Redwood Pharma initiates toxicological safety studies
Redwood Pharma AB (publ) now begins toxicological safety studies for its drug development project RP101. The results will initially be incorporated into the Company’s application for permission to perform the clinical Phase II trial, which represents the next stage of development for RP101. Development work continues according to plan.
The Company’s drug development project RP101, a treatment for chronic dry eye disease, will undergo two important phases during 2017. The first, which begins immediately, is regulatory toxicology testing in animal models that will demonstrate that the RP101 formulation is safe. RP101 is made up of two components: an active pharmaceutical ingredient (API) and IntelliGel®– the Company’s in-licensed system to deliver and control the release of substances in the eye. It has been earlier documented that the API is safe and effective. At the moment, the Company intends to confirm its ability, as well as safety, when combined with IntelliGel. As IntelliGel’s safety has earlier been demonstrated in human cell tests, the underlying basis and prospects for positive results for the toxicology tests are deemed good.
The second phase will be the clinical Phase II trial planned for the coming fall. RP101 will be tested in patients will chronic dry eye disease. The Company will take advantage of existing data from two earlier clinical trials in the US that demonstrated both safety and efficacy of the API.
“As we now initiate toxicology safety studies according to plan, it demonstrates the effective project management of RP101. By achieving our development goals, development risks mitigate while the commercial potential increases. We are approaching the window of opportunity where the Company can enter into commercial agreements with one or several pharmaceutical partners,” says CEO Martin Vidaeus.
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 person set out above, at March 16, 2017.
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