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Marinomed Biotech AG Reports Encouraging Topline Data for Phase II Clinical Trial of Tacrosolv in Allergic Rhinoconjunctivitis

·6-min read

DGAP-News: Marinomed Biotech AG / Key word(s): Study results
01.07.2021 / 07:45
The issuer is solely responsible for the content of this announcement.

Marinomed Biotech AG Reports Encouraging Topline Data for Phase II Clinical Trial of Tacrosolv in Allergic Rhinoconjunctivitis

Korneuburg, Austria, 01 July 2021 - Marinomed Biotech AG (VSE:MARI), an Austrian science-based biotech company with globally marketed therapeutics derived from innovative proprietary technology platforms, announced today the topline results for its Phase II clinical trial of Tacrosolv eye drops to treat ocular hay fever symptoms. The placebo-controlled Phase II clinical trial was conducted at the Vienna Challenge Chamber (Austria) to assess safety and efficacy of two different dose of Tacrosolv in a crossover design. The applied doses contained only 2.5 % and 5 % of the dose used in Tacrolimus eye drops that are marketed in Japan for the treatment of vernal conjunctivitis. After one week of treatment, the higher dose resulted in a statistically significant reduction of ocular symptoms in the time period starting 3.5 hours after the challenge (p < 0.05). A comparison of the ocular symptoms on day 1 with day 8 showed a significant reduction of symptoms in the case of Tacrosolv treatment (p < 0.01) without any effect of the placebo treatment. Additionally, nasal symptoms were assessed and showed a significant reduction at day 8 (between 0 to 4 hours after the challenge, p < 0.05). These results indicate the high potential of tacrolimus being an effective treatment of ocular inflammation exemplified by allergic conjunctivitis and other allergic manifestations.

"The higher dose showed significant relief of allergic symptoms in the eyes and also in the nose. The latter is surprising and supports the effectiveness of Tacrolimus also in allergic rhinitis. This topline data strongly supports our hypothesis that a fully solubilized Tacrolimus can be developed as an effective therapy for ocular inflammation including dry eye disease and rhinoconjunctivitis," commented Dr. Eva Prieschl-Grassauer, Chief Scientific Officer of Marinomed.

The study was conducted as a randomized, placebo-controlled, crossover, double-blind, single site Phase II clinical trial. Patients received Tacrosolv eye drops (50 µg / ml eye drop) in either a high (two drops per day) or low dose (one drop per day) compared to placebo (3 % propylene glycol in saline) in two treatment cycles. In the first treatment cycle, patients were administered Tacrosolv or placebo for 8 days. This was followed by a washout period of at least 13 days. In the second treatment cycle, treatment was switched to placebo or Tacrosolv eye drops, respectively.

Tacrolimus is a macrolide immunosuppressant used for various inflammatory conditions. Currently, the only available tacrolimus-containing eye drop product is formulated as a suspension at 1 mg / ml and marketed in Japan. Tacrosolv is a novel aqueous formulation of solubilized tacrolimus based on the Marinosolv platform developed by Marinomed. By complete solubilization of the active ingredient, the new formulation allows the use of low concentrated tacrolimus resulting in a scientifically proven enhanced bioavailability to reduce ocular inflammation.

About Marinosolv(R):
Marinosolv(R) is an innovative technology platform that enables solubilization of many barely soluble compounds and in consequence, opens new possibilities in treating a multitude of diseases. While organic compounds could previously often only be delivered as a suspension, Marinosolv(R) provides aqueous formulations without preservatives with a faster onset of action and increased local bioavailability. In addition, they can be used without prior shaking, thus improving usability and enabling reliable dosing in sensitive tissues such as eyes or nose. Overall, the use of the Marinosolv(R) technology can facilitate efficient drug delivery with high local availability and low systemic off-target activity. Even off-patent active ingredients can be patented as part of new formulations developed using Marinosolv(R), while keeping production processes cost-efficient. For more information on Marinosolv(R), please visit https://www.marinosolv.com/en, and for a list of scientific publications on Marinosolv(R), https://www.marinosolv.com/en/publications.

About Marinomed Biotech AG
Marinomed Biotech AG (Korneuburg, Austria) (VSE:MARI) is an Austrian science-based biotech company with globally marketed therapeutics listed on the Prime Market of the Vienna Stock Exchange. The company focuses on the development of innovative products based on two patent-protected technology platforms. The Marinosolv(R) technology platform increases the efficacy of hardly soluble compounds for the treatment of sensitive tissues such as eyes, nose, lung or gastrointestinal tract. The Carragelose(R) platform comprises innovative patent-protected products targeting viral infections of the respiratory tract and can reduce the risk of an infection with SARS-CoV-2. Carragelose(R) is used in nasal sprays, throat sprays and lozenges, which are sold via international partners in over 40 countries worldwide. Marinomed, Marinosolv(R) and Carragelose(R) are registered trademarks of Marinomed AG. These trademarks may be owned or licensed in select locations only. Further information is available at https://www.marinomed.com/en/technologies-markets/markets.

For further inquiries contact:

Marinomed Biotech AG
Lucia Mayr-Harting
Public Relations
Hovengasse 25, 2100 Korneuburg, Austria
T +43 2262 90300
E-mail: pr@marinomed.com
http://www.marinomed.com

International Media and IR Contact
MC Services AG
Dr. Brigitte Keller, Julia Hofmann
T +49 89 210228 0
UK: Shaun Brown
M: +44 7867 515 918
E-mail: marinomed@mc-services.eu

 

Disclaimer
This press release contains forward-looking statements, which are based on current views, expectations and projections of the management of Marinomed Biotech AG about future events. These forward-looking statements are subject to risks, uncertainties and assumptions that could cause actual results, performance or events to differ materially from those described in, or expressed or implied by, such statements. The current views, expectations and projections of the management of Marinomed Biotech AG may be identified by the context of such statements or words such as "anticipate," "believe", "estimate", "expect", "intend", "plan", "project" and "target". Forward-looking statements are only valid as of the date they are made and Marinomed Biotech AG does not assume any obligation to update, review or revise any forward-looking statements contained in this press release whether as a result of new information, future developments or otherwise.


01.07.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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