Accelerating development of RP501 first-line therapy for dry eye disease

Regulatory

Redwood Pharma announces today a strategic move to accelerate development of RP501, the company’s IntelliGel-based topical first-line therapy for dry eye disease. While RP101 remains a clinically tested and unique candidate drug for post-menopausal women, the company will strengthen its focus on RP501 which has the potential of generating revenues in the near term for the company.

RP501 – a differentiated therapy addressing a large market

RP501 has significant therapeutic  and commercial as a next-generation first-line therapy to treat the majority of DED sufferer, including males and females of all ages. The global market is valued at US$2.3 billion in 2019 and expected to grow to US$2.9 billion by 2030 (Source: Transparency Market Research 2020). Today, these patients turn first to artificial tears (saline eye drops) to provide temporary relief.  Regular eye drops are quickly cleared from the front of the eye and need frequent reapplication, creating a need for products that stay longer on the eye and reduce the number of drops to provide daily relief.

RP501 (IntelliGel) was used as the vehicle (placebo control) in the RP101 Phase II clinical trial completed last year, and our data from the RP101 trial showed that twice daily administration of RP501 improved both symptoms and objective measures of DED, even in patients with severe disease. In this trial, RP501 demonstrated increased tear fluid production as measured by the Schirmer test. Likewise, it improved various symptoms including foreign body sensation and dryness. RP501, as an easy-to-apply alternative to artificial tears providing long-lasting relief with fewer instillations per day, may thus offer a convenient and differentiated solution to over 340 million people worldwide suffering from DED.

Next steps

The Redwood Pharma team has been working along with clinical and regulatory consultants to understand the regulatory pathways and identify and initiate activities to fill information gaps for regulatory approvals in Europe and the United States. The company has already successfully completed a laboratory test demonstrating compatibility of RP501 (IntelliGel) with commercial contact lenses with positive results. Based upon these results, Redwood has now decided to accelerate the pace of development towards a commercial medical device. Key next steps in the development of RP501 include:

• Determine optimal regulatory strategy in Europe and the United States
• Perform necessary supplementary in vitro testing for medical device regulatory approvals
• Initiate and complete a clinical trial for supplementary testing in DED sufferers including those wearing contact lenses

Barring unforeseen issues by Notified Bodies, the company’s funds are estimated to cover in vitro and clinical testing, as well as obtaining a CE-mark in EU. More work is now being done to understand the US regulatory approach and budget for US market clearance. Redwood’s Board of Directors and management team are focused on the development of RP501 as a program with near-term revenue potential. RP501 represents an extension of the RP101 program, building on the results of the company’s RP101 Phase II trial, the knowledge then acquired and the investment already made by our shareholders.

RP101 – a drug candidate ready for final phase of clinical development

In March 2020, Redwood Pharma released topline results of the Phase II clinical trial of RP101, the company’s treatment for moderate-to-severe DED in post-menopausal women. Since then, the company has been intensively analyzing the trial results and the efficacy of RP101, and planning for future clinical development. While RP101 did not meet its primary Schirmer’s test endpoint, it did demonstrate safety and efficacy on several crucial objective and subjective measures versus both baseline and vehicle. These data give support to RP101 as a treatment for moderate-to-severe DED in post-menopausal women, and have guided the design of pivotal trials necessary for product marketing approvals.

Since topline readout, Redwood Pharma has discussed various development and licensing arrangements regarding RP101 with a number of large pharma and more specialized pharmaceutical companies. Feedback from clinical perspectives and commercial proposals has been varied in nature. That said, Redwood has not yet found a mutually satisfactory collaborative or financial solution with a partner to move the program forward at this time.  Redwood believes that RP101 can become a significant commercial therapy to help the large segment with a large medical need of post-menopausal women suffering from chronic DED. However, management believes that the short-term focus of company resources should be on accelerating development of RP501, which has a much lower capital requirement, so as to more quickly bring a program to market. In this manner, Redwood Pharma can best build value for the company and its shareholders.

CEO Martin Vidaeus states: “RP101 is a Phase III-ready program having shown significant clinical potential in a Phase II trial. Management and key opinion leaders agree that the clinical data are significant and can serve as a foundation for the next clinical phase. Until we have a clear partnering solution for RP101, our focus will, however, be on accelerated development of RP501. We are very positive about the product’s unique potential among first-line treatments for dry eye.”

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 October 25, 2021 at 8:50 a.m. CET.

For further information

Martin Vidaeus – CEO, Phone: +46 70-232 29 29

Email: 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 is currently developing treatments for dry eye disease in various target patient populations. The RP101 program targets moderate-to-severe dry eye disease in post-menopausal 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 of all ages. 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 stock market (Ticker: REDW.ST, ISIN: SE008294789).

For more information visit: www.redwoodpharma.com

2021-10-25