Last Patient Completes Marinomed Biotech AG's Phase II Clinical Trial of Tacrosolv to Treat Ocular Hay Fever Symptoms

• Treatment period of Tacrosolv phase II trial concluded
• Results for investigational eye drops against allergic rhinoconjunctivitis (hay fever) expected by mid-2021
• Tacrosolv, a Marinosolv-based formulation of tacrolimus, promises higher bioavailability for local treatment of ocular inflammation

Korneuburg, Austria, 12 April 2021 - Marinomed Biotech AG (VSE:MARI), an Austrian science-based biotech company with globally marketed therapeutics derived from innovative proprietary technology platforms, announced today that out of the initially enrolled 64 patients, all 62 patients included in the treatment cycles have now concluded the Phase II clinical trial^[1] evaluating Tacrosolv eye drops in allergic rhinoconjunctivitis, i. e. hay fever affecting both the eyes and nose. The randomized, placebo controlled, double-blind phase II clinical trial was conducted at the Vienna Challenge Chamber (Austria) to assess safety and efficacy of two different dosages of Tacrosolv in a crossover design. Positive results provided, the Company plans to extend the ophthalmic use of Tacrosolv to further indications beyond allergic symptoms such as dry eye disease (keratoconjunctivitis sicca) and other types of ocular inflammation.

"We are very pleased to conclude the active part of our phase II Tacrosolv. We are confident that the results will support our hypothesis that Tacrosolv is the first formulation of this highly potent immunosuppressant that allows for its use as an effective therapy in ocular inflammation," said Dr. Eva Prieschl-Grassauer, Chief Scientific Officer of Marinomed. "Formulated with Marinosolv, we could achieve a more than 200-fold higher solubility compared to water enabling the use of tacrolimus in eye drops. Moreover, our formulation has a high local bioavailability - characteristics we have seen for several Marinosolv formulations so far."

Tacrosolv is an improved formulation of tacrolimus, an immunomodulator that can suppress inflammatory reactions, including allergic symptoms. The now off-patent blockbuster drug is poorly soluble, so far limiting its usefulness for ophthalmic applications.

Allergic rhinitis and allergic rhinoconjunctivitis (hay fever) are extremely common conditions, affecting up to 25 % of people in Europe.^[2] While not life-threatening, hay fever severely impacts patients' quality of life.^[3],[4] According to experts, socioeconomic costs of up to €84 billion per year could be saved with adequate treatment of allergies in the European Union.^[5]

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.

References
^[1] Further information: https://www.marinomed.com/en/news/marinomed-biotech-ag-enrolls-first-patient-in-clinical-study-of-inhaled-carragelose-to-treat-covid-19-infections
^[2] https://www.ecarf.org/en/information-portal/allergic-diseases/allergic-rhinitis/
^[3] Blaiss MS, Ann Allergy Asthma Immunol. 1999; 83(5):449-54. https://doi.org/10.1016/S1081-1206(10)62850-5
^[4] Thompson AK et al., Ann Allergy Asthma Immunol. 2000; 85(5):338-47. https://doi.org/10.1016/S1081-1206(10)62543-4
^[5] Zuberbier T et al., Allergy 2014;69(10):1275-9. https://doi.org/10.1111/all.12470

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