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An expanded access program for the experimental treatment <a href="https://seelostherapeutics.com/sls-005-trehalose/" rel="nofollow">SLS-005</a> has dosed its first participant, according to <a href="https://seelostherapeutics.com/" rel="nofollow">Seelos Therapeutics</a>, the therapy&#8217;s developer.
The <a href="https://alsnewstoday.com/news/funding-expands-access-seelos-investigational-als-therapy-sls-005/">expanded access program</a>, or EAP, is an open-label study allowing access to SLS-005 for people with <a href="https://alsnewstoday.com/what-is-als/">amyotrophic lateral sclerosis</a> (ALS) who are not eligible for ongoing clinical trials, including an ongoing Phase 2/3 study of this potential therapy.
Conducted in collaboration with the Sean M. Healey &amp; AMG Center for ALS at Massachusetts General Hospital, the program expects to enroll about 70 adults who will be treated for six months. Contact information for the SLS-005 clinical program is available on a <a href="https://seelostherapeutics.com/healey-als-platform-trial-regimen-e-sls-005-trehalose/" rel="nofollow">Seelos webpage</a>.
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<h3>Trehalose in SLS-005 may help nerve cells to clear toxic proteins</h3>
&#8220;Initiating this EAP is an important event for Seelos and for patients in need of therapy who cannot participate in existing clinical trials,&#8221; Raj Mehra, PhD, chairman and CEO of Seelos, said in a <a href="https://www.prnewswire.com/news-releases/seelos-therapeutics-doses-the-first-amyotrophic-lateral-sclerosis-als-patient-with-sls-005-in-an-expanded-access-program-301788950.html">company press release</a>.
SLS-005 contains a naturally occurring sugar molecule called trehalose that is given as an infusion into the bloodstream. The therapy can enter the brain and is thought to promote autophagy, a recycling process used by cells to break down complex molecules they no longer need.
By activating this process, SLS-005 may help to clear the toxic clumps of proteins in nerve cells that are believed to help drive ALS. The therapy has been designated an orphan drug, a status that aims to incentivize the development of treatments for rare disorders, in <a href="https://alsnewstoday.com/news-posts/2020/11/20/fda-grants-orphan-drug-designation-to-seelos-sls-005-for-treating-als/">the U.S.</a> and the <a href="https://alsnewstoday.com/news-posts/2021/06/04/ema-orphan-drug-designation-sls-005-als/">European Union</a>.
SLS-005 is currently part of the <a href="https://clinicaltrials.gov/ct2/show/NCT04297683?term=HEALEY+ALS&amp;draw=2&amp;rank=1">HEALEY platform trial (NCT04297683)</a>, a clinical trial run by scientists at Massachusetts General to simultaneously test several potential ALS treatments against a shared placebo.
The trial&#8217;s <a href="https://clinicaltrials.gov/ct2/show/NCT05136885">SLS-005 arm (NCT05136885)</a> has <a href="https://alsnewstoday.com/news/enrollment-complete-als-phase-2-3-trial-sls-005/">finished enrolling 160 people</a> with ALS. Three-quarters of the participants are being treated with weekly injections of SLS-005, while the rest are getting weekly placebo injections. Its main goal is to assess whether treatment slows disease progression, as measured by changes in ALS Functional Rating Scale-Revised (ALSFRS-R) scores, and results are expected later this year.
The EAP is being conducted in parallel to the HEALEY trial, and it is funded by a grant from the National Institute of Neurological Disorders and Stroke (NINDS), given under the <a href="https://alsnewstoday.com/news/landmark-act-for-als-act-president-biden/">Accelerating Access to Critical Therapies for ALS Act</a> (ACT for ALS).
&#8220;We are grateful for the support from the ALS community, the Healey platform team and for the funding from NINDS,&#8221; Mehra said.
Seelos is also developing SLS-005 as a potential treatment for spinocerebellar ataxia (SCA), a genetic neurological disorder. The company recently announced, in a <a href="https://www.prnewswire.com/news-releases/seelos-therapeutics-announces-business-update-on-its-key-programs-301785089.html">separate press release</a>, that it is pausing enrollment of a clinical trial testing SLS-005 in SCA.
This decision was made purely due to business considerations, according to Seelos, and will allow more resources to be focused toward developing the therapy for ALS.

Tag: EAP

Expanded access program for SLS-005 begins treating first ALS patient