursed for Albrioza.
The negotiations began after the therapy, marketed as <a href="https://alsnewstoday.com/amx0035/">Relyvrio</a> in the U.S., was <a href="https://alsnewstoday.com/news/amx0035-oral-als-therapy-called-albrioza-approved-canada/">conditionally approved</a> by Canadian authorities a year ago. While Albrioza became <a href="https://alsnewstoday.com/news/amx0035-albrioza-oral-als-therapy-available-canada/">commercially available</a> in the country in August 2022, it hasn&#8217;t yet been listed on most public health plans — meaning patients on those plans couldn&#8217;t be reimbursed for its costs.
Amylyx has now signed off on its intentions to honor the new agreement in a letter of intent (LOI), which, if finalized, will enable eligible patients to avoid high out-of-pocket costs for the medication.
“Today marks a major milestone for people living with ALS and their caregivers in Canada. With this signed LOI, eligible Canadians living with this rapidly progressive disease who rely on public coverage are one step closer to accessing Albrioza,” Chris Aiello, general manager and head of Canada at Amylyx, said in a <a href="https://www.businesswire.com/news/home/20230615926630/en/Amylyx-Pharmaceuticals-Completes-Negotiation-Process-and-Signs-Letter-of-Intent-with-the-pCPA-for-ALBRIOZA%E2%84%A2-for-the-Treatment-of-ALS">company press release</a>, adding, however, “Our work is by no means done.”
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<h3>Advocates cite lengthy delay in getting treatment for ALS covered</h3>
With the LOI now in place, the company will move forward to work individually with federal, provincial, and territorial drug plans to finalize the agreements, which will enable Albrioza to be listed for reimbursement on those plans.
Although the news is welcome, some believe it did not come fast enough for patients, many of whom see rapid declines in the first few years after disease onset.
“While it is good news that Canadians living with ALS are closer to accessing this innovative treatment, some people living with ALS have been waiting a year to access this therapy, and they will continue to wait,” said Tammy Moore, CEO of the <a href="https://als.ca/">ALS Society of Canada</a>.
“People with ALS do not have the luxury of time,” Moore said.
[quote align=&#8221;center&#8221;]We believe there are opportunities to streamline the multiple steps and lengthy processes involved in achieving public reimbursement for treatments like Albrioza in Canada. The time is now for equitable and expedited access to approved treatments for ALS, and we will continue advocating on behalf of the ALS community to improve their access to care.[/quote]
The process of a therapy being listed on public health plans involves sometimes lengthy discussions between pcPA and the company that markets the therapy. The pcPA has to negotiate the price of the treatment on behalf of public drug payers, including both federal and local governments, along with determining which patients will be eligible for reimbursement.
Additional discussions then ensue with each individual public drug payer to work out the details.
“We believe there are opportunities to streamline the multiple steps and lengthy processes involved in achieving public reimbursement for treatments like Albrioza in Canada,” Moore said.
“The time is now for equitable and expedited access to approved treatments for ALS, and we will continue advocating on behalf of the ALS community to improve their access to care,” Moore added.
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<h3>Treatment for ALS facing regulatory hurdles in EU</h3>
Albrioza is a fixed-dose oral combination of two small molecules — tauroursodeoxycholic acid and sodium phenylbutyrate — that together are thought to protect nerve cells against forms of cellular stress implicated in ALS. As such, the therapy is expected to slow ALS progression.
Canadian authorities conditionally approved the treatment based on findings from the <a href="https://clinicaltrials.gov/ct2/show/NCT03127514">Phase 2 CENTAUR trial (NCT03127514)</a> and its <a href="https://clinicaltrials.gov/ct2/show/NCT03488524">extension study (NCT03488524)</a>. Their findings indicated that Albrioza significantly <a href="https://alsnewstoday.com/news-posts/2020/09/03/amx0035-safe-effective-in-slowing-als-functional-decline-trial-data-shows/">slowed functional declines</a> and <a href="https://alsnewstoday.com/news-posts/2022/05/06/amx0035-survival-als-patients-centaur-clinical-trial-analysis-amylyx/">extended survival time</a> for ALS patients.
A full, final approval in the country is contingent upon results from the global <a href="https://clinicaltrials.gov/ct2/show/NCT05021536">Phase 3 PHOENIX trial (NCT05021536)</a>, which is now seeking to confirm the benefits of Albrioza against a placebo in a larger group of patients. That trial, which <a href="https://alsnewstoday.com/news/phoenix-trial-approved-als-therapy-relyvrio-amx0035-enrolled/">completed enrollment</a> earlier this year, is expected to finish in 2024.
The therapy’s path to approval has not been as straightforward elsewhere.
In the U.S., it came under scrutiny by a U.S. Food and Drug Administration (FDA) advisory committee that initially voted that existing data <a href="https://alsnewstoday.com/news-posts/2022/04/01/fda-committee-votes-against-recommending-als-therapy-amx0035/">were not sufficient</a> to support the treatment’s clinical efficacy.
While that opinion is not binding, the FDA takes it into account when deciding about whether to approve a therapy.
Following a rare second review after Amylyx submitted additional trial data, the committee <a href="https://alsnewstoday.com/news/fda-committee-reversal-favors-amx0035-approval-als/">later reversed course</a>. The FDA ultimately <a href="https://alsnewstoday.com/news/relyvrio-amx0035-approved-us-als-treatment/">approved</a> the therapy, as Relyvrio, in September.
Now, the treatment faces similar hurdles in the European Union, where it&#8217;s under review. The European Medicines Agency (EMA)&#8217;s Committee for Medicinal Products for Human Use (CHMP) noted earlier this year that it was leaning toward <a href="https://alsnewstoday.com/news/amylyxs-als-therapy-amx0035s-facing-possible-no-from-chmp/">not recommending</a> the therapy for approval. In March, CHMP sought <a href="https://alsnewstoday.com/news/european-approval-amx0035-als-faces-new-hurdle-review/">more information</a> from Amylyx, noting there were still objections to the therapy that needed to be addressed.
As with an FDA advisory committee, the CHMP&#8217;s opinion is not binding, but will inform the final decision made by the EMA. The CHMP is expected to give its final opinion in coming days.

Tag: ALS Society of Canada

ALS Canada awards $200K to speed global disease research

Amylyx agrees to deal for Albrioza reimbursement in Canada for ALS