(Stockholm, Sweden, May 5, 2022) Redwood Pharma AB (publ) today announces that the first patient has been included in the company’s clinical trial of RP501 and has also started treatment. The RP501 medical device with its innovative thermogelling properties is expected to constitute an effective and unique addition to first-line treatment for patients suffering from dry eye disease.
Redwood Pharma’s clinical trial is a single-center study that will be conducted at the Medical University of Vienna, Austria, under the guidance of Principal Investigator Prof. Gerhard Garhöfer. 60 patients will be divided into groups of patients with and without contact lenses. Contact lens wearers will be treated over a month, while non-wearers will be treated over 3 months. Trial results are expected no later than Q1 2023.
RP501 (IntelliGel) is currently being developed as a medical device in Europe. The safety and efficacy of RP501 was tested in the RP101 Phase II trial conducted by Redwood Pharma in post-menopausal women. In that trial RP501 (the vehicle control) improved both subjective symptoms and objective signs such as dryness, foreign body sensation, tear fluid production, tear break-up time and corneal staining.
In accordance with the new European Medical Device Regulation (MDR, EU regulation 2017/745), the objectives of the trial are to show safety and efficacy of RP501. Treatment efficacy in individual patients will be evaluated using various objective and subjective measures. The results of the trial will be used in the filing of a CE-mark application.
“We are very pleased that the first patient has started the treatment in our Redwood Pharma-sponsored study with RP501. The study will recruit patients with a need to reduce symptoms of dry eye. With positive results, Redwood Pharma believes that RP501 can become a significant commercial therapy”, stated Martin Vidaeus, CEO of Redwood Pharma AB.
RP501 will address a large market where there is a need for better therapies that offer effective relief from dry eye with fewer administrations per day. RP501 has significant therapeutic and commercial potential as a next-generation first-line therapy to treat the majority of dry eye sufferers, including males and females of all ages. The global market was valued at US$2.3 billion in 2019 and expected to grow to US$2.9 billion by 2030 (Source: Transparency Market Research 2020). Today, dry eye disease sufferers turn first to artificial tears (saline eye drops) to provide temporary relief.
This disclosure contains information that Redwood Pharma is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on May 5, 2022 14:00.
For further information
Martin Vidaeus – CEO, Phone: +46 70-232 29 29
About Redwood Pharma
Redwood Pharma develops ophthalmic products for unmet medical needs through novel approaches. In providing commercial partners and their customers with effective medical solutions, the Company is currently developing treatments for dry eye disease in various target patient populations. The RP101 program targets moderate-to-severe dry eye disease in post-menopausal women by delivering a low-dose estrogen therapy to the front of the eye. The RP501 program aims to treat milder forms of dry eye in a broader patient population including both men and women of all ages. For other potential drug substances and therapeutic areas, the Company can employ the IntelliGel drug delivery platform that enhances patient convenience by controlling dosing and potentially reducing the number of instillations per day and subsequent side-effects. Redwood Pharma leverages its strengths in early clinical development and aims to generate revenues through, among others, licensing agreements with companies that have capabilities to manufacture and sell medical products worldwide.
Redwood Pharma AB (publ) is listed on the Nasdaq First North Growth stock market (Ticker: REDW.ST, ISIN: SE008294789).
For more information visit: www.redwoodpharma.com