Method of treating osteoporosis comprising administration of PTHrP analog
AssigneesRadius Health, Inc., Ipsen Pharma S.A.S.
InventorsMichael J. Dey, Nathalie Mondoly, Benedicte Rigaud, Bart Henderson, C. Richard Lyttle, Zhengxin Dong
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Abstract
The present invention provides a storage-stable composition containing a parathyroid hormone-related protein (PTHrP) and methods of using a PTHrP and the PTHrP compositions described herein to treat osteoporosis, to increase bone mass or to increase bone quality. The composition is storage stable, in sterile form, and in general may be stored at room temperature for at least several weeks to allow convenient parenteral administration to human patients.
Claims79
A method of treating osteoporosis comprising daily subcutaneous administration of a composition comprising 80 μg of [Glu22,25, Leu23,28,31, Aib29, Lys26,30]hPTHrP(1-34)NH2 to a human in need thereof.
A method of treating osteoporosis comprising daily subcutaneous administration of a composition comprising 80 μg of [Glu22,25, Leu23,28,31, Aib29, Lys26,30]hPTHrP(1-34)NH2 to a human in need thereof, wherein the composition is delivered in a multi-dose injection pen.
A method of treating osteoporosis comprising daily subcutaneous administration of a composition comprising 80 μg of [Glu22,25, Leu23,28,31, Aib29, Lys26,30]hPTHrP(1-34)NH2 to a human in need thereof, wherein the composition is prepared according to a process comprising:
- (a) dissolving [Glu22,25, Leu23,28,31, Aib29, Lys26,30]hPTHrP(1-34)NH2, an anti-microbial agent, and a buffer in water to form a solution;
- and
- (b) filtering the solution through a 0.2 micron filter.
A method of treating osteoporosis, the method comprising daily subcutaneous administration to a human in need thereof a composition comprising 80 μg of [Glu22,25, Leu23,28,31, Aib29, Lys26,30]hPTHrP(1-34)NH2, wherein the composition is formulated to achieve one or more of the following pharmacokinetic parameters:
- Pharmacokinetic
- Parameters
- Mean ± SD
- Cmax (pg/mL)
- 310 ± 54.3
- Tmax (hr)#
- 0752 (0.251, 1.01)
- Tlast (hr)#
- 7.00 (4.00.12.01
- AUC0-t (pg * hr/mL)
- 949.89 ± 493.58
- AUC0-inf (pg * hr/mL)
- 1055.6 ± 513.61
- AUC0-tau (pg * hr/mL)
- 1053.2 ± 511.27
- t1/2 (hr)
- 2.30 ± 0715
- Kel (1/hr)
- 0.335 ± 0.127
- AUCR
- 0.892 ± 0.0369
- CL/F (L/hr)
- 94.61 ± 51.09
- ln (Cmax)
- 5.722 ± 0.1732
- ln (AUC0-t)
- 6.740 ± 0.5206
- ln (AUC0-inf)
- 6.855 ± 0.5063
- ln (AUC0-tau)
- 6.853 ± 0.5050
- #= Tmax and Tlast are presented as Median (minimum, Maximum).
A method of treating osteoporosis, the method comprising daily subcutaneous administration to a human in need thereof a composition comprising 80 μg of [Glu22,25, Leu23,28,31, Aib29, Lys26,30]hPTHrP(1-34)NH2, wherein the composition is formulated to achieve one or more of the following pharmacokinetic parameters:
- Pharmacokinetic
- Parameters
- Mean ± SD
- Cmax (pg/mL)
- 436 ± 68.8
- Tmax (hr)#
- 0.507 (0.500, 1.00)
- Tlast (hr)#
- 6.00 (4.00, 8.02)
- AUC0-t (pg * hr/mL)
- 1003.0 ± 383.45
- AUC0-tau (pg * hr/mL)
- 1080.3 ± 408.57
- t1/2 (hr)
- 1.69 ± 0.425
- Kel (1/hr)
- 0.437 ± 0.124
- CL/F (L/hr)
- 82.74 ± 26.95
- AI
- 1.12 ± 0.353
- ln (Cmax)
- 6.065 ± 0.1628
- ln (AUC0-t)
- 6.851 ± 0.3623
- ln (AUC0-tau)
- 6.927 ± 0.3581
- #= Tmax and Tlast are presented as Median (minimum, Maximum).
Dependencies are inferred from the claim text.