Phase I

Amyndas Pharmaceuticals Inc., of Philadelphia

AMY-101

C3-targeted complement inhibitor

Complement-mediated conditions

AMY-101 had a good safety profile in healthy male volunteers administered single and multiple doses; pharmacokinetic and pharmacodynamic characteristics support subcutaneous dosing every 48 hours

Combioxin SA, of Geneva

CAL-02

Broad-spectrum antitoxin

Community-acquired pneumonia

Completed first-in-man trial, with the independent data monitoring committee supporting a positive safety profile at both dosing regimens in patients with severe CAPB due to Streptococcus pneumoniae

Phase II

Immunovaccine Inc., of Halifax, Nova Scotia

DPX-Survivac

Survivin-based peptide antigens

Diffuse large B-cell lymphoma

Initiated patient dosing in investigator-sponsored trial in combination with pembrolizumab (Keytruda, Merck & Co. Inc.)

Mimedx Group Inc., of Marietta, Ga.

Amniofix

Composite amniotic tissue membrane

Osteoarthritis of the knee

Enrolled first patient in prospective, double-blind, randomized, controlled phase IIb study

Phase III

Alnylam Pharmaceuticals Inc., of Cambridge, Mass.

Patisiran

RNAi therapeutic

Hereditary ATTR amyloidosis

Patisiran demonstrated improvement of cardiomyopathy in prospectively defined subgroup of patients with cardiac amyloid involvement, relative to placebo

Brainstorm Cell Therapeutics Inc., of New York

Nurown

Cell therapy

Amyotrophic lateral sclerosis

Amended protocol so that Canada-based patients can enter

Cytori Therapeutics Inc., of San Diego

Cytori Cell Therapy

Adipose-derived regenerative cells

Stress urinary incontinence due to prostate intervention

Full enrollment was reached in the 45-patient ADRESU investigator-initiated trial in Japan

Edge Therapeutics Inc.

EG-1962

Nimodipine microcapsules

Aneurysmal subarachnoid hemorrhage

Discontinued on advice from data monitoring committee

Urovant Sciences

Vibegron

Oral β3-adrenergic agonist

Overactive bladder

Started EMPOWUR trial

Wize Pharma Inc., of Hod Hasharon, Israel

LO2-A

Sodium hyaluronate

Dry eye syndrome

Enrolled the first patient in a phase IV trial to treat dry eye syndrome in patients with Sjogren's syndrome vs. Systane Ultra UD eye drop

Notes

For more information about individual companies and/or products, see Cortellis.