The same trio of investors – Vivo Ventures, Fidelity Biosciences and Sofinnova Ventures – that lined up in 2012 behind a $21 million series A for Aclaris Therapeutics Inc. repeated the drill Thursday, plowing another $21 million into the company's series B with the goal of moving lead compound, A-101, to a new drug application (NDA) filing. (See BioWorld Today, Nov. 19, 2012.)

In June, the specialty pharma reported that the topical small-molecule drug showed clinically and statistically significant improvements in clearing seborrheic keratoses (SK), a common benign skin tumor, in a double-blind, placebo-controlled phase II study, with two additional phase IIb trials in SK ongoing.

The support of the company's three investors, all of whom have a board seat, was never in question.

"As a board and as a group we always want to make sure that the company is adequately capitalized to go all the way to an NDA approval process," said Neal Walker, president and CEO of Malvern, Pa.-based Aclaris. With the lead asset moving toward an end-of-phase II meeting in SK with the FDA, and with the company eager to advance A-101 in a second indication to treat common warts, "this seemed like the right time to make sure we had the necessary capital to keep going and not get distracted with financings."

Aclaris actually represents a second honeymoon for the principals, who first came together at Vicept Therapeutics Inc., which Walker co-founded with backing from the same syndicate. Vicept was developing a rosacea compound, then known as V-101, when the company was acquired in 2011 in a potential $275 million deal by Allergan Inc., which has moved the drug, oxymetazoline (AGN-199201) into phase III studies. (See BioWorld Today, July 20, 2011.)

With fresh capital under its belt, Aclaris plans to begin enrolling the phase III trial of A-101 in SK in the second quarter of 2015. Top-line findings are expected toward the end of next year, with an NDA filing by early in the first quarter of 2016.

The compound would represent the first topical treatment for SK, which represents one of the most common benign tumors in mature adults, typically appearing after age 40 and often running in families. Although painless, the lesions may become irritated and itch, and they often appear in unattractive clusters on the face, chest, shoulders and back.

Currently, SK lesions are treated using cryosurgery, electrosurgery, curettage or surgical removal – procedures that are painful and often result in changes in skin pigmentation or scarring at the treatment site. Use of a topical treatment would minimize or altogether eliminate those problems, Walker said, giving A-101 a differentiated profile in SK.

Although common warts often are treated topically, early evidence suggests that A-101 is more effective and causes less discoloration and scarring than existing treatments in that indication, as well, he added.

Aclaris has not disclosed the drug's mechanism of action or target.

Although its initial focus is the U.S., the company is taking a global approach to developing A-101, so studies are designed for multiple filings. In fact, the company already has met with regulators outside the U.S., Walker said.

To that end, Aclaris also is beginning to build a commercial team, with Kelly Copeland serving as vice president of product strategy. Copeland was vice president of commercial strategy for Ceptaris Therapeutics Inc. prior to its acquisition last August by Swiss drugmaker Actelion Ltd. Ceptaris developed a single asset, Valchlor (mechlorethamine) gel, which the FDA approved to treat stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma, a rare form of non-Hodgkin's lymphoma. (See BioWorld Today, Aug. 1, 2013, and Aug. 27, 2013.)

"Of course, we're always open to business development discussions," Walker told BioWorld Today. "Should the right partner and deal emerge, we'd entertain that. For now, we're focused on executing the plan."

The market has been active for pure dermatology plays, with one of the largest biotechs in the space, Dermira Inc., expected to price its initial public offering this week. (See BioWorld Today, Aug. 29, 2014.)

Others in the dermatology space include Anacor Pharmaceuticals Inc., of Palo Alto, Calif., which in July gained approval for its first drug, Kerydin (tavaborole), a topical antifungal to treat the common toenail and nail bed infection onychomycosis; Crescendo Biologics Ltd., of London, which is moving antibody technology into topical treatments for dermatological diseases; and Indian biopharma company Vyome Biosciences, which is developing treatments for skin conditions such as acne, persistent dandruff and bacterial and fungal skin infections. (See BioWorld Today, Dec. 12, 2013, July 9, 2014, and Aug. 18, 2014.)

Aclaris is the only company targeting SK with a topical product, according to Cortellis Competitive Intelligence. In part, that's because treatment for the condition is typically not reimbursed by payers.

Walker sees the lack of reimbursement as an asset rather than a liability. "The fortunate thing for our product is that it is positioned as cash-pay," he said. "With the evolution that's occurring in reimbursement, it's very attractive for physicians, in general, to have a product that doesn't have to wade through those issues."