A new pharmaceutical company has started up in Charlotte to develop and commercialize novel products for women’s health and urology.

Hammock Pharmaceuticals is using a novel drug-delivery technology to improve the effectiveness of traditional medicines for a variety of conditions, starting with bacterial vaginosis, a common infection caused by an over-abundance of bacteria in the vagina. More than 21 million women suffer from bacterial vaginosis in the U.S.

The company this month announced a license agreement with MilanaPharm and its sister company, TriLogic Pharma, of Tallassee, Ala., for exclusive global rights to their hydrogel technology. Hydrogel is a co-polymer that transforms from a liquid to a gel at body temperature, allowing it to adhere to body tissues.

When formulated with antibiotics or other active ingredients, the hydrogel can improve drug efficacy by staying in the body longer than traditional gels and creams.

Because its bio-adhesive property extends drug delivery from hours to days, the technology has the potential to transform the effectiveness and efficiency of active drugs including antibiotics, says Hammock CEO William R. Maichle. And because it’s not an oral formulation, systemic side effects are avoided.

Hammock’s two lead products for bacterial vaginosis are hydrogel-based formulations of metronidazole and clindamycin, two antibiotics that have been used safely in millions of patients for many years, but with limited results.

“We have to do a better job treating this disease,” Maichle says. “Women are hesitant to see their doctor because they’re embarrassed, but they need to understand they’re not alone. The fact is almost 30 percent of women of childbearing age in the US have bacterial vaginosis. And because our delivery technology is so innovative, we will be able to offer these women a one-dose treatment that’s nearly twice as effective as what’s on the market today.”

In a pilot study, Hammock’s clindamycin gel showed an 88 percent cure rate for bacterial vaginosis, significantly higher than the 40 to 60 percent cure rates of current treatments, Maichle says.

Hammock expects to begin a Phase 3 clinical trial of clindamycin and metronidazole gel formulations in the second half of 2017.

A misunderstood condition

If the formulations pan out, they could bring greater relief to the millions of American women aged 15 to 49 who suffer each year from bacterial vaginosis, the most common infection of the vagina. At least half the time, women with bacterial vaginosis have no symptoms, but those who do have symptoms typically notice an odorous discharge. Some patients experience itching.

According to the Centers for Disease Control and Prevention, bacterial vaginosis can increase a woman’s risk of contracting sexually transmitted diseases including HIV, and also increase the risk of premature deliveries in pregnant women.

“It’s unfortunate that bacterial vaginosis is so widely misunderstood and is almost an unmentionable subject,” Maichle says, explaining that it’s often mistaken for a venereal disease and can carry a stigma that keeps women from getting treatment and inhibits their social lives.

“We are confident that we have a better solution to help these women not only get back to their lives more effectively, but get there with a lot less disruption,” he says.

The gel formulations are intended to be a single-dose treatment given by a doctor or the patient using a pre-filled applicator similar to those used to insert tampons. The gel is bioabsorbable, meaning it eventually dissolves and is cleared from the body in urine.

Maichle says Hammock anticipates executing licensing agreements for the two formulations outside the United States in 2017. Patents for the hydrogel technology have been granted in the United States, the European Union and China, with additional patents pending that would grant exclusivity through 2035.

The annual global market for topical bacterial vaginosis treatments is estimated to be $300 million. Including the oral antibiotic treatments, the global market is over $500 million.

Pain-relief application

Hammock is developing another hydrogel formulation, called HPI-1216, for relief of pain caused by radiation cystitis, a frequent complication of radiation therapy for pelvic tumors or bladder cancer. Radiation treatments can damage the bladder, causing pain, frequent urination and other effects.

The active ingredient in HPI-1216 is lidocaine, a numbing agent that has been used widely to relieve pain since its discovery in 1946.

The formulation would be instilled in the bladder through a catheter. It would adhere to the bladder wall, where it would release lidocaine continuously “over days, and hopefully weeks,” Maichle says.

Hammock is working on a final formulation now and plans to begin a small clinical trial by the end of the year, he says.

Experienced management team

Maichle started the company in April 2016 after holding leadership roles at three other pharmaceutical companies.

“Hammock is my fourth start-up company in the bioscience industry, and it is definitely the one I’m most excited about,” he says.

Most recently he was president of Tribute Pharmaceuticals U.S., which merged with Chapel Hill-based Pozen to form Aralez Pharmaceuticals. Prior to that he was CEO of Nautilus Neurosciences before it was sold to Depomed. Previously he was chief operating officer of ProEthic Pharmaceuticals before it was sold to Kowa Pharmaceuticals.

Maichle, who has lived in Charlotte since 1999, says he chose to locate Hammock in the Queen City because of its “great healthcare system,” long roster of financial companies and deep hiring pool.

“Not only is Charlotte a great place to live and raise a family, it’s a perfect place to start a company,” he says. “There are so many talented, highly educated people living in our area, and that number is only increasing.”

Corie Curtis, executive director of the North Carolina Biotechnology Center’s Greater Charlotte Office, couldn’t agree more.

“We’re so delighted to add Hammock Pharmaceuticals to the growing life science community in the Greater Charlotte area,” said Curtis. “Our region is home to a diverse collection of biotech assets. At the Biotech Center we repeatedly hear domestic and international companies cite the region’s educated and increasing talent pipeline as a significant consideration in selecting Charlotte for location or expansion. Through collaborative effort, the Biotech Center is able to help foster an environment conducive to the successful growth of companies like Hammock.”

Maichle’s management team at Hammock includes three other executives with decades of experience:

  • Chief Operating Officer Terry Novak, who has 30 years of commercial and operational experience and was formerly COO of Pernix Therapeutics and an executive at DSM, Patheon, Alvogen/Norwich Pharmaceuticals and Innovex/QuintilesIMS.
  • Chief Financial Officer Frank Stokes, who has 20 years of experience in investment banking including managing director positions at Wachovia, Robert W. Baird and Co. and Leerink Partners.
  • Vice President of Marketing and Corporate Communications Laura Drew, who has 30 years of pharmaceutical and managed care experience, most recently at ProEthic/Kowa Pharmaceuticals.

Hiring, financing on horizon

Including the management team, Hammock has five employees and several consultants. It will hire more staff when this year’s clinical trials begin and as more commercial-stage products are added to its pipeline, Maichle says.

The company is financed by a recent convertible debt round funded by the management team and individual investors. Maichle says Hammock will embark on a Series A equity financing round in the next month or so.

The company is also in discussions with potential strategic partners in the U.S. and is looking for partners in other major global markets. New partnerships could attract more strategic financing than a typical equity or venture deal would bring, he says.

If Hammock in-licenses more commercial-stage products, it will likely turn to debt financing, Maichle says.

(C) N.C. Biotechnology Center