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ARCA biopharma, Inc. (ABIO)

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Last Post: 9/11/2019 5:58:06 PM - Followers: 109 - Board type: Free - Posts Today: 0

***These patients experienced a 74% (p = 0.0003) reduction in risk of AF versus no detectable reduction in patients who had alternative genotypes (beta1389 Gly carriers; 53% of the patients) who had received placebo. The Company believes this data supports the potential ability of Gencaro to prevent AF in patients who have the genotype the Company believes responds most favorably to Gencaro.

The Science:

GENETIC-AF Clinical Trial

GENETIC-AF is planned as a Phase 2B/3, multi-center, randomized, double-blind clinical trial comparing Gencaro to metoprolol CR/XL for prevention of AF in patients with heart failure and reduced left ventricular ejection fraction (HFREF). ARCA plans to enroll only patients with the genetic variant of the beta-1 cardiac receptor which the Company believes responds most favorably to Gencaro. GENETIC-AF has an adaptive design, under which the Company plans to initiate it as a Phase 2B study in approximately 200 patients and then, depending on the results of an interim analysis by the trial Data Safety Monitoring Board (DSMB), expand the trial to a Phase 3 study by enrolling an estimated additional 420 patients.

Under the collaboration with Medtronic, ARCA plans to conduct a substudy that will include continuous monitoring of the cardiac rhythms of all 200 patients enrolled during the Phase 2B portion of GENETIC-AF. Each patient will have heart rhythm monitoring via a Medtronic device, either a previously implanted cardiac resynchronization or defibrillation device, or a previously or newly inserted Reveal® loop recorder. The collaboration substudy will measure AF burden, defined as a patient’s actual time in AF regardless of symptoms. For the DSMB interim analysis, AF burden and the primary endpoint of the study, time to recurrence of symptomatic AF after electrical cardioversion, or death, will be reviewed by the DSMB to determine if there is sufficient potential for a statistically significant efficacy signal to be determined for all patients enrolled in the Phase 2B/3 study. 


Gencaro Data in Atrial Fibrillation

Clinical data analysis from a post-hoc review of patient forms from the from BEST trial, a Phase 3 trial in 2,708 patients with advanced heart failure, indicate that Gencaro may have a potentially enhanced and pharmacogenetically-influenced effect in reducing and preventing AF. In that trial, patients in the Gencaro arm had a reduction in the risk of new onset AF time to event compared to patients in the placebo arm of 41% (AF measured as an adverse event/serious adverse event or as detected on surveillance ECGs, time to event analysis, p = 0.0004). In a 1,040 patient DNA substudy of BEST, Gencaro exhibited potential pharmacogenetic enhancement and differentiation for AF prevention in patients with a specific genotype (beta1389 arginine homozygous (Arg/Arg) adrenergic receptor (AR); approximately 47% of the patients). These patients experienced a 74% (p = 0.0003) reduction in risk of AF versus no detectable reduction in patients who had alternative genotypes (beta1389 Gly carriers; 53% of the patients) who had received placebo. The Company believes this data supports the potential ability of Gencaro to prevent AF in patients who have the genotype the Company believes responds most favorably to Gencaro.

In prior placebo controlled trials of beta blockers in chronic HFREF, most studies comparing beta-blockers to placebo have detected a positive signal for prevention of AF, with an event rate reduction averaging approximately 27%, although AF had not been a pre-specified primary or secondary endpoint in these studies. Currently, no beta-blocker has been approved by the U.S. Food and Drug Administration for the prevention of
AF in heart failure patients.

Gencaro™ [Bucindolol Hydrochloride]
ARCA is currently developing Gencaro™ (tradename pending FDA approval) (bucindolol hydrochloride) for the prevention of atrial fibrillation and the treatment of chronic heart failure. Gencaro™ is a pharmacologically unique beta-blocker and mild vasodilator. Gencaro™ is considered part of the beta-blocker class because of its property of blocking beta-1 as well as beta-2 receptors in the heart, preventing these receptors from binding with other molecules that would otherwise activate the receptor. Because of its mild vasodilator effects, the Company believes Gencaro™ is well-tolerated in patients with advanced HF. ARCA has identified common genetic variations, or genetic markers, that it believes predict patient response to Gencaro™.

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ABIO News: Current Report Filing (8-k) 10/11/2019 04:31:12 PM
ABIO News: ARCA Biopharma President and CEO Dr. Michael Bristow to Present at HFSA 2019 Excellence in Translational Science Symposium 09/12/2019 08:30:00 AM
ABIO News: Arca Biopharma Announces Gencaro Atrial Fibrillation Clinical Data Selected for Presentation at HFSA 2019 Scientific Meeting 09/11/2019 08:30:00 AM
ABIO News: Current Report Filing (8-k) 08/01/2019 04:47:02 PM
ABIO News: ARCA biopharma Announces Second Quarter 2019 Financial Results and Provides Corporate Update 08/01/2019 04:30:00 PM
#2321   * * $ABIO Video Chart 09-11-2019 * * ClayTrader 09/11/19 05:58:06 PM
#2320   So what is wrong with this?? Anyone?? Roadtojourney 09/11/19 10:58:41 AM
#2319   * * $ABIO Video Chart 06-03-2019 * * ClayTrader 06/03/19 05:51:00 PM
#2318   $ABIO Thinking about buying stock in Arca Biopharma, SpotOnTrade 05/14/19 01:42:07 PM
#2317   ABIO > 18.50 in PM. crudeoil24 05/09/19 07:22:25 AM
#2316   $ABIO - nice action yesterday and pre-market today. LodieJ 05/08/19 09:13:05 AM
#2314   What is your proof there is a short I-Glow 05/06/19 01:28:10 PM
#2313   There is no share offering yet. We would LodieJ 05/05/19 09:28:15 AM
#2312   I called a $10/share offering when this was RealLovePipes 05/03/19 10:54:31 AM
#2311   ABIO buy 10.74 stocktrademan 05/03/19 10:18:10 AM
#2310   This one I expect an offering announcement soon RealLovePipes 05/03/19 09:58:30 AM
#2309   Wrong board sorry RealLovePipes 05/03/19 09:57:50 AM
#2308   Up 3% and climbing! Rally underway RealLovePipes 05/03/19 09:49:46 AM
#2307   My best pick for today is X US STEEL. dinogreeves 05/03/19 07:39:44 AM
#2306   Yesterday went as high as 20.00 sold that dinogreeves 05/03/19 07:23:32 AM
#2305   and is getting a lot cheaper. wasn't this Rocketstockpix 05/03/19 07:01:36 AM
#2304   Well for one, I think it's too soon LodieJ 05/02/19 11:04:48 PM
#2303   Can you explain how an offering would affect fahrenheitjules 05/02/19 10:46:40 PM
#2302   * * $ABIO Video Chart 05-02-2019 * * ClayTrader 05/02/19 04:28:57 PM
#2301   Danger of offering AH I wouldn’t hold personally RealLovePipes 05/02/19 03:44:01 PM
#2300   Just found this one today. Looking at an fahrenheitjules 05/02/19 02:34:34 PM
#2299   This thing can’t hold any upward momentum. JJGl 05/02/19 12:28:52 PM
#2298   Still holding here. Missed that $20 this morning LodieJ 05/02/19 11:49:32 AM
#2297   I predict an offering at $10 RealLovePipes 05/02/19 11:01:35 AM
#2296   ^$ ~MulaGreen~ 05/02/19 10:54:01 AM
#2295   Won’t they do an offering now? Announced AH? RealLovePipes 05/02/19 10:43:31 AM
#2294   $16.25 nice :) wesley_ 05/02/19 10:42:24 AM
#2293   Textbook BPT$ pattern washed out all the weak, dinogreeves 05/02/19 10:37:44 AM
#2292   How accurate am I? Makk1 05/02/19 10:01:51 AM
#2291   lol premarket shake and bake. Love short squeezes DarkPool 05/02/19 09:55:54 AM
#2290   haltd karimo 05/02/19 09:53:30 AM
#2289   This will halt at some point. Going nuts!! BillG2436 05/02/19 09:31:44 AM
#2288   This has been more fun than Mary Jane..... davidsson10 05/02/19 09:16:22 AM
#2287   Got in at $11.59 yesterday, put a sell UKdude 05/02/19 09:13:57 AM
#2286   Start 15$ ??? + ollik78 05/02/19 09:04:48 AM
#2285   Squeeze!! ABIO Lone Wolf 05/02/19 09:04:07 AM
#2284   Damn, was going to buy PM in low BillG2436 05/02/19 08:59:39 AM
#2283   Pow pow pow Awl416 05/02/19 08:43:16 AM
#2282   Squeeze stock1ace1 05/02/19 07:43:18 AM
#2281   What happen today?? ollik78 05/02/19 06:42:04 AM
#2280   (((((KABOOMAGE)))))!! 2.0 halpern6 05/02/19 05:34:59 AM
#2279   ABIO LOVE YOU!!!! MBD makingbiigdough 05/01/19 10:56:48 PM
#2278   $ABIO ARCA bio up 36% on "positive" bucindolol data $Pistol Pete$ 05/01/19 07:21:14 PM
#2277   Shake and bake! DarkPool 05/01/19 06:43:49 PM
#2276   Idea what will happen tomorrow ... ollik78 05/01/19 05:36:28 PM
#2275   wow. what a move today on massive volume Rocketstockpix 05/01/19 05:35:15 PM
#2274   Surprised there wasn’t an offering. But, good day Full Contact Yoga 05/01/19 05:14:36 PM
#2273   One seriously undervalued stock. dinogreeves 05/01/19 05:10:42 PM
#2272   * * $ABIO Video Chart 05-01-2019 * * ClayTrader 05/01/19 04:17:52 PM
#2271   Exactly, there is that very common risk with crudeoil24 05/01/19 03:50:43 PM