In the Lab: Eppin Pharma

Posted | by Davis Rhodes |

Researchers Pioneering the Male Birth Control Pill

 

 Dr. Michael O’Rand has been on the cutting edge of reproductive technology since he pioneered in vitro fertilization in the 1980s. Now, his company is working on a non-hormonal birth control pill for men. Photo by Aramide Gbadamosi

 

In the lab at Eppin Pharma, researchers are hoping to create an alternative to traditional contraceptive methods: a male birth control pill.

Eppin Pharma is working on a pill that is taken orally and is effective for 24 to 96 hours. This would revolutionize the global contraceptive market, currently valued at over $19 billion, according to Dr. Michael O’Rand, Eppin Pharma president.

The pill could be taken daily. “Or men can take it just before they need it — like on a Friday night,” said Dr. Katherine Hamil, director of laboratory operations.

Research in Reproduction

O’Rand taught at the University of North Carolina for 35 years before co-founding Eppin Pharma in 2014.

“All of my research at the university was in reproductive biology,” O’Rand said. “That being studying sperm, spermatic genesis and all different aspects of reproduction, including fertilization.”

O’Rand established the in vitro fertilization laboratory at the UNC School of Medicine’s N.C. Memorial Hospital in the 1980s. He then turned to researching immunocontraception with support from NIH grant funding.

“Immunocontraception means developing an antibody that can be used as a contraceptive,” O’Rand said.

O’Rand and his team were searching for an antibody, which is a protein used by the immune system to neutralize, in this case, sperm.

“So Katherine (Hamil) and I, along with a variety of other researchers, were looking for new proteins that were only in the epididymis or testis — we were looking for specificity.”

Eppin

In 2001, O’Rand and his team published their first paper on the protein they called “eppin.”

Eppin stands for epididymal protease inhibitor, as this particular protein inhibits an enzyme that’s present in semen.

Their paper on eppin led to grant money from the NIH and the opportunity to begin testing on primates. Male primates immunized with eppin through an injection created antibodies to the protein and became infertile temporarily.

“This was a proof in principle that eppin was a good target, and that’s how we got started.”

Creation of Eppin Pharma

O’Rand retired from teaching at the university in 2014 to devote his time to eppin research and the founding of Eppin Pharma.

Along with Dr. Zahed Subhan and Dr. Jeffrey Handler, O’Rand founded the company with the mission of developing a non-hormonal male oral contraceptive.

Without knowledge of how to run a company, O’Rand leaned heavily on support from Carolina KickStart. KickStart assists young companies in reaching early milestones through funding and mentorship.

“I don’t think we could have done it without (Carolina KickStart),” O’Rand said.

The university provided Eppin Pharma with a Carolina Express License, allowing O’Rand and his team to operate out of his old laboratory on campus and expediting the research process.

“We had all of this startup funding directly as a result of being here at Carolina,” O’Rand said.

Switching from injections to the pill

Despite successful experiments involving injecting primates with the antibody, O’Rand and his team realized immunocontraception wouldn’t be seen as a practical birth control.

“Everybody responds to an immunization in different ways,” O’Rand said.

He started focusing on an oral pill rather than injections.

“We started looking for a substitute for the antibody,” O’Rand said. “Instead of having the antibody bind to eppin, we looked for something that was a small organic molecule that could substitute for the antibody and inhibit whatever eppin does.”

Sperm targeted by the drug “won’t swim,” according to O’Rand, using jazz hands to represent how the sperm stop swimming and vibrate in place.

This means that unlike other male contraceptive methods being researched, Eppin Pharma’s drug won’t affect the production of sperm. “You don’t affect any of the germ line, and you don’t affect any of the development of sperm,” Hamil said.

It also doesn’t protect against sexually-transmitted disease, making the target market committed couples.

Timetable

So when can couples expect to buy a male birth control pill? O’Rand can’t say for sure.

“They say, ‘Every year it’s 10 years away.’ Next year it will still be 10 years away, and that’s the standard answer for this business,” O’Rand said.

Eppin Pharma is in the “formulation” step in the research and development process. It is working with the Oregon National Primate Research Center to test the drug’s toxicology and effects.

“Over the next two or three years we will probably be able to go to the FDA for toxicology studies,” O’Rand said. “If we can surmount that hurdle without any toxicology problems we will be looking at clinical trials.”

Predicting how long FDA testing will carry on is almost impossible to predict because of the unique nature of the drug, according to O’Rand.

“Nobody has ever done this before,” O’Rand said. “So it’s not like they can just open the book and give us step one two and three. There is no pharmacological drug for male contraception — we just don’t know what to expect because we are pioneers,” O’Rand said with a grin.