Redwood Pharma can today report that the last patient received their last dose in the company’s Phase II trial of RP101, a treatment for chronic dry eye syndrome in post-menopausal women. Thus, the treatment phase in the clinical trial is finished.
This milestone will now be followed by an intensive period in which all data from the participating clinics will be compiled and analyzed. Extensive work on data compilation and processing will continue in the coming months. In line with what has been previously communicated, management’s assessment is that topline results will be published during the first quarter of 2020.
“It is with great satisfaction that I can today report that the last patient has exited the clinical trial of RP101. All patients who completed the study underwent a 90-day treatment period to evaluate the safety and efficacy of RP101. With the help of our CRO we are now working on collecting and quality-assuring the extensive material in order to then analyze the results. We look forward to sharing results with potential licensing partners, our shareholders and the investment community as soon as the evaluation is complete, ”says CEO Martin Vidaeus.
RP101 is a novel, topical treatment for post-menopausal women suffering from chronic, moderate-to-severe dry eye disease (DED), and consists of a low-dose estrogen analog formulated in a proprietary controlled-release drug delivery platform, IntelliGel. The active substance has already been proven safe and efficacious in two Phase II clinical trials conducted in the US. Redwood Pharma is currently conducting a Phase II clinical trial of RP101 in Europe, with topline results expected during Q1 2020.
DED is the number one reason patients visit eye doctors, and this condition represents a large and growing market. Approximately 100 million suffer from chronic DED, and the global market for pharmaceuticals treating DED was valued at US$3bn in 2018. There is an urgent need for new, more effective therapies, and RP101 is positioned to be the first hormonal therapy for post-menopausal women. An estimated 7% of post-menopausal women – 10 million in the US and Europe alone – suffer from severe DED. Where conventional therapies only treat symptoms of the disease, RP101 addresses the underlying cause of the discomfort by targeting and restoring the production of critical components of the natural tear film.
For more information:
Martin Vidaeus, CEO Redwood Pharma AB (publ.)
Tel: +46 (0) 70 232 29 29
This information is information that Redwood Pharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, November 12, 2019.
About Redwood Pharma
Redwood Pharma develops ophthalmic products for unmet medical needs. The Company’s first project is the development of drug candidate RP101 with a known active substance against chronic dry eye in postmenopausal women who have moderate to severe symptoms. With the drug delivery platform IntelliGel the release of active substances is controlled. Through the use of IntelliGel, Redwood Pharma can also improve dosing of other established drugs. Redwood Pharma’s strength lies in formulation and early clinical development. Revenues will be generated through licensing agreements with pharmaceutical companies that have capabilities to manufacture and sell commercial products worldwide.
Redwood Pharma AB (publ.) is listed on Spotlight Stock Market, a Swedish Multilateral Trading Facility (Ticker: REDW.ST, ISIN: SE008294789).
For more information visit: www.redwoodpharma.com