Redwood Pharma AB (publ) today announces that the first patient has begun testing ofRP101 in a Phase II clinical trial. RP101 is an innovative treatment for chronic dry eye disease in postmenopausal women.
Redwood Pharma’s Phase II clinical trial is a randomized and vehicle (placebo) -controlled multicenter study that will be conducted at clinics in Austria, Hungary and Germany. Approximately 100 patients will be each evaluated during a 3-month treatment period.Assuming the trial proceeds according to plan, results of the trial should be published no later than Q1 2020.
The objectives are to show efficacy and safety and to establish the effective dose/dose regimen of RP101 in post-menopausal women with moderate to severe dry eye syndrome applying RP101 ophthalmic sterile solution or matching placebo (vehicle) 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. Secondary endpoints include measuring ocular tolerability and the patient’s own symptoms using the SANDE survey. Corneal fluorescein staining will be performed among many different measures pursuant to the study protocol.
“We are very pleased that the first patient has started the treatment in our Redwood Pharma-sponsored study with RP101. The study will recruit patients with an urgent need to reduce the symptoms of moderate to severe dry eye syndrome where there are inadequate therapies today”, commented Martin Vidaeus, CEO of Redwood Pharma AB.
More information about this study can be found in the European Clinical Trials Register (www.clinicaltrialsregister.eu) under the EudraCT Number: 2017-005160-18.
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, February 4, 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 (formerly AktieTorget), a Swedish Multilateral Trading Facility (Ticker: REDW.ST, ISIN: SE008294789).
For more information visit: www.redwoodpharma.com