FDA News

Orphan drug status granted for therapy to prevent post-transplantation pancreatic islet loss

The FDA granted an orphan drug designation to Araim Pharmaceuticals for its Innate Repair Receptor activator ARA 290, according to a press release.

ARA 290 is intended for treatment to increase survival and improve function of pancreatic islets after transplantation.

“In an animal model, ARA 290 improved survival and function of the transplanted islets by 85%,” Michael Brines, MD, PhD, co-founder and chief scientific officer or Araim Pharmaceuticals, said in the release. “Increased survival of islets cells following transplantation has been the greatest challenge to successful outcomes for patients with severe type 1 diabetes. Protecting transplanted pancreatic islets from injury and subsequent loss underscores the potential beneficial role of Innate Repair Receptor Activiation in conditions associated with acute or chronic stress and inflammation.”

Recently published data from research at Karolinska Institutet in Sweden demonstrate that ARA 290 significantly improves the outcome of islet cell transplantation in an animal model of type 1 diabetes.

“Obtaining this orphan drug designation for ARA 290 is another important regulatory milestone in advancing our platform towards the patient,” Daiva Bajorunas, MD, chief medical officer of Araim Pharmaceuticals, said in the release. “This fourth orphan drug designation demonstrates the commitment of Araim Pharmaceuticals to prioritize and serve patients with critical unmet medical needs with our innovative Innate Repair Receptor platform. We are hopeful that improved transplant outcomes could become more widely available to the type 1 diabetic population with severe metabolic instability in need of additional treatment options.”

The FDA granted an orphan drug designation to Araim Pharmaceuticals for its Innate Repair Receptor activator ARA 290, according to a press release.

ARA 290 is intended for treatment to increase survival and improve function of pancreatic islets after transplantation.

“In an animal model, ARA 290 improved survival and function of the transplanted islets by 85%,” Michael Brines, MD, PhD, co-founder and chief scientific officer or Araim Pharmaceuticals, said in the release. “Increased survival of islets cells following transplantation has been the greatest challenge to successful outcomes for patients with severe type 1 diabetes. Protecting transplanted pancreatic islets from injury and subsequent loss underscores the potential beneficial role of Innate Repair Receptor Activiation in conditions associated with acute or chronic stress and inflammation.”

Recently published data from research at Karolinska Institutet in Sweden demonstrate that ARA 290 significantly improves the outcome of islet cell transplantation in an animal model of type 1 diabetes.

“Obtaining this orphan drug designation for ARA 290 is another important regulatory milestone in advancing our platform towards the patient,” Daiva Bajorunas, MD, chief medical officer of Araim Pharmaceuticals, said in the release. “This fourth orphan drug designation demonstrates the commitment of Araim Pharmaceuticals to prioritize and serve patients with critical unmet medical needs with our innovative Innate Repair Receptor platform. We are hopeful that improved transplant outcomes could become more widely available to the type 1 diabetic population with severe metabolic instability in need of additional treatment options.”