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Polish Subsidiary of San Antonio Firm Gets $4.6M for Endometriosis

Xconomy Texas — 

San Antonio — A subsidiary of Evestra, a San Antonio life sciences company focused on women’s health, has received a $4.6 million grant to develop an experimental drug for endometriosis, a painful condition related to overgrowth of tissue in the uterus.

Evestra Onkologia Sp., Evestra’s Polish-based subsidiary that’s focused on oncology therapeutics, is using the funding to push forward EC313, a treatment that’s a type of selective progesterone receptor modulator, or SPRM, Evestra says. Progesterone is a hormone that plays a role in the menstrual cycle when endometrial tissue lines the walls of the uterus, and endometriosis occurs when that tissue grows outside of the uterus, causing pain and potential fertility problems, according to the Mayo Clinic.

The exact cause of the condition isn’t certain, but companies like Evestra have been developing drugs that target progesterone receptors, which are in cells of endometrial and other tissue, in an attempt to control the condition. Evestra CEO Ze’ev Shaked says that most similar drugs are antagonists to the progesterone receptors—that is, they are aimed at inhibiting or blocking the receptors to potentially suppress things like the excess endometrial tissue. Antagonists have caused side effects, Shaked says, ranging from pain and nausea to bleeding and liver toxicity. In addition having antagonist activity, Evestra says EC313 has a component that also activates the progesterone receptors (partial agonist activity)—which Evestra says on its website may provide “extended and safe treatment” of endometriosis and other related diseases.

Drugs like EC313 “possess the right balance of agonistic and antagonistic ratio causing the best pharmacodynamics effect for a particular indication,” Shaked wrote in an e-mail about SPRM drugs. EC313 has an “on/off binding ability” to the progesterone receptor, Shaked says.

Other so-called SPRMs are being developed to target the disease and other women’s health conditions. That includes telapristone acetate, a treatment that Repros Therapeutics had placed on a clinical hold by the FDA for liver toxicity. The FDA lifted the hold in 2013, and Repros is now pushing for a Phase 3 trial in the U.S. That drug aims at selectively blocking the progesterone receptor. Ulipristal acetate (marketed as Ella in the U.S.) is another drug with both types of activity (antagonist and partial agonist) that is used as a contraceptive.

The grant funding came from the Polish National Centre for Research and Development and the European Union Regional Development Fund. Evestra’s Polish subsidiary will study the treatment in Lodz, Poland, after having already completed some preclinical analysis in vitro and in vivo, including in rats, according to Evestra and its subsidiary’s website. (The site was translated into English by Google.) The money should get the drug through Phase 1 and pay for the proof-of-concept work for Phase 2, Shaked says.

In early 2015, Evestra received a $5 million convertible loan from existing partner Gedeon Richter, which president and CEO Ze’ev Shaked said would be used to bring treatments for those conditions to clinical trials. Shaked says the company has taken money from partnerships, grants, and local investors (along with employees and friends), but hasn’t taken any venture capital funding. He declined to disclose how much in total Evestra has raised.

Evestra also has a vaginal contraceptive ring that would be a bioequivalent to NuvaRing that is in a pivotal study, EVE112, Shaked said at the time. Gedeon Richter, which is based in Budapest, Hungary, has licensed in EVE112 and one other product from Evestra, according to its 2015 annual report.

Evestra also received a grant from the Bill & Melinda Gates Foundation a year ago to research technology to make a long-lasting injectable fertility control for women in regions where there is little access to it. The amount wasn’t disclosed.