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

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