Innovation out of decades-long research with a new anticoagulant target, Factor XIa
The name of this company, eXIthera, refers to its therapeutic aim, inhibiting Factor XIa, a new target that may offer a way to avoid the bleeding problems with current anticoagulants. Its lead drug, an injectable coded EP-7041, has completed a Phase 1 clinical trial in healthy human subjects and moved to a program in cardiac surgery using the heart-lung machine, where life-threatening clotting and uncontrolled bleeding are common. The company also has begun earlier-stage development of an oral Factor XIa inhibitor.
WHAT’S AT STAKE
The scientist who turns CEO and founder is now almost a stereotype in the biopharma industry. But in real life, many different paths can lead to the same destination. In a familiar tale, an academic researcher discovers a potential disease target, wants to turn it into a needed treatment, and starts a company, ideally with some good business advice. In the case of eXIthera, however, the cofounding scientist-turned-CEO, Neil Hayward, Ph.D., was an industry scientist who tumbled into business after he lost his longtime job with Daiichi’s U.S. research unit, when Daiichi merged with Sankyo in 2005. Yet, with the help of his boss at Daiichi, Hayward managed to secure the rights related to his work with a new anticoagulant target, Factor XIa, which the merging company no longer cared to develop.
The work on Factor XIa began with the knowledge that available anticoagulants prevent unwanted blood clotting, but also frequently produce uncontrolled bleeding. Factor XIa affects a major pathway that promotes clotting, and inhibiting it appears to cause no serious consequences, making it a strong anticoagulant prospect. Hayward already believed at least one molecule among 50 candidates would inhibit Factor XIa. That candidate, the 41st compound tested, is now eXIthera’s lead drug, EP-7041.
The new company was initially virtual, and, from his many years in the industry, Hayward knew he would need some reliable CROs and a lot of expert advice. He also knew exactly who he wanted to fill those roles. “Because I had worked for Daiichi, the investors said OK, we’ll take a chance on you,” Hayward recalls. “I’m a scientist. I am not a business guy. But I’m very opinionated about who I want to work with. I’ve been in America since 1993, so I feel as if I know the good, the bad, and the ugly. I’ve had very supportive investors, and I’ve had the right people around me to make sure we make very good decisions, and that’s what happened.”
Since its founding, eXIthera has remained quiet, biding its time, but this year, it was ready to greet the world. “I wanted us to generate good human data first, and we did. Now at the back end of a Phase 1, 60 people have taken our drug. It looks very safe, and we used a well-known coagulation biomarker, aPTT, which was elevated in treated patients, so we actually know the drug will work. We also know from other data that it works as an anticoagulant should. No clots, and no bleeding.” He adds that the drug stays in the blood, thereby avoiding risk to sensitive vital organs such as the liver and kidneys.
Hayward is an ex-Brit who is surprisingly loquacious for a career lab scientist. His natural affability serves him well, now that the company has come out of stealth mode. “Other companies are looking at XI now, and I’m raising serious money now to pay for a Phase 2. It is also raising the image of the company and getting out the message of why a Factor XI inhibitor should be a better drug.” From industry scientist to company founder/CEO, Hayward’s transition reflects the company he leads — rising out of deep experience and obscurity, unassumingly ready to make a big impression. No doubt they will.
Employees: 6 Headquarters: Westborough, MA
Finances Series A: $4M Series B: $14M
Research Partnership Funding
Sichuan Haisco in China for the Chinese IV (intravenous) rights to EP-704; $6M; grants Sichuan Haisco exclusive license to develop, manufacture, and market the drug for the Chisese IV sector
Latest Updates July 2018: FDA meeting to define path forward for EP-7041 post-phase 1, including Phase 2 designs