VIENNA—A pivotal Phase 3 study for Budesolv has provided Marinomed Biotech AG, a global biopharmaceutical company headquartered in Vienna, with clinical validation of the efficacy of its innovative Marinosolv technology platform. The available data proves that after one week of treatment, Budesolv 10µg achieves at least the same effect with a dose six times lower than Rhinocort Aqua 64µg, the current marketed reference product.
Budesolv is a new formulation of the compound budesonide based on Marinomed’s Marinosolv platform. Whereas currently marketed steroid nasal sprays for allergic rhinitis contain the active compounds as largely undissolved suspensions, Marinosolv enables the substance to be fully dissolved.
A study with subjects suffering from allergic rhinitis showed that after one week of treatment, Budesolv had an equivalent effect compared to that of the marketed product despite the lower dose. This data shows that the complete dissolution and the resulting improved bioavailability of a substance offers significant, clinically relevant benefits.
The results of the study also show that the symptoms of allergic rhinitis improve even after the first dose of Budesolv. This effect was not observed with Rhinocort Aqua. The planned primary and secondary endpoints of the study have been achieved, facilitating the planned entry into the multi-billion dollar market for therapies to treat allergic rhinitis. Marinomed is adhering to its timelines for approval of Budesolv and subsequent European market launch in 2021.
Principal investigator and allergologist Dr. Petra Zieglmayer was pleasantly surprised by the results, particularly about those from the hours following the first dose. “While it is already a major success that a product with a greatly reduced dose of the active compound compared to the marketed product achieves an equivalent effect after one week of treatment, the data following the initial dose are quite astounding. Experience with Rhinocort Aqua suggests no effect of the treatment within the first few hours after the initial dose compared to placebo. In contrast, Budesolv showed a pronounced reduction of allergic nasal symptoms within four hours compared to the symptoms before the initial dose and to placebo.”
“This efficacy is also apparent for allergic symptoms associated with asthma,” Zieglmayer continued. “In the asthma score, a strong reduction compared to placebo immediately after the initial dose of Budesolv was confirmed. No such effect was observed with the reference product Rhinocort Aqua. Patients can therefore expect a noticeable and durable improvement in symptoms already within the first few hours after initial application of Budesolv. Budesolv thus represents the first real innovation in the treatment of allergies with budesonide in many years.”
Marinomed is also currently developing a therapy to treat allergic conjunctivitis, using the product Tacrosolv. Through its two flagship products, Budesolv and Tacrosolv, the company plans to enter the multi-billion-dollar market for the treatment of allergies and ophthalmic conditions. Marinosolv products will be marketed through partners once approval is granted.
“We are delighted about the successful outcome of the first study involving a product based on the Marinosolv technology. Our general assumptions that solutions are superior to suspensions have been confirmed. This also means that we can be optimistic about continuing our follow-on projects based on the Marinosolv technology,” added Dr. Eva Prieschl-Grassauer, chief scientific officer of Marinomed.