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Posted Jan. 30, 2017 at 10:00 a.m.

Charlotte startup targets women’s health with novel drug discovery

Published: 2017-01-30 10:00:00
Updated: 2017-01-30 10:00:00

A brand new pharmaceutical firm has began up in Charlotte to develop and commercialize novel merchandise for women’s health and urology.

Hammock Pharmaceuticals is utilizing a novel drug-delivery know-how to enhance the effectiveness of conventional medicines for quite a lot of circumstances, beginning with bacterial vaginosis, a standard an infection brought on by an over-abundance of micro organism within the vagina. More than 21 million women endure from bacterial vaginosis within the U.S.

The firm this month introduced a license settlement with MilanaPharm and its sister firm, TriLogic Pharma, of Tallassee, Ala., for unique international rights to their hydrogel know-how. Hydrogel is a co-polymer that transforms from a liquid to a gel at physique temperature, permitting it to stick to physique tissues.

When formulated with antibiotics or different lively components, the hydrogel can enhance drug efficacy by staying within the physique longer than conventional gels and lotions.

Hammock PharmaceuticalsBecause its bio-adhesive property extends drug supply from hours to days, the know-how has the potential to rework the effectiveness and effectivity of lively medicine together with antibiotics, says Hammock CEO William R. Maichle. And as a result of it’s not an oral formulation, systemic unwanted side effects are prevented.

Hammock’s two lead merchandise for bacterial vaginosis are hydrogel-based formulations of metronidazole and clindamycin, two antibiotics which were used safely in hundreds of thousands of sufferers for a few years, however with restricted outcomes.

“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 research, Hammock’s clindamycin gel confirmed an 88 % remedy price for bacterial vaginosis, considerably greater than the 40 to 60 % remedy charges of present remedies, Maichle says.

Hammock expects to start a Phase three medical trial of clindamycin and metronidazole gel formulations within the second half of 2017.

A misunderstood situation

If the formulations pan out, they might deliver higher aid to the tens of millions of American women aged 15 to 49 that suffer annually from bacterial vaginosis, the most typical an infection of the vagina. At least half the time, women with bacterial vaginosis haven’t any signs, however those that do have signs sometimes discover an odorous discharge. Some sufferers expertise itching.

According to the Centers for Disease Control and Prevention, bacterial vaginosis can improve a lady’s danger of contracting sexually transmitted illnesses together with HIV, and in addition improve the danger of untimely 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 typically mistaken for a venereal illness and may carry a stigma that retains women from getting remedy 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 meant to be a single-dose remedy given by a physician or the affected person utilizing a pre-filled applicator just like these used to insert tampons. The gel is bioabsorbable, which means it will definitely dissolves and is cleared from the physique in urine.

Maichle says Hammock anticipates executing licensing agreements for the 2 formulations outdoors the United States in 2017. Patents for the hydrogel know-how have been granted within the United States, the European Union and China, with further patents pending that might grant exclusivity by means of 2035.

The annual international marketplace for topical bacterial vaginosis remedies is estimated to be $300 million. Including the oral antibiotic remedies, the worldwide market is over $500 million.

Pain-relief software

Hammock is creating one other hydrogel formulation, referred to as HPI-1216, for aid of ache brought on by radiation cystitis, a frequent complication of radiation remedy for pelvic tumors or bladder most cancers. Radiation remedies can injury the bladder, inflicting ache, frequent urination and different results.

The lively ingredient in HPI-1216 is lidocaine, a numbing agent that has been used extensively to alleviate ache since its discovery in 1946.

The formulation can be instilled within the bladder by way of a catheter. It would adhere to the bladder wall, the place it will launch lidocaine constantly “over days, and hopefully weeks,” Maichle says.

Hammock is engaged on a remaining formulation now and plans to start a small medical trial by the top of the yr, he says.

Experienced administration group

Maichle began the corporate in April 2016 after holding management roles at three different pharmaceutical corporations.

“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 just lately he was president of Tribute Pharmaceuticals U.S., which merged with Chapel Hill-based Pozen to type Aralez Pharmaceuticals. Prior to that he was CEO of Nautilus Neurosciences earlier than it was bought to Depomed. Previously he was chief working officer of ProEthic Pharmaceuticals earlier than it was bought to Kowa Pharmaceuticals.

Maichle, who has lived in Charlotte since 1999, says he selected to find Hammock within the Queen City due to its “great healthcare system,” lengthy roster of monetary corporations 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, government director of the North Carolina Biotechnology Center’s Greater Charlotte Office, couldn’t agree extra.

“We’re so delighted to add Hammock Pharmaceuticals to the growing life science community in the Greater Charlotte area,” stated Curtis. “Our area is residence to a various assortment of biotech belongings. At the Biotech Center we repeatedly hear home and worldwide corporations cite the area’s educated and growing expertise pipeline as a big consideration in choosing Charlotte for location or enlargement. Through collaborative effort, the Biotech Center is ready to assist foster an setting conducive to the profitable progress of corporations like Hammock.”

Maichle’s administration group at Hammock consists of three different executives with many years of expertise:

  • Chief Operating Officer Terry Novak, who has 30 years of economic and operational expertise and was previously COO of Pernix Therapeutics and an government at DSM, Patheon, Alvogen/Norwich Pharmaceuticals and Innovex/QuintilesIMS.
  • Chief Financial Officer Frank Stokes, who has 20 years of expertise in funding banking together with 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 expertise, most lately at ProEthic/Kowa Pharmaceuticals.

Hiring, financing on horizon

Including the administration group, Hammock has 5 staff and a number of other consultants. It will rent extra employees when this yr’s medical trials start and as extra commercial-stage merchandise are added to its pipeline, Maichle says.

The firm is financed by a current convertible debt spherical funded by the administration staff and particular person buyers. Maichle says Hammock will embark on a Series A fairness financing spherical within the subsequent month or so.

The firm can also be in discussions with potential strategic companions within the U.S. and is on the lookout for companions in different main international markets. New partnerships might appeal to extra strategic financing than a typical fairness or enterprise deal would deliver, he says.

If Hammock in-licenses extra commercial-stage merchandise, it’ll possible flip to debt financing, Maichle says.

(C) N.C. Biotechnology Center

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