Savara has filed a patent for a liquid formulation of recombinant human granulocyte macrophage colony stimulating factor (rhGM-CSF) for inhalation by nebulization. The formulation includes rhGM-CSF, a sugar alcohol or sugar, albumin, and water. GlobalData’s report on Savara gives a 360-degree view of the company including its patenting strategy. Buy the report here.
According to GlobalData’s company profile on Savara, nebulizers and atomisers was a key innovation area identified from patents. Savara's grant share as of June 2023 was 1%. Grant share is based on the ratio of number of grants to total number of patents.
Inhalable liquid formulation of recombinant human gm-csf
A recently filed patent (Publication Number: US20230201307A1) describes a liquid formulation of recombinant human granulocyte macrophage colony stimulating factor (rhGM-CSF) for inhalation administration. The formulation includes rhGM-CSF, a sugar alcohol or sugar, albumin, and water. The patent claims specify various concentrations and components of the formulation.
The liquid formulation can include different types of rhGM-CSF, such as molgramostim, sargramostim, or regramostim. The sugar component can be maltose, trehalose, sucrose, mannose, lactose, or galactose, while the sugar alcohol can be mannitol or sorbitol. The albumin used in the formulation is recombinant human albumin. Additionally, the formulation may contain polyethylene glycol (PEG), with specific options listed, such as PEG 1000, PEG 1550, PEG 2000, PEG 3000, PEG 3350, PEG 4000, or PEG 8000, preferably PEG-4000.
The concentration of rhGM-CSF in the formulation is at least 150 µg/mL, with a preferred range of 150-500 µg/mL, specifically 200-300 µg/mL. The concentration of the sugar alcohol is at least 25 mg/mL, with a preferred range of 45-100 mg/mL, specifically 45-55 mg/mL. The concentration of albumin is at least 0.2 mg/mL, with a preferred range of 0.5-1.5 mg/mL. The concentration of PEG is specified as a maximum value, with options ranging from 50 mg/mL to 1 mg/mL, and a preferred range of 0.05-0.15 mg/mL.
The liquid formulation can also include a buffer, such as citric acid monohydrate or Na2HPO4. The osmolality of the formulation should be within the range of 250 to 375 mOsm/L, preferably from 325 to 335 mOsm/L. The patent claims also highlight the stability of the formulation, with at least 60% of rhGM-CSF remaining after 3 months of storage at 40°C and less than 5% impurity formation after 6 months at 25°C. The formulation should retain at least 90% biologic potency of rhGM-CSF after nebulization and remain storage stable for at least 18 months at 25°C.
The liquid formulation is intended for inhalation administration, specifically for use in pulmonary administration. It can be used for the treatment of lung infections, including bacterial, viral, or fungal infections. Additionally, it may be used for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP) or non-tuberculous mycobacterial (NTM) infection. The patent also mentions an inhaler, specifically a nebulizer, that contains the liquid formulation for easy administration. Finally, a method for delivering rhGM-CSF to the lungs is described, involving the nebulization of the liquid formulation.