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.
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.
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, www.aclaristx.com, 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.
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 http://www.aclaristx.com. 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.
Michael Tung, M.D.
Om Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York
+1 212 401 8700http://www.nasdaqomx.com
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
Compuware Acquires XaTester and Partners with Parasoft to Deliver Essential Automated Unit Testing to Mainframe DevOps Teams18.7.2018 12:00 | Pressemelding
Topaz Further Established as the Leading Solution for Continuously Improving Velocity, Quality and Efficiency of Enterprise Systems Large enterprises must rigorously safeguard the quality of their mission-critical mainframe systems as digital demands drive them to develop and deploy mainframe code more quickly and frequently. With the acquisition of XaTester, new enhancements, and partnership with Parasoft, Compuware Topaz for Total Test is the clear leader in the automated unit testing essential for Agile and DevOps on the mainframe. With Topaz, developers at all skill levels can quickly and efficiently produce the highest-quality code for the mainframe-enabling enterprises to achieve the digital agility essential for success in fast-moving markets. DETROIT, July 18, 2018 (GLOBE NEWSWIRE) -- Compuware today announced a product acquisition, enhancements to Topaz for Total Test, and a partnership that together dramatically improve the ability of large enterprises to embrace Agile and De
Cryptomining Replaces Ransomware as Most Popular Cybercrime Malware18.7.2018 09:00 | Pressemelding
Analysis of vulnerability and threat trends shows cryptomining malware dominates threat landscape in the first half of 2018 SAN JOSE, Calif., July 18, 2018 (GLOBE NEWSWIRE) -- Skybox® Security, a global leader in cybersecurity management, announced today the release of its mid-year update to the Vulnerability and Threat Trends Report which analyzes vulnerabilities, exploits and threats in play. The report, compiled by the team of security analysts at the Skybox® Research Lab, aims to help organizations align their security strategy with the reality of the current threat landscape. The mid-year update explores trends observed from January to June of 2018. One of the most significant findings is the replacement of ransomware as the cybercriminal tool of choice with cryptomining malware. In the last six months of 2017, ransomware accounted for 32 percent of attacks, while malicious cryptominers accounted for seven percent. By the first half of 2018, the figures had switched almost exactly
GridGain® Continues In-Memory Computing Industry Leadership in 201818.7.2018 09:00 | Pressemelding
GridGain Continues Rapid Growth, Delivers Product Innovations, Hosts Vital Industry Conferences and Earns Top Industry Accolades FOSTER CITY, Calif., July 18, 2018 (GLOBE NEWSWIRE) -- GridGain® Systems, provider of enterprise-grade in-memory computing solutions based on Apache® Ignite(TM), today announced continuing strong momentum for the first half of 2018. Key achievements during the first half of the year included more new customer wins in the first half of 2018 than in all of 2017, launching major new products including GridGain Professional Edition 2.4 and GridGain Cloud, winning several top industry accolades, and driving continued growth of the popular In-Memory Computing Summit® in Europe. Growth New customer acquisition surged during the first half of 2018 with the company acquiring 40 percent more new customers than were signed in all of 2017. New customers acquired in 2018 include leading companies in financial services, transportation, telecommunications, retail, healthcar
ERYTECH Pharma Reports Voting Results from Annual General Meeting Held on June 28, 201817.7.2018 22:30 | Pressemelding
LYON, France and CAMBRIDGE, Mass., July 17, 2018 (GLOBE NEWSWIRE) -- ERYTECH Pharma (Euronext:ERYP) (Nasdaq:ERYP) announced that its 2018 Annual General Meeting was held in Lyon on Thursday, June 28, 2018. At the meeting, all resolutions for which management recommended a vote in favor, were adopted, including: - Approval of the annual financial statements and consolidated financial statements for the year ended December 31, 2017 and quietus of directors; - Allocation of the financial year's results; - Approval of regulatory agreements and commitments referred to in Article L.225-38 of the French Commercial Code; - Approval of the regulations of the share subscription and/or purchase options plan adopted by the Board of Directors on June 27, 2017; - Authorization for the Board of Directors to grant share subscription and/or share purchase options and/or to issue detachable share subscription warrants to corporate officers and employees of the Company or companies in the ERYTECH Pharma
Williams Scotsman Receives Competition Bureau Clearance for ModSpace Acquisition17.7.2018 22:15 | Pressemelding
BALTIMORE, July 17, 2018 (GLOBE NEWSWIRE) -- WillScot Corporation (NASDAQ:WSC) ("Williams Scotsman"), a specialty rental services market leader providing innovative modular space and portable storage solutions across North America, today announced that, on July 16, 2018, the Canadian Competition Bureau issued a No Action Letter relating to Williams Scotsman's proposed acquisition of Modular Space Corporation ("ModSpace"). WillScot has now obtained the regulatory approvals required to complete the acquisition and continues to progress towards closing in the third quarter of 2018. About Williams Scotsman Headquartered in Baltimore, Maryland, WillScot Corporation is the public holding company for the Williams Scotsman family of companies in the United States, Canada and Mexico. WillScot Corporation trades on the NASDAQ stock exchange under the ticker symbol "WSC." Williams Scotsman is a specialty rental services market leader providing innovative modular space and portable storage solutio
Minerva Neurosciences Elects Jeryl Hilleman to Board of Directors17.7.2018 22:05 | Pressemelding
WALTHAM, Mass., July 17, 2018 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced the election of Jeryl Hilleman to the Board of Directors of the Company. "Jeri brings a broad life sciences background to Minerva that includes high growth commercial biopharma, med-tech and data science companies," said William F. Doyle, Lead Independent Director of Minerva. "Her track record of delivering strategic and financial growth through execution, strategic partnering and multiple acquisitions will serve Minerva well as the Company completes five ongoing late-stage clinical trials with roluperidone, seltorexant and MIN-117." Ms. Hilleman is presently Chief Financial Officer of Intersect ENT (NASDAQ:XENT), a medical device company with commercial products for the treatment of chronic sinusitis. Previously, she served as CFO of several public
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom