Company |
Product |
Description |
Indication |
Status |
Phase I | ||||
Cyclacel Pharmaceuticals Inc., of Berkeley Heights, N.J. |
Sapacitabine |
CDK inhibitor |
BRCA-mutant breast cancer |
Initiated phase Ib/II trial testing sapacitabine in combination with PARP inhibitor Lynparza (olaparib, Astrazeneca plc); about 64 patients will be enrolled, and primary endpoints will determine maximum tolerated dose, recommended phase II dose and objective response rate |
Designmedix Inc., of Portland, Ore. |
DM-1157 |
Reversed chloroquine antimalarial compound |
Malaria |
Administered drug to the first cohort of volunteers to assess safety and ability to be absorbed |
Five Prime Therapeutics Inc., of South San Francisco |
Bemarituzumab (FPA-144) |
Isoform-selective anti-FGF receptor antibody |
Advanced gastric cancer or gastroesophageal junction cancer |
Completed phase I safety lead-in portion and initiated phase III portion of the FIGHT phase I/III trial testing bemarituzumab in combination with chemotherapy vs. placebo plus chemo in patients with previously untreated disease; about 550 patients will be enrolled, and primary endpoint is overall survival; secondary endpoints are progression-free survival, objective response, safety and pharmacokinetic parameters |
Tracon Pharmaceuticals Inc., of San Diego |
TRC-105 |
Antibody to endoglin |
Advanced or metastatic renal cell carcinoma |
Phase Ib results published in The Oncologist showed TRC-105 plus Inlyta (axitinib, Pfizer Inc.) resulted in objective response rate of 29% and stable disease rate of 59%, for an overall disease control rate of 88% (15 of 17 patients); median progression-free survival was 11.3 months |
Phase II | ||||
Acadia Pharmaceuticals Inc., of San Diego |
Pimavanserin |
Serotonin 2A receptor inverse agonist |
Alzheimer's disease psychosis |
Results published in The Journal of Prevention of Alzheimer's Disease showed that in a subgroup of patients with more severe delusions and hallucinations, the drug demonstrated significant improvement relative to placebo with a similar and acceptable tolerability profile |
Flexion Therapeutics Inc., of Burlington, Mass. |
Zilretta (triamcinolone acetonide extended-release injectable suspension) |
Short-acting corticosteroid |
Osteoarthritis knee pain in patients with type 2 diabetes |
Data published in Rheumatology showed the trial met its primary endpoint, demonstrating the change in blood glucose levels was significantly lower following Zilretta vs. immediate-release triamcinolone acetonide in crystalline suspension (TAcs); change in average daily glucose levels in the 72 hours following injections showed a difference of 19.2mg/dL (p=0.0452); blood glucose increase after injection was statistically significant in those treated with TAcs (p=0.0354), but not in those on Zilretta (p=0.6665) |
Phase III | ||||
Sumitomo Dainippon Pharma Co. Ltd., of Osaka, Japan |
Lonasen (blonanserin) |
Atypical antipsychotic in a transdermal patch formulation |
Acute schizophrenia |
Data from 577 patients in the primary analysis population showed significant reductions in baseline to week 6 in Positive and Negative Syndrome Scale (PANSS) total score at both 40-mg/day and 80-mg/day dose groups vs. placebo; long-term study data showed the mean PANSS score was generally stable during the treatment period vs. baseline, and no deterioration was observed for psychological symptoms |
Phase IV | ||||
Eli Lilly and Co., of Indianapolis |
Taltz (ixekizumab) |
IL-17 inhibitor |
Moderate to severe plaque psoriasis |
Initiated IXORA-R study as a head-to-head trial testing Taltz and IL-23-targeting Tremfya (guselkumab, Johnson & Johnson), using the Psoriasis Area Severity Index 100 score as the primary endpoint; a total of 960 patients will be enrolled |
Notes For more information about individual companies and/or products, see Cortellis. |