Innovaderm Research, Inc.

MONTREAL--( BUSINESS WIRE )-- Allergy recently published RAPT Therapeutics’ phase 1a/1b atopic dermatitis (AD) study, in which Innovaderm Research was a key partner, serving as the contract research organization (CRO). This was a first-in-human and proof of concept randomized, placebo-controlled Phase 1a/1b monotherapy study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and CCR4 surface receptor occupancy of zelnecirnon (formerly RPT193) in eligible healthy subjects and subjects with moderate-to-severe AD. Innovaderm has distinguished itself through specific factors which were significant in the successful conduct of the clinical trial. The study design involved a single ascending dose / multiple ascending dose (SAD/MAD) portion in healthy volunteer subjects, followed by a cohort of 31 AD participants. The study featured a careful selection of the maximum dose, with a ratio of 2:1 in cohorts of subjects with moderate to severe AD, over a 4-week treatment duration. “We take pride in our contribution to this project, for it stands as a testament to our dedication, collaboration, and commitment to advancing medical research.” Robert Bissonnette M.D, FRCPC., President and Founder of Innovaderm Research Innovaderm was instrumental in the strategy and approach to site selection, with a focus on identifying sites that were not only suitable but also demonstrated genuine interest, engagement and ability to generate high quality data. This insight into pivotal factors and strategies positions Innovaderm as a leader in clinical development. The organization’s relentless dedication to advancing medical research continues to drive progress and improve patient outcomes. Innovaderm Research Inc. Innovaderm Research Inc. is a global, full-service CRO specialized in therapeutic dermatology. Founded in 2000, it partners with biotechnology and pharmaceutical companies for the collaborative management of early to late phase clinical trials. Its mission is to drive innovative research initiatives and offer new therapies for patients living with skin disease.

MONTREAL--( BUSINESS WIRE )--Innovaderm has been honored as a Champion of the 2023 CRO Leadership Awards, garnering top performer accolades across all core categories of Expertise, Capabilities, Quality, Reliability and Compatibility. By scoring as a top performer, in relation to the weighted average of other CROs included in ISR’s annual CRO Quality Benchmarking survey, Innovaderm has been awarded the additional designation of Champion. Innovaderm is the leading dermatology CRO, built upon deep dermatology expertise and over 20 years of success, offering full-service capabilities across all phases of clinical trials, towards the goal of improving patient’s lives. “CRO selection is one of the most important and strategic decision study sponsors must make for their clinical research programs. Winning organizations are selected in each of these categories based on the market research our colleagues at ISR Reports conducted with decision makers at study sponsor companies over the last 18 months. Congratulations to all the winners for your outstanding performance and vital contribution to the clinical research industry.” Amit Dua, Vice President, Market Development, Clinical Leader. “We are very pleased to have been awarded this prestigious recognition for the third year in a row, by our clients and collaborators,” Dr. Robert Bissonnette, Founder and CEO of Innovaderm, commented. “It is a tremendous honor to see our work acknowledged by biotech and pharma sponsors. At Innovaderm, we pride ourselves on the excellence in the execution and delivery of high-quality services, in the interest of advancing scientific and medical research.” To learn about Innovaderm’s services, visit our website . Innovaderm Research Inc. Innovaderm Research Inc. is the leading full-service dermatology CRO. Founded in 2000, Innovaderm’s deep expertise and experience enables the ability to operationalize all aspects of clinical research, and deliver excellence across early to late phase studies. Innovaderm’s mission is to drive innovative research initiatives towards the goal of improving patients’ lives.

MONTREAL--(BUSINESS WIRE)-- Innovaderm’s involvement in all phases of the clinical development of tapinarof culminated with a tremendous achievement: the recent approval of Dermavant Sciences Inc.’ VTAMA® (tapinarof) cream by the FDA for the treatment of plaque psoriasis in adults. Discovered in Canada, tapinarof is approved in the United States for the management of psoriasis, a chronic skin condition that causes itchy, scaly patches on different parts of the body and has a significant detrimental effect on quality of life. “This is a great milestone for patients – one that we have been working towards for years,” says Dr. Robert Bissonnette, Innovaderm’s founder and CEO. “Innovaderm is well-positioned to help companies such as Dermavant drive innovation forward by accompanying them in all stages of their clinical research from protocol writing to data analysis. We not only played an instrumental role through our participation in multicenter phase 2 and 3 studies, but we were also the first to demonstrate tapinarof’s efficacy in proof-of-concept studies in both psoriasis and atopic dermatitis.” VTAMA® cream is a once-daily, topical medication for psoriasis. Currently, clinical trials are underway to study this medication among patients with atopic dermatitis. “VTAMA® cream is a non-steroidal topical that is a new chemical entity and the first-in-class therapy to be approved in the topical psoriasis space in 25 years,” says Anna Tallman, PharmaD, Vice-President of Medical Affairs at Dermavant Sciences. “We appreciate the collaboration and partnership with Dr. Bissonnette and Innovaderm to help bring forward an effective new treatment option in the United States that has the potential to benefit adults with plaque psoriasis across the entire disease severity spectrum – from mild to severe.” Dr. Bissonnette and Tallman recently contributed to an article on the phase 3 tapinarof studies, which was published in the New England Journal of Medicine. To learn more: https://www-nejm-org.libproxy1.nus.edu.sg/doi/pdf/10.1056/NEJMoa2103629 For information on Innovaderm’s early to late phase study capabilities, visit our website. IMPORTANT SAFETY INFORMATION Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist approved in the US for the topical treatment of plaque psoriasis in adults. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in subjects treated with VTAMA cream were folliculitis (red raised bumps around the hair pores), nasopharyngitis (pain or swelling in the nose and throat), contact dermatitis (skin rash or irritation, including itching and redness, peeling, burning, or stinging), headache, pruritus (itching), and influenza (flu). You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088. See full Prescribing Information and Patient Information. Innovaderm Research Inc. Innovaderm Research Inc. is a global, full-service CRO specialized in therapeutic dermatology. Founded in 2000, it partners with biotechnology and pharmaceutical companies for the collaborative management of early to late phase clinical trials. Its mission is to drive innovative research initiatives and offer new therapies for patients living with skin disease. Dermavant Sciences Dermavant Sciences, a subsidiary of Roivant Sciences, is a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant’s focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The company’s medical dermatology pipeline includes both approved and late-stage development product candidates the company believes may address important immuno-dermatological conditions, including plaque psoriasis and atopic dermatitis. For more information, please visit www.dermavant.com, and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).