Redwood Pharma AB (publ) today announces that the last patient has now been included in the company’s ongoing Phase II trial of RP101 and that recruitment is thus completed. RP101 is an innovative treatment for chronic dry eyes in postmenopausal women.
Redwood Pharma’s Phase II clinical trial is a randomized, placebo-controlled multicenter study conducted in clinics in Austria, Hungary and Germany. Approximately 100 patients are evaluated during a treatment period of three months, after which the study ends with a follow-up after the last dose has been administered.
The goal is to show efficacy and safety and to determine the effective dose of RP101 for the treatment of moderate to severe disorders of dry eye in postmenopausal women. In the clinical study, sterile eye drops or matching placebo (vehicle) are administered once or twice a day. The primary endpoint is the evaluation of the clinical efficacy by the measurement of tear film production by the Schirmer test. Another parameter being studied is how well the eye drops are tolerated. Self-experienced symptoms are evaluated using a questionnaire adapted for the purpose (SANDE). Any changes in the cornea are also studied as well as several other parameters described in the study protocol.
More information about the trial can be found in the European Clinical Trials Register (www.clinicaltrialsregister.eu) under EudraCT number: 2017-005160-18 and www.clinicaltrials.gov.
Study results in the form of so-called “topline” results are expected to be published no later than the first quarter of 2020, as previously communicated.
“The company has now reached another sub-goal and is approaching the goal of commercializing a new treatment for chronic dry eyes. We are now looking forward with confidence to the study results. Positive results will take us further steps forward in our discussions with commercial partners”, says Martin Vidaeus, CEO of Redwood Pharma AB.
RP101 is the company’s lead program for the development of a novel treatment of chronic dry eye disease in postmenopausal women. The active substance is an endogenous small molecule already proven safe and effective in two Phase II clinical trials in the US. The active substance for the first time has been formulated in IntelliGel to control its release, reduce dosing and increase compliance. Redwood Pharma is starting a clinical Phase II trial of RP101 in Europe.
Dry eye disease is a large market with serious unmet needs – estimated to grow to USD 2.7 billion in 2022. RP101 will be the first therapy targeted towards a unique biological mechanism and the target patient population of postmenopausal women. With prior development data, this program will be faster to market and has lower capital needs and development risks than programs based on New Chemical Entities.
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, August 5, 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