Medicine that sticks
AFYX Therapeutics provides targeted drug delivery for mucosal diseases.
Lars Ekman, M.D., Ph.D.
Chairman, Executive Partner at Sofinnova Investments
ABOUT US
AFYX Therapeutics is changing the way mucosal diseases are treated. We are a topical drug delivery company developing a pipeline of targeted treatments for conditions that currently lack approved therapy options.
Our proprietary Rivelin® patch is flexible, biodegradable, and adhesive to mucosal surfaces. Designed with electrospinning technology, it delivers a therapeutic directly to the site in need, without interfering with patients’ daily activities.
Rivelin patches are compatible with a multitude of active pharmaceuticals, fueling our pipeline of products that seek to deliver relief through targeted, continuous therapeutic delivery to mucosal tissue. Our lead program, Rivelin-CLO, has completed Phase 2 for oral lichen planus, a condition that affects over 6M people in the US and Europe combined.
AFYX Therapeutics is creating a new treatment paradigm for mucosal diseases by providing the first medicines that stick.
Dr. Madsen brings more than 20 years of leadership experience in drug development and biotechnology, holding a range of key executive roles to advance new treatments. Prior to joining AFYX, he served as vice president and board member of pharmaceutical company NeuroSearch, which specialized in therapies for conditions affecting the central nervous system. Earlier, he held the role of chief operating officer at BioAdvice, a preclinical contract research organization. He holds a Ph.D. in molecular biology and immunology from the University of Copenhagen Faculty of Life Sciences.
For more than 25 years, Ms. Korsgaard has led biopharmaceutical regulatory functions in companies including Shionogi Europe, UCB, Genmab, Action Pharma, Actavis, and LEO Pharma. She’s served as the global regulatory lead on numerous projects and ushered companies through strategic, value-creating interactions with European, U.S., and Japanese regulatory authorities. Ms. Korsgaard’s expertise spans small molecules to biologicals, small to larger biopharma companies, and global regulatory filings across the spectrum of therapeutic development, from preclinical to post-marketing activities. In collaboration with Copenhagen University, she lectures for the Masters of Regulatory Affairs program on topics such as global regulatory strategy and clinical documentation for regulatory purposes. She holds a Master of Science in Pharmacy from the Royal Danish School of Pharmacy at the University of Copenhagen, and an MBA from the Scandinavian International Management Institute (SIMI).
Rivelin
Rivelin is a self-adhesive drug patch that’s designed to deliver uniform doses of a therapy to the mucosal lining, addressing a significant unmet need in the treatment of mucosal diseases.
Rivelin patches are developed using AFYX Therapeutics’ electrospinning process, which creates a unique dual-layer material composed of nanoscale and microscale fibers. The electrospun patch offers high porosity and surface area for drug bioavailability on the bioadhesive, biodegradable layer, enabling a sustained interaction with mucosal surfaces. The impenetrable backing of the second layer prevents drug loss into the oral cavity and drives drug penetration into the mucosa.
The result is a flexible, biocompatible, mucoadhesive patch that releases a therapeutic over a significant period of adhesion.
Publications
Rivelin-Clobetasol for Oral Lichen Planus
Phase 2 Clinical Results
In April 2020, AFYX Therapeutics announced that the Rivelin® Clobetasol patch (“Rivelin-CLO”) met the primary and multiple secondary endpoints in a Phase 2 study in patients with oral lichen planus (OLP). In the largest randomized, double-blind, placebo-controlled study ever conducted in OLP patients, the 20μg dose (Phase 3 recommended dose) of Rivelin-CLO demonstrated a statistically significant improvement in ulcer area, and continued to show improvement through the end of 4 weeks. No serious adverse events were observed and patients reported overall ease of use and patch adherence to the oral cavity for an average of 90 minutes.
Rivelin-CLO is the first biodegradable oral adhesive patch designed for local delivery of clobetasol to treat symptomatic OLP lesions. It uses a novel electrospinning technology to create a unique patch capable of adhering to the oral cavity for an average of 90 minutes, and other wet tissue surfaces for approximately 9.5 hours, while delivering a steady therapeutic dose to the lesion. OLP is a chronic, inflammatory disease characterized by symptomatic lesions and ulcers in the mouth, and is estimated to affect over 1 percent of the population in the United States and Europe, or over 6 million patients combined. There are no approved treatments for OLP.
The Phase 2 trial enrolled 138 adult patients diagnosed with OLP and who had at least one visible and measurable symptomatic ulcerative lesion. The study, conducted in Europe and North America, was a randomized, double-blind and placebo-controlled clinical trial with three active dose arms (Rivelin-CLO 1 μg/patch; Rivelin-CLO 5 μg/patch; Rivelin-CLO 20 μg/patch) and one placebo arm (Rivelin placebo patch). Patients were treated twice daily and evaluated on a weekly basis for 28 days of treatment.
Phase 1b Results
The second Phase 1 clinical trial, conducted in 2017, investigated adhesion time, tolerability and usability of the Rivelin plain patch in oral lichen planus patients. Thirteen patients were enrolled in the multi-center trial, and the patch was applied to OLP lesions on patients’ cheek, gingiva and tongue twice daily for four weeks. Patients were assessed weekly for adhesion time, tolerability and usability of the Rivelin patches. The minimum objective adhesion time was exceeded (with mean adhesion time of 90 minutes), and the patches were well tolerated with good patient compliance. The general patient experience with the Rivelin plain patches were positive, as assessed by patient questionnaire.
Phase 1 Results
The open-label, randomized (side to side) study in 2016 investigated adhesion time of the Rivelin plain patch in 26 healthy volunteers at three distinct locations within the oral cavity: cheek, gum and tongue. It also explored patient experience with applying the patch. Across all 78 adhesion events, the minimum objective adhesion time was met or exceeded. The patch led to no or minor irritation and low impact on speech and swallowing. All subjects noted no taste or weak taste with a neutral taste perception, and acceptability of the patch was high. Subjects noted the application process was easy and comfortable, and the patch was easy to remove. No adverse reactions were reported.
Rivelin for Vulvar Lichen Sclerosus
Phase 1 Clinical Development
In October 2019, AFYX announced results from a Phase 1 clinical proof of concept study evaluating the use of the Rivelin® bio-adhesive patch in patients with vulvar lichen sclerosus (VLS), a painful genital skin condition that affects up to 3% of post-menopausal women. All twelve patients in the study reported the successful self-application of the Rivelin patch to VLS lesions with a mean adhesion time of more than nine hours. No safety issues were reported and the patch was well tolerated. The poster presented at the 2019 EADV Congress is available on the publications page of the AFYX Therapeutics website.
Clinical Trials
Rivelin is currently being studied in mucosal diseases
where topical treatments have proven ineffective.
Rivelin-CLO for Oral Lichen Planus
Phase 2b
Conducted up to 20 sites in Europe and North America, the Phase 2b study is a randomized, double-blind, four-arm, placebo-controlled trial that will enroll approximately 240 adult patients clinically diagnosed with oral lichen planus and who have at least one visible and measurable symptomatic ulcerative lesion. The primary objective is to demonstrate the efficacy of three different doses of Rivelin-CLO patches in treating OLP lesions over four weeks, as assessed by change in ulcer area. Data is expected in 2019. More information is available at www.clinicaltrials.gov (identifier #NCT03592342).
Rivelin-Undisclosed for Vulvar Lichen Sclerosus
Phase 1
Our Rivelin product for Vulvar Lichen Sclerosus is being evaluated in a 12-patient, open-label single-center study in Denmark. Objectives of the Phase 1 study are to obtain patient feedback on feasibility of administering patch, to evaluate adhesion time on relevant regions of the body, to understand tolerability and sensation of the Rivelin plain patch, and to address what features a Rivelin vulvar patch should encompass. Based on the study results, further work is planned to optimize the patch in terms of size, shape, active ingredients, and adhesion profile. Data is expected by early 2019.
Oral Lichen Planus
Oral lichen planus, or OLP, is a chronic inflammatory mucosal disease that affects more than 1 percent of the general population — or more than 6 million people in the U.S. and Europe. Symptoms vary, but the disease is typically characterized by ulcerative lesions in the oral cavity, accompanied by inflammation and severe pain. The precise cause is unknown, although an autoreactive immune process is suspected. OLP cannot be passed from one person to another.
OLP is most frequently located on the buccal mucosa (the inside lining of the cheeks and floor of the mouth) but can also appear on the tongue, palate, gingiva, and lips. Because of the painful symptoms, which often arise during routine dental hygiene, and the long-lasting nature of the disease, patients require ongoing care and monitoring.
Patients with OLP have a higher frequency of transformation into oral cancer, up to 12.5%, making early detection and treatment imperative.
There are no approved treatments for OLP. Patients are currently treated with off-label steroids for managing painful, erosive, or bullous lesions. Yet, there are virtually no steroids formulated for topical drug delivery to lesions in the mouth. Creams and ointments do not adhere to oral mucosa and are easily swallowed, while mouthwashes and steroid inhalers have extremely short contact time with lesions. For severe and difficult-to-treat lesions, systemic steroids are often needed, even though OLP is localized.
AFYX Therapeutics is developing Rivelin-CLO as the first targeted treatment for OLP, delivering the powerful steroid clobetasol directly to the site in need.
For more information and support, please visit the International OLP Support Group.
Vulvar Lichen Sclerosus
Vulvar lichen sclerosus is a chronic inflammatory skin condition that most commonly affects the vulva, groin, and perianal region of postmenopausal women. Less frequently, it affects men and children, and it can develop in extragenital areas.
Symptoms may include itching (pruritus), discomfort or pain, smooth white spots, blotchy and wrinkled patches of skin, easy bruising or tearing, and, in severe cases, bleeding, blistering, or ulcerated lesions. The exact cause isn’t known, but the condition is not contagious.
Vulvar lichen sclerosus is often misdiagnosed or not diagnosed, sometimes due to patients’ reluctance to seek help. But research estimates a prevalence of approximately 5.3 million individuals in the U.S. and Europe.
Patients with lichen sclerosus have an increased risk of developing a cancer known as squamous cell carcinoma, making early detection and treatment especially important. However, there is no approved medical treatment for the condition. Off-label steroids, often in the form of creams or ointments, are standard of care today. Yet, these can easily rub off on clothing and do not remain securely at the lesion site.
AFYX Therapeutics is developing a flexible therapeutic patch that delivers powerful medication directly to the site in need, with the goal of providing a convenient and effective treatment to resolve vulvar lichen sclerosus as quickly as possible.
For more information and support, please visit the Danish VLS Society.
AFYX would like to hear from you.
Reach us at inquiry@afyxtx.com.
Headquarters:
European Union
Lergravsvej 57, 2. tv
2300 København S, Denmark
Corporate Office:
United States
12707 High Bluff Drive, Suite 200
San Diego, CA 92130
858-224-0062