AFYX Therapeutics AS

The preclinical study shows potential to deliver anti-TNFα antibody fragments to inflamed mucosal tissue using Rivelin technology Rivelin Patch shows superior results in preclinical study. (Credit: Chokniti Khongchum from Pixabay.) AFYX Therapeutics has unveiled positive results from a preclinical study, exploring the potential of its Rivelin patch technology in delivering antibody fragments. The study, conducted in collaboration with the UK’s University of Sheffield, evaluated Rivelin for delivering the antibody fragments directly to inflamed tissue to treat mucosal diseases. Rivelin is a mucoadhesive two-layered patch that delivers a pharmaceutical product directly to wet tissue surfaces. Leveraging a unique patch technology, Rivelin adheres to mucosal surfaces for long periods and facilitates uni-directional delivery of a pharmaceutical agent selectively to the target site. The patch is designed to limit the delivery of drug substances to areas surrounding the target site, enabling high efficacy, low dosing and less toxicity to non-affected parts. AFYX Therapeutics CEO Nishan de Silva said: “The recent presentation features the first Rivelin study demonstrating the potential to deliver not only small molecules but also proteins – in this case, anti-TNFα antibody fragments. “Delivering antibodies to target inflammatory disease in the oral mucosa using the Rivelin patch technology allows the development of new, locally-delivered therapies for mucosal diseases that currently can only be addressed with systemic treatment modalities. “Future studies will evaluate higher doses with potential to achieve complete neutralisation, and will aim to deliver anti-TNFα fragments topically to inflamed tissue in oral mucosal models.” In the study, the Rivelin patch was formulated with therapeutic anti-TNFα antibody fragments, where a biotinylated F(ab) fragment was electrospun into the existing Rivelin formulation. The results showed that the antibodies were delivered directly to inflamed mucosal tissue, while maintaining antigen-binding activity. Also, a low dose of anti-TNF F(ab)s reduced IL8 expression compared to placebo, showing that the F(ab) maintained neutralising activity on inflammatory cells, after release. AFYX said that the preclinical study, for the first time, showed that the Rivelin technology is capable of delivering biologic drugs. Also, the technology would significantly improve the treatment model for oral lichen planus and other inflammatory mucosal diseases. In a Phase 2 study, Rivelin-CLO 20-μg dose showed a statistically significant improvement in ulcer size in patients with oral lichen planus, a condition with no FDA approved therapy.

NEWARK, Calif., May 13, 2021 (GLOBE NEWSWIRE) -- CymaBay Therapeutics Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced that medical and clinical leader Dennis D. Kim, MD, MBA, is joining the company as Chief Medical Officer. “Improving patient lives is at the core of CymaBay’s mission, and Dr. Kim’s medical, clinical and strategic leadership – including his understanding of the rare disease community, passion for patient care, and a successful track record supporting fundraising, investor relations and industry partnership efforts – will help us do just that,” said Sujal Shah, CymaBay President and Chief Executive officer. “I’m thrilled to welcome Dr. Kim to our team and look forward to his leadership in advancing our current phase 3 program for seladelpar in PBC, as well as our pipeline of treatment options for liver diseases with high unmet need.” Dr. Kim has over 20 years of drug development experience most recently serving as Chief Medical Officer of clinical-stage biotech company Afyx Therapeutics, where he led clinical, medical and regulatory development for Rivelin, a novel mucoadhesive patch to deliver treatment for diseases such as oral lichen planus. In this role, he served as the company’s key representative in all external facing activities including business development, industry events and third-party initiatives. Prior to his role at Afyx Therapeutics, Dr. Kim served as Chief Medical Officer of Emerald Biosciences (now Skye Bioscience), where he focused on developing proprietary, synthetic cannabinoid-derived treatments for glaucoma and other diseases. Dr. Kim led preclinical and clinical research and development for THC-VHS for treatment of glaucoma and CBD-VHS for other eye diseases. Previously, he served as Chief Medical Officer of Zafgen, leading the company’s San Diego operations and clinical/medical affairs for development of its methionine aminopeptidase 2 inhibitor platform for metabolic diseases such as type 2 diabetes and rare genetic disorder Prader-Willi Syndrome. He has also counseled numerous pharmaceutical and biotech companies in advisory roles and as a Board member. “CymaBay’s talented team is poised to bring seladelpar to patients in need, and I am honored to join the company as it continues its phase 3 trials,” Dr. Kim said. “The opportunity to impact the quality of life for thousands of patients and their families is what drew me to CymaBay – and that includes the exciting and promising pipeline of potential therapies for patients with liver disease and advancing more options for people in need.” Earlier in his career, Dr. Kim held senior leadership roles at Orexigen Therapeutics, where he served on the company’s Joint Commercialization Committee in partnership with Takeda Pharmaceuticals for U.S. commercialization of weight-loss treatment Contrave; EnteroMedics, where he was a key member of the executive team leading the company’s initial public offering; and Amylin Pharmaceuticals, where he managed corporate and business strategic planning across all developmental drug candidates for treatment of diabetes and obesity, and oversaw corporate alliance partnerships. He has also served as an Assistant Professor and Chief Endocrine Fellow at the University of California, San Diego School of Medicine. Dr. Kim received his medical degree from The Chicago Medical School and completed his internal medicine residency at Rush University Medical College. He also holds a Master’s in Business Administration with emphasis in biotechnology structure and strategy from the University of California, San Diego Rady School of Business. He is a member of multiple professional societies, including the American College of Physicians, American Diabetes Association, American Association of Clinical Endocrinologists, and the Endocrine Society, and has authored more than 100 manuscripts, review articles and abstracts. Dr. Kim also serves on the Board of Directors for Inversago Pharma. About CymaBay Therapeutics CymaBay Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on improving the lives of people with liver and other chronic diseases that have high unmet medical need through a pipeline of innovative therapies. Our deep understanding of the underlying mechanisms of liver inflammation and fibrosis, and the unique targets that play a role in their progression, have helped us receive breakthrough therapy designation (U.S. Food and Drug Administration), PRIority MEdicines status (European Medicines Agency) and orphan drug status (U.S. and Europe) for seladelpar, a first-in-class treatment for people with primary biliary cholangitis (PBC). Our evidence-based decision-making and commitment to the highest quality standards reflect our relentless dedication to the people, families and communities we serve. To learn more, visit and follow us on Twitter and Linkedin. Cautionary Statements Any statements made in this press release regarding the future development of seladelpar or CymaBay’s pipeline programs, as well as statements regarding the completion of ongoing clinical trials are forward looking statements that are subject to risks and uncertainties. Actual results and the timing of events regarding the further development of seladelpar could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, which include, without limitation, risks related to: the success, cost and timing of any of CymaBay's product development activities, including clinical trials; effects observed in trials to date that may not be repeated in the future; any delays or inability to obtain or maintain regulatory approval of CymaBay's product candidates in the United States or worldwide; and the ability of CymaBay to obtain sufficient financing to complete development, regulatory approval and commercialization of its product candidates in the United States and worldwide. Additional risks relating to CymaBay are contained in CymaBay's filings with the Securities and Exchange Commission, including without limitation its most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. CymaBay disclaims any obligation to update these forward-looking statements except as required by law. Public Relations Contact: Glenn Silver Lazar-FINN Partners (973) 818-8198 Glenn.silver@finnpartners.com Investor Relations Contact: Hans Vitzthum LifeSci Advisors, LLC (617) 430-7578 Hans@LifeSciAdvisors.com

SAN DIEGO & COPENHAGEN--(BUSINESS WIRE)-- AFYX Therapeutics (“AFYX”), a clinical-stage biopharmaceutical company developing innovative approaches to treat mucosal diseases, today announced Phase 2 clinical efficacy and safety data of Rivelin® Clobetasol (“Rivelin-CLO”), a novel mucoadhesive patch designed to deliver clobetasol to lesions on wet tissue surfaces for the treatment of oral lichen planus (OLP). In this Phase 2 study investigating Rivelin-CLO across more than 20 clinical trial sites, a 20-µg dose resulted in a clinically significant reduction in OLP ulcer size, improvements in symptoms and quality of life, and a favorable safety profile compared to placebo – demonstrating its potential to address a significant unmet need in OLP. These data were presented during an oral session at the 2021 American Academy of Oral Medicine (AAOM) Virtual Annual Conference. “OLP is a chronic inflammatory condition causing agonizing mouth ulcers– and despite the continual pain and poor quality of life it inflicts on six million people in the U.S. and Europe, patients are left with no approved treatment options and rely on ineffective topical medicines,” said Michael Brennan, DDS, MHS, FDS RCSEd, professor and chair, Department of Oral Medicine at Atrium Health Carolinas Medical Center, and presenter of the study. “These data show the promise of a novel mucoadhesive clobetasol patch approach such as Rivelin-CLO to effectively treating these conditions that have remained overlooked for far too long.” This was the first and largest global, randomized, double-blind, placebo-controlled, efficacy and safety trial conducted in patients with OLP. In the study, 138 adults with symptomatic OLP and ≥1 measurable ulcers were randomized to 1, 5, 20 µg/patch doses or placebo in 1:1:1:1 ratio. Rivelin-CLO was applied daily for four weeks to visible and measurable symptomatic OLP lesions, and the study included a two-week follow-up after the end-of-dosing period. Patches were universally reported as easy to apply, remove, well tolerated and associated with high compliance. Most adverse events deemed to be related to treatment were mild, localized and did not result in study discontinuation. Statistically significant improvement in ulcer size at 20-μg dose The primary endpoint was the change in ulcer size versus baseline. The 20-μg treatment resulted in significant reduction in total ulcer area (‑45.0 mm2; p<0.05), symptom severity score (-2.967; p<0.001; 28-point scale), clinician’s severity assessment (-4.453; p<0.05; 106-point scale), and oral-mucosal disease-specific QoL (‑9.022; p<0.05; 104-point scale). The 1 and 5 ug/patch treatments showed positive impact but did not broadly reach significance. “Our Rivelin patch technology is designed to bring unidirectional, targeted drug delivery to one of the most difficult areas of medicine to treat: mucosal diseases,” said Nishan de Silva, M.D., CEO of AFYX Therapeutics. “With these clinically significant Phase 2 data in hand and a recommended go-forward dosage of Rivelin-CLO, there is the potential to finally deliver a treatment option that can benefit the OLP patient community. We look forward to continuing to advance the development of Rivelin-CLO.” A copy of the presentation, titled “Efficacy and Safety of a Novel Mucoadhesive Clobetasol Patch for Treatment of Oral Lichen Planus,” is available on AFYX’s website at . About Rivelin Patch Technology Rivelin is a muco-adhesive two layered patch that delivers a pharmaceutical product (such as clobetasol) directly to wet tissue surfaces. Rivelin utilizes a unique patch technology that adheres to mucosal surfaces for extended periods, facilitating uni-directional delivery of a pharmaceutical agent to the target site of action impacting disease progression, while limiting delivery to surrounding areas. This should enable higher efficacy, lower dosing and less toxicity to nonaffected parts. Rivelin may significantly improve the treatment paradigm for OLP and other inflammatory mucosal diseases, which today are largely addressed with unapproved or inconvenient ointments, inhalers or mouthwashes. About AFYX Therapeutics AFYX Therapeutics is a clinical-stage biopharmaceutical company focused on innovative approaches to treat mucosal diseases. AFYX’s lead product candidate, Rivelin-CLO patch, met its primary endpoint and multiple secondary endpoints in a Phase 2b clinical study for the treatment of oral lichen planus, a chronic inflammatory disease that affects over 1 percent of the population in the U.S. and Europe. The Rivelin patch technology is able to adhere to mucosal surfaces, such as the mouth, to provide continuous and targeted therapeutic delivery for diseases where topical and other treatment modalities have proven inadequate. Investors include Sofinnova Ventures, Lundbeckfonden Emerge, Novo Seeds and Welfare Tech Invest. For additional information, please visit . View source version on businesswire.com: