BYM338 in Chronic Obstructive Pulmonary Disease (COPD) Patients With Cachexia
BYM338 in Chronic Obstructive Pulmonary Disease (COPD) Patients With Cachexia
This study will assess the pharmacodynamics, pharmacokinetics, safety and tolerability of
 BYM338 in patients with COPD and cachexia. The primary outcome will be a change in thigh
 muscle volume compared to placebo. The study will last for approximately 24 weeks.
Inclusion criteria:

 -  Written informed consent must be obtained before any assessment is performed.

 -  Males and females ages 40 to 80 years

 -  Smoking history of at least 10 pack-years

 -  Diagnosis of COPD according to GOLD guidelines (GOLD, 2010), with a
 post-bronchodilator FEV¬1 < 80% predicted and FEV1/FVC ratio < 0.70

 -  BMI <20 kg/m2 or skeletal muscle mass index by DXA < 7.25 kg/m2 for men or <5.45 kg/m2
 for women.

 -  In general stable health, including managed COPD, by past medical history, physical
 examination, vital signs at baseline as determined by the investigator.

 Exclusion criteria:

 -  Patients with MRC dyspnoea grade 5 (i.e. patients too breathless to leave the house or
 breathless when dressing)

 -  Plans for lung transplantation or lung reduction surgery within four months of
 enrollment

 -  Patients participating in a formal pulmonary rehabilitation program within 3 months of
 dosing

 -  History of malignancy of any organ system (other than excised non-melanomatous
 carcinoma of the skin), treated or untreated, within the past 5 years, regardless of
 whether there is evidence of local recurrence or metastases.

 -  Diseases other than cancer known to cause cachexia or muscle atrophy, including but
 not limited to congestive heart failure of any stage, chronic kidney disease
 (estimated GFR < 30 mL/min using the MDRD equation), rheumatoid arthritis, primary
 myopathy, stroke, HIV infection, tuberculosis or other chronic infection, uncontrolled
 diabetes mellitus, etc.

 -  Inflammatory bowel disease, celiac disease, short bowel syndrome, pancreatic
 insufficiency

 -  Use of any prescription drugs known to affect muscle mass, including androgen
 supplements, anti-androgens (such as LHRH agonists), anti-estrogens (tamoxifen, etc.)
 recombinant human growth hormone (rhGH), insulin, oral beta agonists, megestrol
 acetate, dronabinol, metformin, etc.

 -  Hemoglobin concentration below 11.0 g/dL at screening.

 -  Liver disease or liver injury.

 -  Use of other investigational drugs at the time of enrollment, or within 30 days and
 for any other limitation of participation in an investigational trial based on local
 regulations.

 -  Women of child-bearing potential.

 Other protocol-defined inclusion/exclusion criteria may apply