PITTSBORO – Development-stage pharmaceutical startup Propella Therapeutics Inc. has just received a patent for its metastatic prostate cancer treatment, PRL-02.
The Pittsboro-based company develops off-patent medications into new therapies. It said the patent covers certain novel prodrugs. The body converts these biologically inactive compounds into the active pharmacological agent abiraterone.
Abiraterone is a powerful CYP 17 enzyme inhibitor that prevents the production of testosterone and other male sex hormones – or androgens – that feed prostate cancer cells.
Current treatments use abiraterone acetate. It’s taken orally on a daily basis and can result in the production of too much or too little abiraterone, according to Propella. The company said its new prodrug, abiraterone decanoate, has the potential to significantly reduce testosterone levels in men for three months after a single intramuscular injection.
Propella may also investigate PRL-02 as a treatment for other androgen-dependent diseases, according to President and CEO William Moore, Ph.D. The therapy currently is in late-stage preclinical testing for prostate cancer.
“This patent protects our ability to develop and market safe, effective and long-lasting drugs for the treatment of metastatic prostrate cancer and other conditions related to overproduction of androgens,” Moore said. “This protection gives Propella and its investors further confidence to complete promising preclinical studies and file its Investigational New Drug (IND) application in the first quarter of 2021.”
Propella was created earlier this year as part of a strategic reorganization of Maryland-based Vizuri Health Sciences, LLC. It currently has six employees.
The company focuses on finding and improving upon off-patent medications that are likely to qualify for the U.S. Food and Drug Administration’s 505 (b) (2) program. This pathway streamlines the development and authorization of new pharmaceutical products that use already approved active pharmaceutical ingredients (APIs).
The program reduces the need for improved APIs to duplicate earlier studies performed with the originator drug, which saves both developmental time and money. Therapies approved under 505 (b) (2) may qualify for five or seven years of market exclusivity in the U.S.
Propella currently has two other promising products in its development pipeline. Its flagship asset, CGS-200-5, is a non-opioid topical solution for osteoarthritis pain. The product s ready to begin phase 3 studies.
The company also has applied for a patent for another drug, PRL-01 for herpes virus infections. Like PRL-02, it is in late-stage preclinical testing.
(C) N.C. Biotech Center
Original Article Source: WRAL TechWire