Kurs & Likviditet
Beskrivning
| Land | Sverige |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Bioteknik |
(Stockholm, Sweden, Sep. 8, 2020) Redwood Pharma is announcing today the launch of a new program to develop treatments based on IntelliGel to help patients suffering from mild dry eye.
IntelliGel is the carrier used in the company's RP101 estrogen therapy targeted at moderate-to-severe dry eye disease in post-menopausal women, which recently completed Phase II testing. In those Phase II trials (which were successful for RP101), the company's scientists made the unexpected discovery that IntelliGel alone showed significant activity in safely relieving both signs and symptoms of dry eye disease. This observation has inspired the company to seek to develop IntelliGel as a treatment for mild dry eye disease targeting both men and women of all ages needing temporary relief. This new program will expand the company's portfolio, offering therapeutic relief to a much broader market.
Dry eye is a large indication, with multiple etiologies and degrees of severity, and a number of unmet medical needs. Numerous therapeutic approaches are in use, and no single medication or procedure is universally effective. With the clinical Phase II success of the RP101 program, which will address the needs of a large market segment of post-menopausal women suffering from chronic, moderate-to-severe dry eye, this new IntelliGel-based therapy will offer temporary relief to both male and female mild sufferers of all ages.
To capitalize on this discovery and assess the commercial potential of IntelliGel as a dry eye therapy, the company consulted Key Opinion Leaders (KOLs) and conducted a market survey of mild sufferers in the US and Europe. This work confirmed the need for new therapies that can address mild or transient symptoms, especially if they can last longer and reduce the number of administrations needed. The non-clinical survey confirms that patients are dissatisfied with current therapies and more than 70% of those surveyed found the IntelliGel product, as described, attractive. An estimated 40% of those surveyed would be interested in switching to it from their current products used today.
"Dry Eye Disease is a highly prevalent ocular condition, with various causes, that is a significant burden to affected patients" says Professor Gerhard Garhöfer from the Medical University of Vienna Austria. "In its Phase II trial, RP101 showed significant improvements in the treatment for moderate-to-severe dry eye disease in post-menopausal women, and in addition, preliminary data on the performance of IntelliGel in the RP101 Phase II trial suggest ideal properties of IntelliGel for the treatment of milder forms of Dry Eye Disease: strong effects on Dry-Eye-related symptoms with only twice-daily administration. These results, together with an excellent safety profile, make a strong case for the further development of IntelliGel as a promising new agent to treat Dry Eye related symptoms in mild sufferers."
With over 15 million diagnosed patients with mild dry eye in both the US and Europe, the commercial opportunity is very substantial. The global market for therapies offering temporary dry eye relief was valued at around USD 2 billion in 2016 and is growing rapidly, according to Transparency Market Research (2017). It is estimated that the total market for all dry eye products will grow from USD 5 billion today to USD 7 billion in 2025.
CEO Martin Vidaeus states, "We were surprised and excited to discover that IntelliGel works not only as a highly effective drug delivery platform, but also as a therapeutic in its own right. A welcome bonus from the RP101 Phase II trial was the demonstration that IntelliGel alone has clinical effects on signs of disease such as the production of tear fluid that other leading products on the market do not have - this will clearly differentiate our product and attract attention from clinicians and patients. Based on our investigations together with external consultants, we have determined that IntelliGel can be expected to be classified as a medical device in Europe, allowing a considerably faster and less costly development pathway than a typical pharmaceutical product. We are exploring how IntelliGel would be considered in other geographical markets. Following the important observations on IntelliGel's properties in the RP101 Phase II trial, Redwood has taken steps to secure its intellectual property foundation by filing a patent application regarding the use of IntelliGel in dry eye therapy. With the help of experts, the company will now complete our development plan and regulatory strategy. RP101 and IntelliGel will address different market segments, providing patients with more solutions to their medical needs."
About IntelliGel
IntelliGel is Redwood Pharma's exclusive technology for delivering drug to the front of the eye with a new hydrogel based on poloxamers and water. IntelliGel is applied as eye drop and gels on contact with the eye. This transparent, lubricating, reversible thermogel can increase the bioavailability of the active substance. The IntelliGel delivery platform can be used for prescription products as well as for OTC products. In addition a new development program will now be initiated to investigate the possibilities of IntelliGel as a standalone therapy for mild dry eye. IntelliGel is currently used in dermatological products sold commercially in the US and China.
About RP101
RP101 is a novel, topical treatment for post-menopausal women suffering from chronic, moderate-to-severe dry eye disease (DED). This Phase II product candidate consists of a low-dose estrogen analog formulated in IntelliGel, a proprietary controlled-release drug delivery platform, and will be the first hormonal therapy for DED targeted to specific underlying biological mechanisms in critical tissues in and around the eye. Redwood Pharma recently completed and published successful results of a randomized, placebo-controlled multicenter Phase II trial in March of 2020.