Redwood Pharma has received its first national approval from the Hungarian National Ministry of Pharmacy regarding the start of the RP101 clinical trial. The approval represents the go-ahead for the first clinical Phase II trial for the new drug candidate for chronic dry eye disease in postmenopausal women.
“The approval means that Redwood Pharma can start to include patients in the clinical trial. That the Hungarian National Ministry of Pharmacy has approved the study is a big step forward for our team and partners, which have made this possible. It is with great satisfaction that another milestone on the way to the start of the trial has been achieved”, says CEO Martin Vidaeus.
Redwood Pharma intends to conduct the trial in two other countries in Europe. Applications in those countries are underway.
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 plans to conduct 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, November 12, 2018.
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