Perle Bioscience’s Insulin Independence Revolutionary Phase III Trial

Perle Bioscience, Inc. recently announced enrollment for the Insulin Independence Trial (IIT). This trial is the first and only Phase III trial to test a combination therapy in type 1 diabetics. The end goal of the IIT will yield a medical breakthrough: insulin independence. The combination therapy will jumpstart the pancreas in type 1 diabetes patients so that the pancreas produces insulin and eliminates the need for insulin injections.

According to Dr. Claresa Levetan, Founder & Chief Scientific Officer of Perle Bioscience, “For patients with type 1 diabetes, the combination therapy patented by Perle Bioscience could end diabetes as we now know it. Our goal is to eliminate the need for patients with type 1 diabetes to receive insulin injections, and the mission of Perle Bioscience is to have this become a reality.”

PRL001, the combination therapy drug in the IIT sponsored by Perle Bioscience, combines the usage of an immune tolerance agent and a therapy for pancreatic beta cell regeneration. Each therapy is already FDA (Federal Drug Administration) and EMA (European Medical Agency) approved. Both classes of therapies have been used in more than 1,000 patients with new onset type 1 diabetes, but never used together. This novel therapy is expected to result in the ability of the pancreas to produce insulin with new beta cells protected from immune attack.

“The ultimate goal is insulin independence, which means type 1 patients go back to producing their own insulin from their own pancreas,” says Dr. Ryan Fiorini, President & CEO. “The success of this trial would result in a needle-free treatment, and will be life changing for those living with type 1 diabetes.”

The IIT launches in Europe, with the goal of US patient enrollment in a similar US-based trial based upon future FDA approval. Seven designated trial sites are located within Italy, with two additional sites to be scheduled outside of Italy. The lead trial site is in Rome at the Universita Campus Bio-medico di Roma, and will be conducted by the trial’s lead investigator Dr. Paolo Pozzilli. Perle Bioscience is a privately held research & development company. For more information, visit