Open Label Safety and Tolerability Study of COV155 in Subjects With Osteoarthritis (OA) or Chronic Low Back Pain (CLBP)

Inclusion Criteria

- General good health, other than osteoarthritis (OA) or chronic low back pain (CLBP),
based upon results of medical and surgical history and medical exam

- ≥18 years of age

- Voluntarily provide written informed consent

- Female subjects eligible if

1. Not pregnant or lactating; not planning to become pregnant within next 60 days

2. Surgically sterile, or 2 years postmenopausal, or practicing acceptable birth
control for more than 60 days prior to Screening and use of acceptable birth
control during the study and 7 days following the last dose of COV155

- Male subjects biologically capable of having children must use reliable birth control
during study and 7 days after the last dose of COV155. Surgical sterilization of the
subject's monogamous partner qualifies as adequate birth control

- Clinical diagnosis of one of the following

1. OA of knee or hip for at least 1 year with moderate to severe daily pain despite
chronic use of stable doses of non-steroidal anti-inflammatory drugs (NSAIDs) or
other non-steroidal, non-opioid therapies or with therapy including opioids

2. Moderate to severe CLBP for at least several hours a day for a minimum of 90
days, not due to a known malignancy, and classified as non-neuropathic,
neuropathic, or symptomatic for more than 6 months after LBP surgery

- Average in-clinic pain score of ≥3 on 11-point (0 to 10) numerical rating scale (NRS)
as an average for the last 24 hours at Screening

- Pain intensity score of ≥4 on NRS as an average for the last 24 hours at Baseline

Exclusion Criteria

- Any clinically significant condition or unstable illness that precludes study
participation or interferes with assessment of pain and other symptoms of CLBP or OA
or would increase the risk of opioid or NSAID related adverse events

- Schizophrenia or an uncontrolled or poorly controlled major psychiatric condition or
clinically significant anxiety or depression

- Active malignancy or history of malignancy within 2 years prior to Screening other
than dermal or cervical squamous cell carcinoma in situ

- History of seizures (exception-pediatric febrile seizures)

- Clinically significant ECG abnormalities or uncontrolled hypo- or hypertension

- Arthroscopic or open surgery on either the knee or hip selected as primary OA study
joint within 6 months prior to Screening

- For CLBP subjects, a surgical procedure for back pain within 6 months prior to
Screening, nerve or plexus block within 30 days prior to Screening or botulinum toxin
injection in lower back region within 90 days prior to Screening. For OA subjects,
joint injection within 30 days prior to Screening

- Surgical implants of either the knee or hip selected as the primary OA joint

- Gastric reduction or gastric band surgery

- Taking opioids in equivalents to more than 20 mg hydrocodone or more than 40 mg
morphine orally per day, or taking opioid medications 4 days a week or more

- Known allergy or hypersensitivity to opioids, acetaminophen or ibuprofen

- Certain lab abnormalities

- Unable to discontinue use of prohibited medications or history of substance or
alcohol abuse within 2 years prior to Screening or positive urine drug test at
Screening for alcohol, illicit drugs (including medical cannabis) or controlled
substances other than prescribed medications

- Positive for human immunodeficiency virus, hepatitis B (surface antigen), and/or
hepatitis C

- Any other chronic pain condition other than CLBP or OA that would interfere with the
assessment of CLBP or OA

- Used a monoamine oxidase inhibitor, antipsychotic, or benzodiazepine within 14 days
prior to Screening or started or changed doses of anticonvulsants, selective
serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, or
tricyclic antidepressants within 30 days prior to Screening

- Previously received COV155 in a study

- Received any investigational drugs or devices within 30 days prior to Screening

- Other criteria as specified in the protocol