Cytokinetics, Seagen, Concert and Idorsia Begin Week with Trial Wins

Several biopharma companies opened the week with positive clinical trial news. Read on for updates from Cytokinetics, Concert Pharmaceuticals, Idorsia and Seagen.

Cytokinetics Shares Positive Data for Cardiologic Conditions

Cytokinetics presented and shared data relating to aficamten and omecamtiv mecarbil at Heart Failure 2022, an International Congress of the European Society of Cardiology meeting. Aficamten is intended for the treatment of hypertrophic cardiomyopathies, specifically symptomatic obstructive hypertrophic cardiomyopathy (oHCM), while omecamtiv mecarbil is intended to treat heart failure with reduced ejection fraction (HFrEF) and low blood pressure.

Analyses of aficamten showed that ongoing treatment resulted in sustained and substantial reductions in left ventricular outflow tract gradients, which measures systolic function and cardiac output. Patients treated also had significant improvements in cardiac biomarkers and was well-tolerated.

Results from the treatment of low blood pressure patients with omecamtiv mecarbil had an increased treatment effect which resulted in a decreased risk of heart failure or cardiovascular death, which all patients in the study with low blood pressure were at risk of. Patients with low blood pressure also experienced improvements in blood pressure over time.

Seagen Moves Forward with Positive Data for Colorectal Cancer Drug

Seagen announced positive data from the pivotal Phase II clinical trial of Tukysa (tucatinib) in combination with trastuzumab. The combinatorial therapy is intended to treat HER2-positive metastatic colorectal cancer (mCRC).

Results from the trial, which was made up of 117 patients, showcased anti-tumor activity. Treatment with the therapy resulted in a 38.1% objective response rate with a median duration of response being 12.4 months. The combinatorial therapy was also generally well-tolerated with treatment-emergent adverse events including diarrhea, fatigue and nausea.

Based on the data, Seagen plans to engage in regulatory discussions with the U.S. Food and Drug Administration with the intent to submit a new drug application (NDA). Merck is commercializing Tukysa in regions outside of the U.S., Canada and Europe, and plans to utilize the data in discussions with health authorities in its territory.

Concert Pharma Sings Phase III Data for Alopecia Areata Treatment

Concert Pharmaceuticals announced positive topline results from its Phase III clinical trial of CTP-543 for the treatment of alopecia areata. Alopecia areata is an autoimmune disease that results in patchy or complete scalp hair loss.

Results showed that in patients with moderate to severe alopecia areata, treatment with CTP-543 caused a statistically significant proportion of patients to experience greater scalp regrowth as compared to those treated with placebo. 41.5% of patients in the higher-dosage group experienced 80% or more scalp hair coverage as compared to 0.8% of patients in the placebo group.

The safety profile was consistent with previous studies of the drug with the most common side effects including headache, acne, upper respiratory infection and nasopharyngitis. Concert plans to submit the results for publication and are intended to form the basis for an NDA in the first half of 2023.

Idorsia Announces Positive Data for Antihypertension Drug

Idorsia announced top-line results from its Phase III clinical trial of aprocitentan for the treatment of patients whose blood pressure is not adequately controlled, even after receiving triple antihypertensive therapy, which is known as resistant hypertension.

Results demonstrated that aprocitentan significantly reduced blood pressure when added to standardized combination background antihypertensive therapy over 48 weeks of treatment. The therapeutic was able to reduce blood pressure by week four of treatment and was generally well tolerated with no major safety concerns.

Idorsia plans to discuss the results with health authorities with the aim to file an NDA with the FDA by the end of the year.