DGAP-News

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

DGAP-News: Marinomed Biotech AG / Key word(s): Study Last Patient Completes Marinomed Biotech AG's Phase II Clinical Trial of Tacrosolv to Treat Ocular Hay Fever Symptoms 12.04.2021 / 07:45 The issuer is solely responsible for the content of this announcement. 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."