The Alitair Pharmaceutical strategy is to acquire late-stage orphan drug products already approved for therapeutic use outside the United States. This in–licensing-based approach is extremely efficient. In our experience, a typical European-approved product can move rapidly to a late-stage Phase II trial and sometimes a Phase III trial in the United States. To this end, we recently in-licensed ALT-07 and ALT-09, two drugs that are widely used to treat various respiratory diseases; we intend to develop these products for several orphan respiratory indications in the United States. As Orphan Drugs, each product will hold a 7-year exclusivity period, at a minimum.
ALT-09 is a mucolytic drug approved for the treatment of chronic bronchitis and chronic obstructive pulmonary disease (COPD) in more than 30 countries. ALT-09 is also an oral agent, so it will likely deliver the benefit of improved compliance versus ICS. Three small clinical trials of ALT-09 for the treatment of bronchiectasis in conjunction with chest physiotherapy have been completed. All three studies showed a benefit from adding ALT-09 to the treatment regimen. The studies showed a significant treatment effect on forced expiratory volume in one second (FEV1) and forced expiratory vital capacity (FEVC). We received an orphan drug designation for ALT-09 for the treatment of bronchiectasis in the United States. ALT-09 is the lead Orphan Drug product in the Alitair portfolio and will be entering Phase II studies shortly.
ALT-07 possesses many characteristics that make it an exciting alternative to current therapies in the orphan respiratory disease space. ALT-07 is administered orally, so it has much higher levels of compliance and adherence when compared to the current, predominantly inhaled treatments. Fundamentally, ALT-07 is safer and better tolerated than inhaled long-acting beta agonists (LABAs) and inhaled cortico-steroids (ICS), which are currently the mainstay of orphan respiratory disease treatment. Recent studies regarding the use of long-acting beta agonists have suggested that in rare cases severe asthma attacks and deaths may be associated with their use, resulting in a black box warning for LABA medications. Additionally, there is evidence that inhaled steroids may be associated with growth retardation in children and osteoporosis in adults. ALT-07 delivers both bronchodilation and anti-inflammatory effects in one oral drug without these side effects. We were granted orphan drug designation for ALT-07 for the treatment of bronchiectasis in the United States.