Eyeing Phase 2 Study of CNS Drug, Promentis CEO Plots Path Forward

Xconomy Wisconsin — 

Promentis Pharmaceuticals has for years publicly discussed its goal of commercializing a drug that uses a particular brain chemistry-regulating mechanism to treat central nervous system disorders. But it wasn’t until last week that the Milwaukee-based biotech revealed that the first clinical trial of its lead drug compound is aimed at treating trichotillomania, a chronic condition marked by hair pulling and hair loss.

It’s estimated that trichotillomania affects 1 to 4 percent of late adolescents and young adults, according to a 2011 paper in the journal Expert Review of Neurotherapeutics. The FDA has not approved any medications specifically designed to treat trichotillomania, says Promentis CEO Klaus Veitinger.

“Some have called trichotillomania the most prevalent disease you’ve never seen,” he says. “It’s very private and personal in nature. People do everything they can to hide it.”

The most common treatments for trichotillomania today include cognitive behavioral therapy and clomipramine (Anafranil), an antidepressant used to treat obsessive-compulsive disorder and other conditions, according to a 2013 paper published by Seminars in Cutaneous Medicine and Surgery.

Promentis’ lead drug candidate, SXC-2023, is designed to engage “system xc-.” That’s a molecular mechanism that transports two amino acids, cysteine and glutamate, into and out of neurons, in order to control brain chemistry.

“We are the first mover in this whole category of [system] xc-,” Veitinger says. “We want to preserve that lead. That’s why we kept … the indication under wraps until now.”

Trichotillomania is among a set of obsessive-compulsive and related neuropsychiatric disorders that glutamatergic imbalance and oxidative stress are believed to exacerbate, according to Promentis’ news release announcing that a Phase 1 study of SXC-2023 is underway. Another such disorder is dermatillomania, which involves scratching and picking at one’s skin, Veitinger says.

According to a website with information on the study, it is expected to enroll about 40 people. The study is aimed at assessing the safety of SXC-2023 in healthy patients, and is taking place in Tempe, AZ, Veitinger says. It kicked off on Sept. 11 and will likely conclude by the end of March, he says.

If all goes as planned, Promentis would then launch a larger, Phase 2 study of the drug in patients with trichotillomania in 2018, Veitinger says. Patients would be given different doses of SXC-2023 or a placebo, in order to evaluate the safety and effectiveness of the drug, he says.

Depending on the results the planned Phase 2 study produces, Promentis could begin developing drugs that use the system xc- mechanism to treat other disorders, Veitinger says.

“You [could] then talk about doing other studies for other indications, because you [will have] proved the principle of the xc- system” being used to treat certain neuropsychiatric disorders, he says. “Once you show the proof of concept, you open up all the other indications. The system has a broad range of potential applications. It [would be] a problem of riches.”

Earlier this year, Promentis completed a $26 million Series C round of financing. The company said last week that the proceeds from the funding round would likely allow it to advance SXC-2023 through a Phase 2 study.

In addition to his role at Promentis, Veitinger is also a venture partner at OrbiMed, a New York-based firm that invests in healthcare businesses, and which co-led Promentis’ latest financing. He has been a member of Promentis’ board of directors for several years, and agreed to join the company as CEO in late 2016.

Veitinger was previously CEO of Schwarz Pharma, a German company with operations in the Milwaukee area that was sold to Belgium-based UCB in 2006 for $5.6 billion. Another former Schwarz Pharma executive, Daniel Lawton, is a co-founder of Promentis and is currently chairman of the company’s board.

“I’ve followed this company for a long time,” Veitinger says of Promentis. “It’s a really exciting time, because this mechanism has been studied by academics for many years. This is kind of the first company driving into that space.”