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 OMX
NASDAQ OMX (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra NASDAQ OMX
Registrer deg med din epostadresse under for å få de nyeste sakene fra NASDAQ OMX på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra NASDAQ OMX
XBiotech Announces First Patient in Study Evaluating MABp1 in Combination with Onivyde® and 5-fluorouracil/folinic acid for the Treatment of Pancreatic Cancer18.10.2017 16:53 | Pressemelding
AUSTIN, Texas, Oct. 18, 2017 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today enrollment of the first patient into a Phase I single arm study evaluating the maximum tolerated dose of Onivyde® (Irinotecan liposome injection) and 5-fluorouracil/folinic acid in combination with MABp1 in a cohort of patients with advanced pancreatic adenocarcinoma and cachexia. The patient has begun treatment at Cedars-Sinai Medical Center under the care of Dr. Andrew Hendifar, the Study's Principle Investigator, Medical Oncology lead for the Gastrointestinal Disease Research Group and Co-Director of Pancreas Oncology at Cedars-Sinai. A total of 16 patients are expected to be enrolled in the study. Dr. Hendifar commented, "We are excited to enroll our first patient in this novel combinatorial therapy for the treatment of advanced pancreatic cancer and cachexia. This is the first attempt to add an anti-inflammatory therapy to standard chemotherapy in an effort to improve the performanc
Nasdaq and SGX Establish Collaborative Listings Agreement18.10.2017 15:42 | Pressemelding
NEW YORK and SINGAPORE, Oct. 18, 2017 (GLOBE NEWSWIRE) -- Nasdaq Inc. (Nasdaq:NDAQ) and Singapore Exchange (SGX) today announced the signing of a collaborative agreement in a move to leverage their strengths as two of the leading listings venues in the U.S. and Asia respectively. The new agreement seeks to enhance the channels available for companies to access capital market funding and enhance their corporate profile in both markets. As part of this agreement, Nasdaq and SGX -- who also share a successful, long-term market technology relationship -- are currently exploring the demand among corporates for a concurrent or sequential listing on both exchanges. Nasdaq and SGX are committed to supporting companies that are interested in pursuing this route. "The business landscape today is borderless," said Loh Boon Chye, CEO, SGX. "Fast-growing Asian companies looking to tap the capital markets can choose to list on SGX on Asian home ground, and embark on a listing on Nasdaq
Colliers International Expands in Washington, D.C.18.10.2017 14:30 | Pressemelding
Acquisition of Beltway Real Estate Services Firm Strengthens Ongoing Commitment to the Region TORONTO and WASHINGTON, Oct. 18, 2017 (GLOBE NEWSWIRE) -- Leading global commercial real estate services firm Colliers International Group Inc. (NASDAQ:CIGI)(TSX:CIGI) announced today the acquisition of leading tenant representation advisory firm Serten Advisors. With its office in Tysons Corner, the firm serves global, national, and regional clients with a highly skilled and experienced team of professionals that have more than 100 years of combined experience. "This strategic acquisition positions Colliers to gain additional market share and win new business in the vibrant and competitive Suburban DC markets," said Marty Pupil, Colliers International President | U.S. Brokerage. "Adding Steve and Paul and the rest of their talented leadership team to our existing group of professionals in the region will further position Colliers as the commercial real estate services firm of
InSphero to Present Novel 3D Human Liver Fibrosis Model at Annual Liver Meeting® in Washington, DC18.10.2017 14:00 | Pressemelding
InSphero AG / InSphero to Present Novel 3D Human Liver Fibrosis Model at Annual Liver Meeting® in Washington, DC . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement. New 3D InSight(TM) Human Liver Fibrosis Model represents a powerful tool for screening efficacy and safety of anti-fibrotic drugs in vitro. Schlieren, Switzerland, Oct. 18, 2017 (GLOBE NEWSWIRE) -- InSphero AG, the leading supplier of assay-ready 3D cell culture models for accelerating drug discovery and development, will present data characterizing and demonstrating the utility of its new 3D InSight(TM) Human Liver Fibrosis Model for screening efficacy of anti-fibrotic drugs. The findings will be presented at oral and poster presentations this Friday at the annual meeting of the American Association for the Study of Liver Disease (AASLD) Conference in Washington, DC. Anti-fibrotic therapi
Kofax Wins "Most Innovative Solution for Banking Customer Authentication" Award for Third Consecutive Year18.10.2017 08:00 | Pressemelding
Grand Prix Banque & Innovation Honor Recognizes Kofax Mobile ID Customer Onboarding Solution and its Anti-Fraud Capabilities IRVINE, Calif., Oct. 18, 2017 (GLOBE NEWSWIRE) -- Kofax ®, a leading provider of software to simplify and transform the First Mile(TM) of business, today announced that Kofax Mobile ID(TM) has won "Most Innovative Solution for Banking Customer Authentication" in the 2017 Grand Prix Banque & Innovation Awards in Paris, France. Now in its fourth year, the Awards identify excellence and innovation in the banking sector. The program acknowledges technology companies that have launched and implemented the most outstanding banking-related software solutions, initiatives and projects in France over the past twelve months. This award highlights the new facial recognition and ID verificationfeatures of Kofax Mobile ID that determine the authenticity and validity of identification documents and their holders.
World Conference on Lung Cancer Wednesday Press Conference: PD-1/PD-L1 Advancements and Interventions to Prevent and Treat Lung Cancer18.10.2017 06:25 | Pressemelding
YOKOHAMA, Japan, Oct. 18, 2017 (GLOBE NEWSWIRE) -- The final press conference from the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer (WCLC) highlighted new advancements surrounding the discovery of PD-1 and PD-L1, including a discussion from the researcher credited with discovering PD-1, as well as interventions to prevent lung cancer and improve quality of life for lung cancer patients. Innovations in lung cancer treatment linked to the discovery of PD-1 Prof. Tasuku Honjo of Japan, who was the first to identify PD-1 in 1992, shared an update on how PD-1 blockers have been widely used to treat many types of cancers. After decades of study, research into PD-1 has led to breakthrough immunotherapy treatments that are being hailed as a "penicillin moment" in cancer treatment. "I believe that, just as a number of antibiotics developed in the wake of the discovery of penicillin now p
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom