The study included three dose levels of Progenta as well as placebo and positive control arms. The positive control was Abbott’s Lucrin, an approved gonadotropin releasing agonist (GnRHa), commonly used for the treatment of fibroids.
After three months of exposure, the mean change in fibroid cross sectional area was 95% for placebo, 83.8% for 12.5mg Progenta, 64.9% for 25mg Progenta, 59.1% for 50mg Progenta and 62.5% for Lucrin. Both the 25mg and 50mg Progenta doses, as well as Lucrin, achieved a statistically significant reduction in mean fibroid size after three months compared to time zero.
The drug was well tolerated at all doses, with headaches being the most common adverse event to be reported over the course of the study.
Although the women in both the mid and high dose Progenta groups had fibroid reduction numerically equivalent to or superior to the GnRHa, Zonagen cautioned that this was a small study.
“This study represents an important first step in the development of Progenta,” noted Joseph Podolski, president and CEO of Zonagen. “Although the study was small, this early evidence suggests that Progenta, with a completely different mechanism of action than the GnRH agonists, may offer an alternative therapy that may not only be used preoperatively but may also offer the potential for chronic treatment to avoid surgery altogether.”
He further noted that the company has requested a pre-IND (investigational new drug) meeting with the FDA in preparation for submission of an IND.