Redwood Pharma receives approval from the Austrian drug authority to start RP501 clinical trial
Redwood Pharma has received approval from the Austrian Federal Office for Safety in Health Care (BASG) to initiate the clinical trial of RP501, the company’s new drug candidate for first-line treatment of dry eye disease. Following the approval from the Austrian Ethics Commission earlier this month, this is the second and final approval required for the company to begin clinical work.
To support future product claims, Redwood Pharma is conducting a single-center trial led by Prof. Gerhard Garhöfer who states, “We are excited to start this trial at the Medical University of Vienna, Austria. Dry eye is a disease with many sufferers and where new treatments are needed. As a unique thermogel, RP501 has the potential of providing relief to many. ”
60 patients will be divided into groups to assess the safety and efficacy in patients with and without contact lenses. Treatment duration will vary between patient groups where one group will be treated over a month and another over three months. Results of the trial will be used to support a CE-mark, as well as other regulatory market clearances. Furthermore, the results will serve as an important platform in the next commercial phase. With this approval, Redwood Pharma can begin including patients shortly.
“We are very happy to receive this approval from the Austrian authority with the help of our partnering CRO and Prof. Garhöfer. This trial represents the next step in the development and commercialization of RP501, which we strongly believe can help provide therapeutic relief to dry eye sufferers. As we have already seen the significant effects of RP501 in the company’s Phase II trial, we anticipate strong commercial potential of this new product,” says CEO Martin Vidaeus.
This disclosure contains information that Redwood Pharma is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 28-03-2022 15:15 CET.
For more information:
Martin Vidaeus, CEO Redwood Pharma AB (publ.)
Tel: +46 (0) 70 232 29 29
E-mail: martin.vidaeus@redwoodpharma.com
About Redwood Pharma
Redwood Pharma develops ophthalmic products for unmet medical needs through novel approaches. In providing commercial partners and their customers with effective medical solutions, the company currently has products in development to treat dry eye disease in different target patient populations. The RP101 program targets moderate-to-severe dry eye disease in postmenopausal women by delivering a low-dose estrogen therapy to the front of the eye. The RP501 program aims to treat milder forms of dry eye in a broader patient population including both men and women. For other potential drug substances and therapeutic areas, the Company can employ the IntelliGel drug delivery platform that enhances patient convenience by controlling dosing and potentially reducing the number of instillations per day and subsequent side-effects. Redwood Pharma leverages its strengths in early clinical development and aims to generate revenues through, among others, licensing agreements with companies that have capabilities to manufacture and sell medical products worldwide.
Redwood Pharma AB (publ) is listed on the Nasdaq First North Growth Market (Ticker: REDW.ST, ISIN: SE008294789).
For more information visit www.redwoodpharma.com