Propella Announces First Patient Dosed in Phase 1/2a Trial of PRL-02 for Treatment of Metastatic Prostate Cancer; Next-Generation Androgen Biosynthesis Inhibitor with Long Duration of Activity and Superior Therapeutic Index

PITTSBORO, N.C., June 29, 2021 – Propella Therapeutics, Inc. (“Propella”), a private, clinical-stage biopharmaceutical company developing best-in-class oncology therapeutics, today announced the dosing of the first patient in the Phase 1/2a clinical trial studying its lead patented product candidate, PRL-02 (abiraterone decanoate), for the treatment of metastatic prostate cancer.

The Phase 1 portion is an open-label, multi-center, dose-escalation study designed to assess the safety, tolerability, pharmacokinetics, and preliminary clinical activity of PRL-02 and establish a recommended dose for the phase 2a portion (NCT04729114).

“PRL-02 may provide improved bioavailability and convenience over the currently available therapies while also providing patients a potentially safer treatment option than the approved androgen biosynthesis inhibitors” said Dr. Robert Dreicer, Professor of Medicine and Urology at the University of Virginia. “I am personally intrigued by the PRL-02 profile and its potential to be a clinically meaningful new option for the treatment of patients with metastatic prostate cancer.”

According to William Moore, Propella Therapeutics President and CEO, “We are pleased to announce that the first patient has been dosed in the Phase 1/2a study evaluating our lead drug candidate, PRL-02, for the treatment of advanced prostate cancer. Propella’s core mission is to develop a robust pipeline of innovative therapeutics with significantly improved efficacy and safety for patients suffering from advanced forms of cancer by leveraging our expertise in medicinal chemistry and lymphatic targeting. We chemically engineered our next-generation androgen biosynthesis inhibitor, PRL-02, to avoid the high daily oral doses and hepatic safety warnings that appear on the label of approved abiraterone acetate products.  Based upon its long duration of activity and superior therapeutic index in preclinical models, we believe PRL-02 will significantly improve upon the current standard of care.”   

About Metastatic Prostate Cancer

Prostate cancer is the most common non-skin cancer in men, and the second leading cause of cancer death, developing most often in older men. Metastatic disease occurs when prostate cancer cells travel through the lymphatic system or blood stream to other organs and tissues such as lymph nodes, liver, bone, and lungs. While early or localized prostate cancer remains highly curable, advanced prostate cancer) remains difficult to treat, with a 5-year survival rate of only 30%. Although there are several treatment options for metastatic prostate cancer, the reduction of androgen activity remains the most effective approach.      

About PRL-02

PRL-02 is a next generation androgen biosynthesis inhibitor being developed for the treatment of prostate cancer. All androgen biosynthesis inhibitors approved for the treatment of prostate cancer block the CYP17 enzyme that is required for the biosynthesis of androgens, including testosterone. A large body of both historic and modern data support a role for androgens in prostate cancer pathogenesis and progression. PRL-02 is a patented prodrug of abiraterone designed for lymphatic targeting of tissues and tumors that express the CYP17 enzyme. PRL-02 is an intramuscular depot that, when given along with a gonadotropin releasing hormone agonist or antagonist, was engineered to precisely release the abiraterone needed to continuously block CYP17 enzyme for 3 months, while avoiding adverse liver and drug-drug interaction effects.

About Propella Therapeutics Inc.

Propella Therapeutics is a biopharmaceutical company that has developed a platform that combines lymphatic targeting with a medicinal chemistry optimization process to create best-in-class therapeutics to improve upon key limitations of known and proven cancer therapies. Propella is enrolling patients in a Phase 1/2a program studying its lead product candidate, PRL-02, for the treatment of metastatic prostate cancer. The privately held development-stage company, based in Pittsboro, N.C., is dedicated to meeting the needs of cancer patients currently underserved by existing standards of care.

Media and Investor Contact:

Brendan Griffin

bgriffin@propellatx.com

855-225-6378