Posted by George Shaw on Oct 6, 2016
Reprinted with permission from aTyr Pharma
aTyr Pharma, a company engaged in the discovery and development of therapeutics to address severe rare diseases, is currently conducting two trials of Resolaris (ATYR1940) in patients with rare myopathies with an immune component:
Study ID |
Study Population |
Phase |
Study Design |
Dosing Regimen |
Duration |
ATYR1940-C-003 |
Early Onset FSHD Patient age 16 to 25 Symptoms before 10 |
1b/2 |
Open-Label, Intra-Patient Dose Escalation Study |
Weekly and twice weekly starting at 0.3 mg/kg with potential dose escalation up to 3.0 mg/kg |
12 weeks |
ATYR1940-C-004 |
LGMD2B and FSHD Adult Patients |
1b/2 |
Open-Label, Intra-Patient Dose Escalation Study |
Weekly doses starting at 0.3 mg/kg with potential dose escalation up 1.0 mg/kg and 3.0 mg/kg |
12 weeks |
The trials are designed to assess the safety, tolerability, immunogenicity and activity of Resolaris in patients with the muscular dystrophies of FSHD or limb-girdle muscular dystrophy 2B (LGMD2B or dysferlinopathies). Both trials are currently closed to new patients.
aTyr Pharma announced results from its first Phase 1b/2 trial in adult patients with FSHD. To review the press release, please visit the Press section at www.atyrpharma.com.
What is Resolaris (ATYR1940)?
aTyr Pharma is developing Resolaris as a potential protein therapeutic for patients with severe, rare mypotathies with an immune component, for which there are limited or no approved treatments. Resolaris is derived from a naturally occurring protein released in vitro by human skeletal muscle cells.
The Company believes Resolaris could potentially play a role in promoting skeletal muscle health by acting as an immunomodulator in skeletal muscle. Inflammation is believed to play a role in the disease process in FSHD and LGMD2B.
For additional information, please visit www.atyrpharma.com.
Where can I find more information on these trials?
Please visit the following websites to get more detailed information: www.clinicaltrials.gov (type ATYR1940 in “Search Studies”) and www.atyrpharma.com.
You can also contact aTyr Pharma by email at clinicaltrials@atyrpharma.com or phone at 1-877-215-5731.
Can I participate in one of these trials?
These trials are currently closed for new patients, but new trials may be implemented in the future. As soon as available, updates will be provided.
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