Redwood Pharma has submitted an application for the start of clinical trial
Redwood Pharma has submitted its first national clinical trial application for the start of the RP101 trial. This application represents a significant milestone in the development of the Company’s novel treatment for chronic dry eye disease (DED) in postmenopausal women.
“It is with satisfaction that we can announce that our first clinical trial application has been submitted to a national authority and ethical committee. The start of the clinical trial is planned for Q3 assuming required approvals have been granted. After completion of the toxicology studies at the end of 2017 and a scientific advisory meeting with the Swedish Medical Products Agency, we are entering the clinical trial phase to study efficacy and safety of our new drug candidate for the treatment of DED. As another milestone has been achieved, we approach the future with continued confidence”, 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 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, July 9, 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 AktieTorget, a Swedish Multilateral Trading Facility (Ticker: REDW.ST, ISIN: SE008294789).
For more information visit: www.redwoodpharma.com