BYM338 in Chronic Obstructive Pulmonary Disease (COPD) Patients With Cachexia

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