AFYX Therapeutics is changing the way mucosal diseases are treated. The company is developing a pipeline of targeted treatments for unmet medical needs in oral health diseases, such as Head and Neck cancer and Oral Lichen Planus; and women’s health diseases, such as Vulvar Sclerosus. Current treatments of mucosal and genital diseases involve the topical delivery of drugs using creams or mouthwashes, which is inefficient due to short exposure times of the site in need to the drug, or the systemic administration of drugs, potentially leading to significant secondary effects. In some cases, such as oral dysplasia, surgery may even be required to remove the affected area. The treatment paradigm developed by AFYX Therapeutics removes these disadvantages by targeting an effective dose of a therapeutic directly to the site in need, such as oral and genital mucosal surfaces, while avoiding systemic drug exposure. The composition of the patch makes it possible to achieve long adhesion times in multiple locations of the body (Up to several hours depending on the application site – e.g., 2 hours in the mouth and overnight on the female genitals).
The features of the patch help the patient to fully carry on with the treatment with a minimum of interference in their daily lives:
These benefits have been successfully proven in clinical studies, generating excellent Phase 2 data in Oral Lichen Planus and phase 1b data in Vulvar Lichen Sclerosus. The clinical trials have demonstrated to improve the patients’ quality of life. Additionally, the patch has been tested with a multitude of active pharmaceuticals, demonstrating the versatility of this technology. AFYX Therapeutics is creating a new treatment paradigm for mucosal and genital diseases by providing the first medicines that stick.
Produced using AFYX Therapeutics’ proprietary formulation and the electrospinning manufacturing technique, the Rivelin patch is comprised of two layers: an adhesive drug-delivery layer and a backing layer. The drug-delivery layer possesses a unique structure made of nanoscale and microscale fibers with high porosity and surface area, which facilitates patch adhesion to the mucosal lining. The adhesiveness of the layer only manifest when in contact with a moist surface, minimizing the risk of drug exposure elsewhere when handling the patch. The drug is incorporated into the fibers during manufacturing, and it is released after application to the site in need. This results in a prolonged interaction with the tissues and a sustained release, which enhances drug bioavailability.
The impermeable backing layer prevents drug release into any other areas than those intended and drives drug penetration into the target lesion. The backing layer also facilitates the easy application of the patch by the patient, for example by preventing the patch from sticking to the fingers. The result is a flexible, biocompatible, mucoadhesive patch that releases a therapeutic over a significant period of adhesion.
ORAL LICHEN PLANUS
Oral Lichen Planus (OLP) is a chronic autoimmune/inflammatory disease of the mucosa (the lining of the mouth, digestive tract, and genitals) that affects more than 1 – 2 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 asymptomatic reticular patterns but can also manifest in a symptomatic stage with open wounds (ulcerative lesions) in the mouth, accompanied by inflammation (erythematous) and severe pain. The precise cause is unknown, although an autoimmune disorder 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, the roof of the mouth, gums, 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, having a significant impact on the quality of life of the patients.
Patients with OLP have a significant risk of the lesions transforming 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, formulated for use elsewhere in the body, to manage painful, erosive, or bullous (with blisters) lesions. Yet, there are virtually no steroids on the market 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, steroids administered systemically with tablets or injections are often needed, which may give rise to undesired side effects even though OLP is localized. AFYX Therapeutics has developed a steroid patch as the first targeted treatment for OLP, which efficiently and safely delivers the powerful steroid clobetasol directly to the site in need thus reducing exposure of the drug to the rest of the body and minimizing potential side effects.
VULVAR LICHEN SCLEROSUS
Vulvar Lichen Sclerosus (VLS) is a chronic inflammatory disease that most commonly affects the mucosa in the vulva, groin, and perianal region of postmenopausal women, and less frequently it can develop in regions outside of the genital areas. In rare occasions, it can also affect men and children. VLS is not sexually transmitted and cannot be passed from one person to another. Symptoms may include itching (pruritus), discomfort or pain, smooth white spots, blotchy and wrinkled patches of skin, easy bruising or tearing. In severe cases, bleeding, blistering, or ulcerated lesions can also be seen. The exact cause is not known. VLS is often misdiagnosed or not diagnosed at all, sometimes due to patients’ lack of guidance on where to go for expert treatment. Research estimate that approximately 5.3 million individuals in the U.S. and Europe may suffer from VLS. Patients 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, formulated for use elsewhere in the body, are the standard of care today. Yet, these creams and ointments can easily rub off on clothing and do not remain safely at the lesion site for a long time.
AFYX Therapeutics has developed a flexible patch which efficiently and safely delivers a drug directly to the site in need. It has been clinically tested on patients for usability and comfort, and the feedback has been very positive. The patch provides a convenient and effective way to treat and heal the VLS lesions as quickly as possible.
HEAD AND NECK CANCER
AFYX has screened a new mode of action in an OncoPanel™ multiplexed cytotoxicity assay that measures multiple responses of cancer cell lines to drug treatments in parallel. This study evaluated the effect on human tumor cell proliferation, induction of apoptosis, and arrest of the cell cycle were measured. A summary of observations and results on oral cavity human tumor cell lines; Cal 27, SCC-25, SCC-4, SCC-9, A-253 concludes that AFYX has identified a new mode of action to target oral manifestations of Head & Neck cancer as the panel of test items inhibited proliferation, arrested cell cycle inhibition and induced apoptosis.
Meet the leader behind the success of AFYX Therapeutics
Lars Siim Madsen, PH.D. is the CEO of AFYX Therapeutics. 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.