Hidden

Auritec Pharmaceuticals Completes Enrollment for its Sustained-release Depot Tacrolimus Clinical Trial

Santa Monica, CA

Nov 13, 2018

Auritec Pharmaceuticals Inc. ("Auritec"), a drug delivery company announced today the completion of recruitment of its investigational product (SR-TAC), for the prophylaxis of organ transplant rejection.

SR-TAC is a novel formulation of the commonly used immunosuppressive calcineurin inhibitor tacrolimus that is delivered subcutaneously. The product is an application of Auritec’s patented technology Plexis™, wherein microparticles are coated with biocompatible polymers to produce extended drug release at safe and therapeutic levels.

Tacrolimus is currently administered as daily pills that are known to demonstrate substantial inter-and intra-patient variability, dose-related toxicity and sub-optimal patient compliance, each of which contributes to graft failure especially in adolescent patients. Auritec’s SR-TAC formulation aims to minimize peaks and troughs and improved patient adherence that could lead to safer and more effective calcineurin inhibition.

RTB-010 is a single-center, first-in-human study to assess the safety and pharmacokinetic (PK) profile of SR-TAC, which will be administered as a single dose of 0.1 mg/kg by subcutaneous injection in eight healthy subjects between the ages of 18-45 years. Subjects will be followed for up to 60 days.

“The results from this study will inform the long-term goal of this program, which is to provide an improved treatment modality for prophylaxis of organ (kidney, liver and heart) transplant rejection with the additional benefit of enhancing medication compliance. These improvements have the potential to mitigate both the personal and economic burden of this disease,” said Auritec’s CEO, Dr. Thomas Smith. “Subsequent trials could lead to a product that improves adherence and reduces toxicity in transplant recipients.”

The trial is registered on www.clinicaltrials.gov as NCT03626714.

About Organ Transplantation

Each year more than 100,000 solid organ transplants are performed worldwide, and it is estimated that between 250,000 and 500,000 people are living with solid organ transplants requiring immunosuppression. The market for immunosuppressive drugs is estimated at greater than $4 billion. Global annual sales of tacrolimus products total more than $2 billion. Of the major players in the anti-graft rejection market, none have a sustained release formulation of their product.

About SR-TAC

SR-TAC is a first-in-class, sustained release, subcutaneous treatment for prophylaxis of organ transplant rejection. In SR-TAC, tacrolimus monohydrate (an immunosuppressive calcineurin inhibitor commonly used for prevention of transplant rejection in products such as Prograf®, Astagraf®) is coated with a biocompatible polymer to extend drug release. SR-TAC may also be used in the treatment of autoimmune diseases such as psoriasis.

About Auritec Pharmaceuticals, Inc.

Auritec is a privately held clinical stage drug delivery company with offices in Santa Monica, CA and a laboratory in Pasadena, CA. The company was founded in 2002 by Thomas J. Smith MD, the developer of the Vitrasert® ganciclovir intravitreal implant which was approved by the FDA in 1995. Since its incorporation, Auritec has been continuously funded by the National Institutes of Health, and has active programs in infectious diseases, autoimmune diseases, gynecology, cardiovascular disorders, pain management, and psychotic disorders. Auritec’s drug delivery technologies are covered by broad intellectual property protection and have demonstrated sustained-release drug delivery profiles for a broad range of molecules in vitro, and in animals and human trials.

For further information:

Sarjan Shah, Senior Director of Product & Business Development

Email: sshah@auritecpharma.com

Web: www.auritecpharma.com

Disclaimer

Research reported in this publication was supported by the National Institute of Allergy and Infectious Diseases (NIAID) of the NIH under Award Number U44AI069674. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.