Arca Biopharma (ABIO) to develop a coronavirus treatment

 

Arca said it will study an experimental drug called AB201 in patients with Covid-19 and abnormal blood clotting. Abnormal blood clotting is one of the serious complications of Covid-19. Arca has already tested AB201 in more than 700 patients with other conditions.

The drug already has "substantial safety data, which the company believes may enable more rapid development," Arca said in a news release. The biotech company plans to ask the Food and Drug Administration for permission to begin testing as a coronavirus treatment during the third quarter.

Why It Could Work In Coronavirus Treatment
Arca's potential coronavirus treatment works by blocking the tissue factor, or TF, protein, which is tied to the inflammatory response to viral infections. The biotech company has already studied AB201 in more than 700 patients for various conditions in Phase 1 and Phase 2 tests.

Recent research suggests Covid-19 has several factors in common with blood disorders in which the blood's ability to clot has been impaired, Arca said. There's also evidence to indicate AB201 could have natural and anti-inflammatory abilities, the company said.

"Collectively, the company believes these observation provide a strong rationale for investigating AB201 as a treatment for Covid-19, the disease caused by SARS-CoV-2 virus," Arca said.

The need for an effective coronavirus treatment continues to grow alongside the number of cases. As of Thursday morning, there were more than 5.8 million confirmed cases of Covid-19 globally. The U.S. accounts for about 30% of the caseload.

ARCA biopharma (ABIO) : underwhelming mid-stage Gencaro data

• Headquarters: Westminster, CO
• Founded: 1992
• arcabio.com

  

ARCA biopharma announces clinical results from GENETIC-AF -- Gencaro demonstrated a similar treatment benefit compared to the active control 

The co announced clinical results from GENETIC-AF, a Phase 2B, double-blind, superiority clinical trial evaluating GencaroTM (bucindolol hydrochloride) as a genetically-targeted treatment for atrial fibrillation (AF) in patients with heart failure and reduced left ventricular ejection fraction (HFrEF). In all patients, Gencaro demonstrated a similar treatment benefit compared to the active control, metoprolol succinate (TOPROL-XL). In U.S. patients (127 of 267 total patients), a trend for potential superior benefit in favor of Gencaro (approximately 30% risk reduction over TOPROL-XL), was observed for the primary endpoint of time to recurrence of AF. Additionally, in U.S. patients, Gencaro demonstrated a trend for potential superior benefit in favor of Gencaro (approximately 51% risk reduction over TOPROL-XL) in a subset of patients who underwent continuous heart rhythm monitoring with Medtronic implanted devices. Safety data indicated that Gencaro was generally safe and well-tolerated in the AF/heart failure (HF) population investigated with a safety profile similar to TOPROL-XL.

• In all patients, Gencaro demonstrated a similar treatment benefit compared to the active control, TOPROL-XL (143 total events, hazard ratio of 1.01 (95% confidence interval: 0.71, 1.42), which was associated with a PPoS of 14%. In the U.S. patient cohort of 127 patients (approximately 50% of all patients and events), a trend for potential superior benefit in favor of Gencaro over TOPROL-XL was observed (73 events, hazard ratio 0.70, [95% confidence interval: 0.41, 1.19]), with a PPoS of 61%, which was greater than the prespecified criteria set by the company to proceed to Phase 3 development. The Company believes the difference in treatment effects between the overall and U.S. patient cohorts was primarily due to results in two non-U.S. countries exhibiting hazard ratios >1.0. The differences between patients enrolled at these sites versus the U.S. and other country cohorts are being investigated.
• Gencaro was generally safe and well-tolerated, with 84% of patients attaining their target dose compared to 72% of patients receiving TOPROL-XL. The most frequently reported adverse events were similar in both groups and consistent with the known safety profile of the beta-blocker class of drugs. Adverse events assessed as related to study drug by the investigator occurred in 23.8% of patients in the Gencaro group and in 30.1% of patients in the TOPROL-XL group. Of note, adverse events of bradycardia were less frequently reported in the Gencaro group (3.7%) compared to patients receiving TOPROL-XL (12.0%). During the 24-week efficacy follow-up period there were three deaths (ACM) in the TOPROL-XL group and none in the Gencaro group. Three patients died in the long-term treatment extension period after receiving Gencaro for more than a year.
• ARCA anticipates meeting with the U.S. Food and Drug Administration (FDA) in the second quarter of 2018 to review Gencaro Phase 2 data and potential Phase 3 development plan.