Nasdaq GlobeNewswire

Aclaris Therapeutics Announces Positive Top-Line Phase 3 Results for A-101 In Treating Seborrheic Keratosis, a Common Undertreated Skin Condition

  • Pivotal Data Show Topical Treatment Delivered Statistically Significant Results, Meeting All Primary and Secondary Endpoints
  • Aclaris to Submit New Drug Application to FDA in 1Q17

Company to Host Conference Call Today at 5:00 PM ET

MALVERN, Pa., 2016-11-15 19:48 CET (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led clinical-stage pharmaceutical company focused on defining new standards of care in medical and aesthetic dermatology, today announced that two pivotal Phase 3 trials of its lead product candidate A-101 40% Topical Solution (A-101), a novel treatment for seborrheic keratosis (SK) met all primary and secondary endpoints of each trial, achieving clinically and statistically significant clearance of SK lesions.

The two trials, SEBK-301 and SEBK-302, enrolled 937 patients in total and were conducted at 34 centers in the United States.  The trials were identical in design and evaluated the safety and efficacy of A-101 compared to vehicle (placebo) in patients with four target SK lesions on the face, trunk and extremities.  Of the 937 patients enrolled, 467 patients received A-101 and 470 patients were administered placebo.  Investigators assessed the clearance of SK lesions using the validated four-point Physician Lesion Assessment (PLA) rating scale, which characterizes lesions as either clear (PLA=0), near clear (PLA=1), thin (PLA=2), or thick (PLA=3).  Patients in each trial had four target SK lesions, including at least one on the face and at least one on the trunk or extremities.  Each lesion received up to two treatments three weeks apart.  

Efficacy Results

Overall, results from the combined trials showed 51.3% of lesions treated with A-101 were assessed as clear or near clear (PLA<1) at trial completion versus 7.3% of lesions in the placebo group.  Notably, 65.3% of lesions on the face treated with A-101 were assessed as clear or near clear at trial completion versus 10.5% of lesions in the placebo group. 

The primary endpoint of both trials was the percentage of patients treated with A-101 who achieved clearance (PLA=0) of all four target SK lesions.  In the SEBK-301 trial, 4.0% of patients treated with A-101 achieved clearance of all four target SK lesions (p<0.002); in the SEBK-302 trial, 7.8% of treated patients achieved clearance of all four target SK lesions (p<0.0001).  None of the patients administered placebo achieved clearance of all four target SK lesions in either trial. 

The secondary endpoint of both trials was the percentage of patients treated with A-101 who achieved clearance (PLA=0) of at least three of the four target SK lesions.  In the SEBK-301 trial, 13.5% of patients treated with A-101 achieved clearance of at least three of the four target SK lesions (p<0.0001); in the SEBK-302 trial, 23.0% of treated patients achieved clearance of at least three of the four target SK lesions (p<0.0001).  None of the patients treated with placebo achieved this endpoint.  Clearance of three out of four target lesions is the primary endpoint that Aclaris has agreed upon with European Union (EU) regulators as a basis for approval.  Based on these results, Aclaris plans to submit a Marketing Authorization Application in the EU in mid-2017.

An ancillary endpoint was the mean per-patient percentage of target lesions treated with A-101 who achieved clear or near clear of all target SK lesions (PLA<1).  In SEBK-301, 47.5% of patients treated with A-101 achieved clear or near clear versus placebo which was 10.2% (p<0.0001).  In SEBK-302, 54.3% of patients treated with A-101 achieved clear or near clear versus placebo which was 4.7% (p<0.0001).

“I see many SK patients who lack confidence in their appearance, especially those who have lesions in visible areas such as the face and neck,” said trial investigator Zoe Draelos, M.D., board-certified dermatologist, fellow of the American Academy of Dermatology.  “For patients who seek to improve their appearance, a treatment that can achieve clearance or near clearance of lesions while delivering a favorable aesthetic result would represent a significant advance in the standard of SK treatment.”

SK lesions are common, non-cancerous skin lesions that impact more than 83 million Americans and frequently appear in highly visible locations such as the face or neck.  The lesions are typically characterized by a waxy, scaly, elevated appearance and can vary in color from light tan to dark brown or black.  SK lesions can have an adverse physical and emotional impact on patients.  Existing treatments are invasive, often painful, or have undesirable outcomes like scarring or dyspigmentation.

“We are extremely pleased by these top-line results,” said Aclaris President and Chief Executive Officer Dr. Neal Walker.  “We had a productive pre-NDA meeting with the U.S. Food and Drug Administration earlier this year and look forward to submitting a New Drug Application to the FDA in the first quarter of 2017.  We are committed to bringing this important new treatment to patients and their physicians.”  If approved, A-101 would be the first FDA-approved topical treatment for SK. 

Safety Results

There were no treatment-related serious adverse events among patients treated with A-101.  The most common adverse events were nasopharyngitis and sinusitis which were determined to be unrelated to A-101.  

Local skin reactions, if present, were predominantly classified as mild.  The rates of hypopigmentation, hyperpigmentation, and scarring classified as greater than mild were less than one percent in all groups in both trials.   

Additionally, Aclaris announced that initial safety results from an open-label safety trial of A-101 (SEBK-303) were consistent with the SEBK-301 and SEBK-302 trials.  The SEBK-303 trial enrolled 147 patients at 10 sites across the United States.

“This safety profile in these trials is compelling since there has been a significant need for an effective, non-invasive SK treatment without long-term pigmentary changes,” said Dr. Walker. 

Aclaris plans to present this data at a future medical meeting and also for consideration for publication in a peer-reviewed journal.

Management will conduct a conference call at 5:00 PM ET on November 15, 2016 to discuss these results.  The conference will be webcast live over the Internet and can be accessed by logging on to the “Investors” section of the Aclaris Therapeutics website,, prior to the event.  A replay of the webcast will be archived on the Company’s website for 30 days following the call.

To participate on the live call, please dial (844) 776-7782 (domestic) or (661) 378-9535 (international), and reference conference ID 21069052 prior to the start of the call. 

About A-101
A-101 (40% topical solution) is a proprietary, high-concentration hydrogen peroxide formulation in late-stage development for the treatment of seborrheic keratosis (SK). It is being developed as a non-invasive, in-office therapy, able to be administered by physicians or non-physician health care providers. In clinical trials, A-101 showed statistically and clinically significant results in clearing SK lesions with an adverse event profile similar to placebo. A-101 is designed to work by penetrating into the SK lesion and causing oxidative damage, which can ultimately result in the sloughing of the SK cells. A-101 has been the focus of a robust clinical development program in which over 700 patients have been treated with A-101. Aclaris plans to submit a New Drug Application (NDA) for A-101 in the first quarter of 2017. If approved, A-101 would be the first FDA-approved topical treatment for SK. A higher concentration of A-101 is also in clinical development for the treatment of common warts (verruca vulgaris). 

About Seborrheic Keratosis 
Seborrheic keratosis (SK) is a skin condition that affects more than 83 million Americans and is characterized by non-cancerous lesions with a waxy, scaly, slightly elevated appearance that can vary in color from light tan to dark brown or black. SK lesions frequently appear in highly visible locations, such as the face or neck, and can have an adverse physical and emotional impact on people who have them. SK sufferers may be affected with just one lesion or dozens and often have a family history of SK. Prevalence of SK increases with advancing age and over three-quarters of patients seeking treatment from dermatologists are aged 40 to 69. SK is one of the most frequent diagnoses made by dermatologists, yet it remains undertreated. There are currently no FDA-approved medications for SK, and existing treatment procedures are often painful, invasive and can have undesirable outcomes like scarring or dyspigmentation.

About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a clinical-stage dermatologist-led pharmaceutical company focused on identifying, developing and commercializing innovative and differentiated therapies to address significant unmet needs in medical and aesthetic dermatology. Aclaris is based in Malvern, Pennsylvania.

Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding Aclaris’ clinical development and potential commercialization of A-101 for the treatment of SK and common warts. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris' reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended December 31, 2015, Aclaris’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the “Financial Information” section of the Investors page of Aclaris' website at Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

         Aclaris Contact
         Michael Tung, M.D.
         Investor Relations
         Media Contact
         Mariann Caprino

Om Nasdaq GlobeNewswire

Nasdaq GlobeNewswire
Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

+1 212 401 8700

NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.

Følg saker fra Nasdaq GlobeNewswire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Nasdaq GlobeNewswire

Global Smart Lock Leader ASSA ABLOY joins Z-Wave Alliance Board of Directors12.12.2017 15:00Pressemelding

ASSA ABLOY takes a leadership role in the Alliance to help further Z-Wave adoption and to support global sales of Z-Wave Smart Door Locks FREMONT, Calif., Dec. 12, 2017 (GLOBE NEWSWIRE) -- The Z-Wave Alliance, an open consortium of leading global companies deploying the Z-Wave smart home standard, today announces the addition of ASSA ABLOY to the Alliance Board of Directors. Owner of leading and trusted lock brands such as Yale, Mul-T-Lock and ABLOY, ASSA ABLOY joins principal members ADT,, FIBARO, Huawei, Ingersoll-Rand, Jasco Products, LEEDARSON, LG Uplus, Nortek Security & Control, SmartThings, and Sigma Designs.  "ASSA ABLOY was already a leader in the smart lock industry and is clearly making moves to become a global force in smart security and connected access control," said Mitchell Klein, Executive Director of the Z-Wave Alliance, "The entire Alliance will benefit from ASSA ABLOY's contribution to the Board of Directors a

Ammo Incorporated Releases STREAK Visual Ammunition12.12.2017 15:00Pressemelding

SCOTTSDALE, Ariz., Dec. 12, 2017 (GLOBE NEWSWIRE) -- AMMO, Inc. (OTC:POWW), a technology leader and premier American ammunitions manufacturer, today announced its newest product offering, STREAK Visual Ammunition.  AMMO, Inc. holds the exclusive worldwide rights for the incredible patented technology used to make the STREAK products. STREAK is one of the most technologically advanced ammunition to hit the market in decades. "We are beyond excited to bring STREAK Visual Ammunition to the market.  Our acquisition of the exclusive rights for the STREAK technology is a game changer for both our company as well as the shooting industry.  Once you shoot with STREAK and you can actually see your projectile travel throughout its path, you will be bored by shooting normal ammunition," said AMMO, Inc.'s CEO, Fred Wagenhals. Unlike conventional tracers, STREAK rounds are NOT an incendiary, they don't use burning metals to generate light. Replacing fire-hazard burning metals is a non

Neato Appoints New CEO Matt Petersen12.12.2017 15:00Pressemelding

NEWARK, Calif., Dec. 12, 2017 (GLOBE NEWSWIRE) -- Neato Robotics, leader in smart robots for the home, today announced the appointment of new CEO Matt Petersen, effective January 1st, 2018. Petersen has sat on the Neato board since 2014. Petersen currently is the Senior Vice President and Chief Marketing Officer of JAFRA Cosmetics International, a Vorwerk owned subsidiary. A photo accompanying this announcement is available at Current CEO, Giacomo Marini, will step down after five years. Under his tenure, Neato has grown substantially and has launched innovative products with cutting edge technology, including the full Botvac Connected product line of robot vacuums. The tremendous amount of success during this period led to the acquisition by Vorwerk. Marini has been a Director at Neato since 2006, Chairman since 2007, Executive Chairman 2011-2013, and Chairman and CEO

Williams Scotsman to Acquire Acton Mobile12.12.2017 14:05Pressemelding

Expands Williams Scotsman's position as a specialty rental services market leader providing innovative modular space and portable storage solutions across North America Williams Scotsman will have nearly 100,000 modular space and portable storage units serving approximately 35,000 customers from over 100 locations across the United States, Canada and Mexico  BALTIMORE, Dec. 12, 2017 (GLOBE NEWSWIRE) -- WillScot Corporation (NASDAQ:WSC) ("Williams Scotsman") today announced that it has entered into a definitive agreement whereby Williams Scotsman International, Inc. will acquire the entity that owns Acton Mobile ( from Prophet Equity for a cash purchase price of $235 million, subject to customary adjustments.  Brad Soultz, president and chief executive officer of Williams Scotsman, commented, "We are excited to welcome Acton to the Williams Scotsman family.  Acton shares our core values, and is highly compl

Nature's Recent Scientific Reports Publication Describes How Apabetalone May Be a Powerful Agent Against HIV-112.12.2017 13:30Pressemelding

CALGARY, Alberta, Dec. 12, 2017 (GLOBE NEWSWIRE) -- Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) announced today that a recent Nature Scientific Reports has published a 12 page publication on BET (bromodomain and extra-terminal) inhibitors; RVX-208 (apabetalone) and PFI-1 owned by Resverlogix and Pfizer, respectively.  The publication by Lu et al, "BET inhibitors RVX-208 and PFI-1 reactivate HIV-1 from latency", (Scientific Reports 7, Article number: 16646, demonstrates that both BET inhibitors can reactivate HIV-1 from latency.  Persistent latent reservoirs of HIV-1 in resting CD4+T cells are the major obstacle in curing HIV-1 infection. Their conclusion suggests that BET inhibitors, such as apabetalone (RVX-208), are a group of leading compounds for potentially unmasking HIV-1 latency to allow for viral eradication. Mr. Donald McCaffrey, President and Chief Executive Officer commented, "We are thrilled to lear

ILPA Issues Model Subscription Agreement for Private Equity Funds12.12.2017 13:00Pressemelding

Fund Document Developed to Increase Clarity, Reduce Costs and Time to Close WASHINGTON and TORONTO, Dec. 12, 2017 (GLOBE NEWSWIRE) -- In an effort to streamline fundraising, increase clarity and improve the efficiency of capital formation, the Institutional Limited Partners Association (ILPA) today released a model subscription agreement (MSA) for private equity funds.  Developed by legal counsels representing the private equity industry, the modular, multi-jurisdictional document provides a balanced, off-the-shelf solution which can be easily customized to meet the needs of fund managers and their investors, saving significant time and cost.  The ILPA MSA is available to the industry on the ILPA website. "In speaking to private equity stakeholders about legal procedures in need of streamlining, the fund closing process was at the top of the list for constructive disruption," said Chris Hayes, Director of Industry Affairs, ILPA. "Both LPs

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom