Start-up AFYX Applies Ultra-Sticky Patch Technology To Underserved Oral Mucosal Disease
Executive Summary
Emerging Company Profile: Patients with oral lichen planus suffer from painful lesions in the mouth that are hard to treat with topical steroids, leaving room for development of a new delivery method for the established clobetasol.
Start-up AFYX Therapeutics believes it has just the ticket for tough-to-treat mucosal diseases with its Rivelin patch technology platform, starting with oral lichen planus, which afflicts some 6m in the US and Europe.
Headquartered in Copenhagen and with a corporate office in San Diego, the company is focusing on developing topical treatments of a variety of generic drugs for patients with mucosal diseases, that is conditions affecting the mucosa lining body cavities, including the mouth and genitals.
The start-up formerly was called Dermtreat and targeted dermatological conditions, but it changed its name in 2018 to AFYX, a play on the word affix, to reflect a new specialized focus on drugs delivered by its proprietary patches for mucosal diseases with no approved treatment options.
The company's adhesive, biodegradable Rivelin patch – designed with its electrospinning technology manufacturing method – sticks well to wet surfaces, a feature it sees as differentiating.
"That is why we are focused on mucosal diseases, because we can deliver drugs to wet surfaces in a way that other technologies can't," CEO Nishan de Silva said in an interview at Biotech Showcase 2019 (see video).
AFYX's lead candidate RIVELIN-CLO delivers the corticosteroid clobetasol for treatment of the chronic inflammatory condition oral lichen planus, which afflicts about 1% of the population in the US and Europe combined, or 6m people in total. The active ingredient is well known and accepted, but de Silva says the company is applying the drug in a way that no one else has.
Nothing is approved for oral lichen planus, which causes painful lesions in gums and cheeks as well as on the tongue.
AFYX Therapeutics
-
Location: Copenhagen and San Diego
-
Founding Date: 2014 as Dermtreat, 2018 as AFYX
-
Founders: Jens Hanssen and Lars Hellerung Christiansen
-
Financing: Series A round of $17.7m in 2017 led by Sofinnova Ventures with Nordic venture capital firms Novo Seeds and Lundbeckfonden Emerge; previously raised $2m prior from range of investors R&D
-
Focus: Patch delivery of drugs on wet surfaces of the body
-
Disease area: Mucosal diseases, including oral lichen planus, vulvar lichen sclerosus
-
Patents: Technology platform and lead candidate patented through 2035, filed in Europe
-
Management team: Nishan de Silva (CEO); Lars Siim Madsen (COO); Martin Gormsen (VP, clinical development); Ann Christine Korsgaard (VP, regulatory affairs)
-
Board of Directors: Lars Ekman (Soffinova Ventures); Christian Elling (Lundbeckfonden Emerge); Kristine Peterson (Valeritas); Stephan Christgau (Novo Seeds); Jens Hanssen (co-founder, AFYX)
-
Clinical Advisors: Thomas Ruzicka (University of Munich); Richeal Ni Riordan (University College Cork, Ireland); Mike Brennan (Atrium Health of Charlotte, NC); Debbie Saunders (Health Sciences North of Sudbury, Canada); Richard Cook (King's College, UK); Vidya Sankar (Brigham and Women's Hospital of Boston); Donna Culton (University of North Carolina)
-
Employees: 9
Off-label steroid ointments and mouthwashes are available and are applied to the cheek, but are not easy to administer, due to bleeding ulcers and lesions all over patients' mouths, the exec said.
"The fundamental problem is you are not getting the drug to stay at the site of disease long enough to have an impact on the disease," he explained.
In a small Phase I study of 13 oral lichen planus patients, the mean adhesion time for a plain patch administered with no medication was 90 minutes, exceeding expectations, and the product was well-tolerated. Previously, in a small randomized study of 26 healthy volunteers, the plain patch exceeded the minimum objective adhesion times and was reportedly easy to use and easy to remove based on patient feedback, with no adverse events, the company reported.
To finance Phase II, the company raised $17.7m in Series A venture capital in mid-2017. The round was led by Sofinnova Ventures with Novo Seeds, an early-stage investment arm of Novo Nordisk Foundation, and Lundbeckfonden Emerge, the early stage investment unit of the Danish industrial foundation Lundbeckfonden.
A randomized, placebo-controlled Phase IIb study of 240 patients for the lead indication oral lichen planus is ongoing, with data expected in early 2020.
CEO de Silva described the ongoing study as very robust, noting that three strengths of the patch are being tested and several endpoints are being evaluated. After the data readout, the company will consult with regulatory authorities and determine how much of a capital raise it needs for Phase III, including private financing and/or an initial public offering.
Since nothing is approved for the indication, AFYX will be paving the way in terms of endpoints, de Silva said. In the Phase II study, reduction in ulcer size is the primary endpoint. (Also see "Pipeline Watch: Top-line Phase III Results For KX2-391, Dasotraline And Brigatinib" - Scrip, 30 Jul, 2018.)
Preparing For Solo Commercialization
AFYX is looking to take its lead product for oral lichen planus all the way through to approvals in the US and Europe, and to bring pipeline therapies forward behind that, on its own.
Oral lichen planus is a condition that is managed by a relatively narrow base of oral medicine specialist prescribers.
However, the company is always open to partnerships, de Silva said.
For the future, AFYX's Rivelin patch platform is flexible and usable for topical treatment of a wide variety of mucosal diseases, though the actual characteristics of the patches will change depending on the conditions.
The company is testing a Rivelin patch treatment with an undisclosed drug in a Phase I study of 12 patients with vulvar lichen sclerosus, a condition associated with patchy white skin on the vulva, and is expecting data this year. The condition often is misdiagnosed and patients may not come forward due to the lack of treatment options, but the available market research indicates there are 5m cases in the US and Europe, the CEO said.