Immunology

MAM-1004-1/Budesolv is a nasal spray containing the corticosteroid budesonide solubilized with Marinomeds proprietary Marinosolv solubilization technology. Budesolv is intended to treat severe allergic rhinitis and has met all endpoints in a phase III clinical trial. Due to the solubilized, readily available form, a therapeutic effect could be achieved with a significantly lower dose (85% lower than comparable marketed products). Furthermore, the increased bioavailability allows a significantly faster onset of action: Budesolv led to a noticeable reduction in allergic nasal symptoms and a significant reduction in asthmatic symptoms in less than three hours after the first dose. The unique Marinosolv-formulation offers further advantages: due to the dissolved form of the active ingredient, shaking is not necessary and the risk of misdosing is greatly reduced. The formulation is free of potentially irritating preservatives and well tolerated. Furthermore, the reduction of the amount of active pharmaceutical ingredient contributes to sustainability, as less drug substance pollutes the environment, particularly the wastewater.

Allergic rhinitis (AR) is one manifestation of a type I hypersensitivity reaction caused by an immune reaction to otherwise innocuous agents such as pollen or house dust mites. The disease can occur both perennially (e.g. house dust mite allergy) or seasonally (e.g. grass pollen allergy). In the past decades, a globally rising trend of AR has been observed with widely varying prevalence, particularly in the developing countries. Up to 30% of the global population may be affected. While allergic rhinitis refers to an inflammatory process of the nasal passages, symptoms involve the nose and may extend beyond to affect the eyes, ears, sinuses and bronchi. Commonly reported nasal symptoms include nasal itching and congestion, runny nose and sneezing. Often, AR will involve the conjunctivae; such patients may experience itching, tearing and red eyes. About 40% of AR patients also suffer from asthmatic symptoms like cough, wheeze and dyspnea. In fact, AR is considered an independent risk factor for subsequent asthma. Some studies have shown that treatment for AR can reduce healthcare costs and lead to a better asthma control.

Apart from allergen avoidance and physical measures, current therapy of AR comprises two main treatment options: Pharmaceuticals targeting the effects of messenger substances secreted by mast cells or hypersensitization to specific allergens. Anti-allergic pharmaceuticals can be divided into three categories: Antihistamines prevent histamine from binding to its receptor, mast cell stabilizers (e.g. cromoglycate) are supposed to reduce the secretion of messengers, and glucocorticoids inhibit the production and release of proinflammatory substances such as TNF-alpha.

Poor solubility and associated poor bioavailability result in delayed onset of action, especially when applied locally in the nose. The suspension with undissolved particles used must be applied for a number of days before an effect occurs.

• Faster onset of action
• Reduced dose
• Preservative-free
• Suitable for sensitive tissues such as the nasal mucosa
• No shaking necessary
• Decreased risk of misdosing