The study is the first to test the compound in humans and will compare the treatment to a placebo in healthy volunteers to assess its safety and tolerability, which is the trial’s main objective.
Participants will be split into six treatment groups that will receive one infusion each of increased doses of iMod.Fc or a placebo. Doses of iMod.Fc will range from 0.03 mg per kg body weight up to 5.0 mg/kg.
Participants will be monitored for 29 days after treatment for signs of adverse events.
Researchers will also assess how the drug is processed in the body — its concentration in the blood and how fast it is eliminated from the body — key information that needs to be gathered for all drugs in development.
iMod.Fc is a so-called physiocrine fusion protein, in which an antibody fragment has been linked to a physiocrine — a naturally occurring factor that aTyr believes is crucial for cell health by its involvement in protein production.
Several physiocrine proteins are produced from a single gene, according to the company’s research, which also discovered that the proteins are involved in immune modulating processes. aTyr calls this molecular signaling the Resokine pathway.
By fusing an antibody part to physiocrines, the company aims to improve the effect of the proteins. iMod.Fc is the first physiocrine fusion protein aTyr synthesized.
“The initiation of this study of iMod.Fc represents a significant milestone in the advancement of our programs … leveraging our understanding of the Resokine pathway to enter the clinic,” Sanjay Shukla, MD, MS, president and CEO of aTyr Pharma, said in a press release.
aTyr expects to have final results from the study by the second quarter of 2018.
“We look forward to announcing top-line results from this study in the second quarter of 2018, which we will use to guide our future development plans for iMod.Fc as we explore the potential of the Resokine pathway in restoring tissue homeostasis in patients with interstitial lung disease,” Shukla said.
Interstitial lung disease is an umbrella term used to define a complex group of pulmonary diseases, including sarcoidosis and idiopathic pulmonary fibrosis.
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