A mix good news, bad news for Triangle biotechs: Dignify Therapeutics has secured $4.1 million in new funding from the National Institutes of Health. But Novan Therapeutics is mulling next steps after the FDA requires more data about its lead drug, an acne treatment.

Here are the details:

  • NIH provides $4.1M in funding for Dignify

Dignify has now secured $4.1 million in funding for its efforts in restoring bladder and bowel control for the elderly and for people with spinal injury, multiple sclerosis or diabetes, reports Barry Teater for the N.C. Biotechnology Center.

In 2015, Dignify raised more than $3 million in equity.

Federal funds have come. National Institute of Diabetes and Digestive and Kidney Diseases and the National Institute on Aging. The funding was awarded through the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, which help fund the commercialization of new innovations.

The latest grants support the development of Dignify’s lead therapy, DTI-100, intended to eliminate or reduce the need for life-long, multiple-daily catheterizations of the bladder and manual bowel programs.

“The DTI-100 program represents a series of related molecules that can produce on-demand, short-acting, drug-induced voiding for those individuals unable to voluntarily control voiding,” said Ed Burgard, Ph.D., president and CEO of Dignify. “The DTI-100 program is designed to produce voiding within minutes of dose administration, and be cleared from the body minutes later – a novel concept.”

Dignify is preparing for a Phase I clinical study of DTI-100, as well as studies to identify alternative formulations, through collaboration with the Division of Pharmacoengineering and Molecular Pharmaceutics at the UNC Eshelman School of Pharmacy. The clinical study could start as early as the first quarter of 2019 “with appropriate funding,” Burgard said.

Worldwide catheter sales total $3 billion per year, while health care expenditures associated with voiding dysfunction cost $7 billion per year in the United States, according to the company.

Dignify, a member of the Blackstone Entrepreneurs Network, is located in the First Flight Venture Center in RTP.

  • FDA requiring more testing for Novan’s lead drug

Meanwhile, on Monday the FDA said Monday it will require Morrisville-based Novan to conduct an additional clinical study of its proposed treatment of acne vulgaris.

“We had a productive guidance meeting with the FDA regarding SB204. The meeting provided important clarity with regard to design for any future pivotal trial,” interim CEO Kelly Martin said in a statement. “We intend to update the marketplace as to the next steps for SB204 after having had the chance to review and verify the final FDA minutes and incorporate that input into the overall Novan plan.”

The FDA’s decision is the latest setback for the company, reports Bryce Lapping for North Carolina Business News Wire.

In June, the company cut 20 percent of its workers and overhauled its executive team in a bid to turn around its fortunes. The Durham-based company said that it has enough cash to last it through the end of the year, but it will need more funding to successfully move its acne drugs, which use nitric oxide, through the approval process and get them to market.

In its 10-K for the 12 months ended Dec. 31, 2016, Novan warned shareholders of the possibility the acne-treating drug might not be approved.

The company has seen its stock fall from more than $27 per share to less than $10 per share, a mark it hasn’t moved above since.

Novan stock has fallen by more than 3.5 percent Monday, falling from $5.40 to $5.21 per share.