King of Prussia, PA., May 23, 2017 Churchill Pharmaceuticals, LLC (Churchill) today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for YONSA™ (abiraterone acetate), an improved ultramicrosize formulation of abiraterone acetate. YONSA is a CYP17 inhibitor for the treatment of metastatic castration-resistant prostate cancer in combination with methylprednisolone. The submission is based primarily on the final results of the *STAAR Study, a randomized, open label patient trial comparing YONSA plus methylprednisolone, to another abiraterone acetate (Zytiga®) plus prednisone in metastatic castration-resistant prostate cancer patients (mCRPC). In a previous study of healthy volunteers, a dose of YONSA 500mg was found to be bioequivalent to a 1000mg dose of Zytiga.1
“Today’s submission marks an important milestone for Churchill and YONSA, opening a new potential future option for men with mCRPC,” said Scott Megaffin, President, Churchill.
YONSA is an investigational oral agent, formulated into tablets of abiraterone acetate ultramicrosize which are converted in vivo to abiraterone, an androgen biosynthesis inhibitor, that inhibits 17 α-hydroxylase/C17,20-lyase (CYP17). This enzyme is expressed in testicular, adrenal and prostatic tumor tissues and is required for androgen biosynthesis. YONSA Tablets ultramicrosize have double the bioavailability of the comparator formulation of abiraterone acetate. YONSA has been formulated using the SoluMatrix Fine Particle Technology™.
Prostate cancer is an androgen receptor dependent disease, and the blocking of androgen-receptor signaling is a hallmark of prostate cancer therapeutics. Although most patients initially benefit from therapy involving deprivation of gonadal androgen, the disease eventually progresses after 12 to 48 months, depending on the disease burden, host factors and inherent tumor biology. After progression, the disease evolves into a new state known as castration-resistant prostate cancer, which may progress to the metastatic stage and is invariably fatal.
The STAAR Study (CHL-AA-201, A Randomized, Open-Label, Active-Controlled, Multi-Center Study to Evaluate Serum Testosterone Levels in Patients With Metastatic Castration-Resistant Prostate Cancer) was an 84 day, open-label study comparing YONSA in combination with methylprednisolone against Zytiga® in combination with prednisone, in patients with metastatic castration-resistant prostate cancer. The primary endpoint was comparative lowering of total testosterone at pharmacokinetic steady-state. Additional secondary endpoints included safety assessments, PSA and pharmacokinetic measurements. The results of the STAAR Study will be released at a future scientific meeting.
YONSA™ (abiraterone acetate) Tablets ultramicrosize is also being evaluated in an extension protocol, the ^STAAR-E Study. The STAAR-E Study is evaluating the treatment of mCRPC patients over an extended period of time. This trial is an open-label, single-arm, multi-center study evaluating safety in patients taking YONSA (500mg qd) with methylprednisolone (4mg bid). Patients who successfully completed the 84-day treatment in the STAAR study on either YONSA or Zytiga® were eligible to enroll in the extension protocol for up to an additional 12 months of treatment with YONSA. Pharmacodynamic parameters of serum testosterone and PSA levels are being monitored.
For more information on these and other ongoing clinical trials of YONSA in mCRPC, please visit www.clinicaltrials.gov.
*STAAR: (Serum Testosterone in Response to AA Fine Particle (AAFP) in Metastatic CRPC)
^STAAR-E: (Serum Testosterone in Response to AA Fine Particle (AAFP) in Metastatic CRPC Extension Trial)
YONSA (abiraterone acetate) Tablets ultramicrosize, are not yet approved for any indication in any market.
Churchill is focused on providing value to cancer care by developing quality orally delivered oncology products with optimized clinical profiles. Our commitment to responsibly deliver these products to the patients, payers and healthcare communities we serve is at the core of our business.
For more information, please visit www.churchillpharma.com
iCeutica works with pharmaceutical partners, like Churchill, to create new branded medicines by combining our proprietary SoluMatrix™ Fine Particle Technology with our partners’ product experience and commercial insights.
The resulting products provide meaningful clinical benefits for patients and have clearly defined pathways to regulatory and commercial success. There are numerous FDA approved and late-stage products in development that utilize our SoluMatrix technology. SoluMatrix® is a trademark of iCeutica Pty Ltd.
Zytiga® is a trademark of JOHNSON & JOHNSON.
1 Relative Bioavailability of Abiraterone Acetate Fine Particle: Comparison of a Novel Formulation of Abiraterone Acetate vs. the Originator Formulation in Healthy Male Subjects: Two Randomized, Open-Label, Crossover Studies; Clinical Pharmacokinetics ISSN: 0312-5963 (Print) 1179-1926 (Online), Published Online, 19 April 2017