Redwood Pharma has now also received approval from the German Federal Institute for Drugs and Medical Devices (BfArM) to initiate the clinical trial of RP101, the company’s new drug candidate for treatment of chronic dry eyes in postmenopausal women. This means that Redwood Pharma has obtained all planned national approvals in Austria, Hungary and Germany.
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. Patients will be evaluated over 12 weeks and where the primary endpoint for efficacy will be the proportion of patients that demonstrate an improved tear production.
“The German approval means that Redwood Pharma can now plan and start clinical activities in all countries involved in the study. We are now working with our CRO, local partners and clinics to ensure an efficient recruitment of patients for the trial,” says CEO Martin Vidaeus.
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, January 7, 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