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ARCA biopharma, Inc. (ABIO)

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Last Post: 7/29/2020 11:32:24 AM - Followers: 115 - 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) 08/05/2020 04:32:04 PM
ABIO News: Arca Biopharma Announces Second Quarter 2020 Financial Results and Provides Corporate Update 08/05/2020 04:15:10 PM
ABIO News: Quarterly Report (10-q) 08/05/2020 04:07:16 PM
ABIO News: Prospectus Filed Pursuant to Rule 424(b)(5) (424b5) 07/22/2020 04:34:21 PM
ABIO News: Current Report Filing (8-k) 07/22/2020 04:10:57 PM
PostSubject
#2377   $7 CrazyMoney101 07/29/20 11:32:24 AM
#2376   Good calls on VVUSQ fwiw... okavango 07/22/20 09:21:52 PM
#2375   Opened a starter position today at $7.30. llcoolm11 07/22/20 05:23:37 PM
#2374   Great setup abio$7.88 stock1ace1 07/20/20 03:14:53 PM
#2373   Looks good! Golden_Cross 07/20/20 03:14:51 PM
#2372   1 mill float ! stock1ace1 07/20/20 03:14:11 PM
#2371   We have a new Drug for Investors AB2020 Popcorncharts 07/15/20 05:53:29 AM
#2370   WARNING FOR THIS SCAM! EBOLA SCAM COVID SCAM Popcorncharts 07/14/20 08:16:44 PM
#2369   Scam new dilut 50% Long Investor lose 99.9% Popcorncharts 07/14/20 07:26:44 PM
#2368   Long Investors lose all Money ! Management dilut Popcorncharts 07/14/20 06:43:11 PM
#2367   INVESTING WARNING THIS SCAM HAVE NOT COVID-19 pipelines! Popcorncharts 07/13/20 05:29:08 PM
#2366   Bouncing here...hee haw Golden_Cross 07/07/20 12:35:35 PM
#2365   Got 8,70,s europtiger 06/10/20 03:27:01 PM
#2364   Thx for heads up... buying some 8,80‘s europtiger 06/10/20 03:23:11 PM
#2363   https://ih.advfn.com/stock-market/NASDAQ/arca-biopharma-ABIO/stock-news/82636540 [SMART MONEY] 06/10/20 03:21:38 PM
#2362   Great call! Pennsy 06/01/20 09:48:24 PM
#2361   It is so funny the MMs behave so RAlbert 06/01/20 08:40:52 AM
#2360   https://elemental.medium.com/coronavirus-may-be-a-blood-vessel-disease-which-exp Sy-ATDS 05/30/20 10:19:55 PM
#2359   Nice find Chessmaster. Thank you for posting. BugStocks_com 05/29/20 01:54:40 PM
#2358   Great Article ABIO https://emerginggrowth.com/arca-biopharma-nasdaq-abio-nearly- Chess Master 05/29/20 01:42:55 PM
#2357   Lk May run today atos anytime it can akamaii 05/29/20 11:50:41 AM
#2356   True, but when something spikes like that it NewMoney 05/29/20 11:49:17 AM
#2355   There must be a reason it went up Sy-ATDS 05/29/20 10:22:43 AM
#2354   Put alert at around 250 when she hits akamaii 05/29/20 09:36:11 AM
#2353   They're gonna gap it down hard today it NewMoney 05/29/20 09:19:24 AM
#2352   damn look at that volume definitely a short enthalpy 05/29/20 05:54:42 AM
#2351   Go to atos sympathy play to this fda akamaii 05/28/20 11:53:22 PM
#2350   * * $ABIO Video Chart 05-28-2020 * * ClayTrader 05/28/20 04:55:11 PM
#2349   Nice pop today Wondering any offering tmrw? Volcano 05/28/20 04:31:42 PM
#2348   yes! [SMART MONEY] 05/28/20 04:28:22 PM
#2347   Wow congrats on the beginning of a MOASS Wall $treet Kid 05/28/20 03:51:23 PM
#2346   Are u selling? europtiger 05/28/20 03:50:07 PM
#2345   ABIO $21'S [SMART MONEY] 05/28/20 03:44:31 PM
#2344   Congrats to the folks in before today. WOW! NewMoney 05/28/20 03:07:22 PM
#2343   Hell yeah. Watch for the secondary offering. DarkPool 05/28/20 03:05:42 PM
#2342   Congrats ! MilitaryDeals 05/28/20 02:52:14 PM
#2341   Holy crap I’m up over 60% already. I’m NewMoney 05/28/20 02:44:56 PM
#2340   Don’t know where this will end today... but europtiger 05/28/20 02:04:37 PM
#2339   Wooowzaaaa well done buddy!!! europtiger 05/28/20 01:46:35 PM
#2338   ABIO 14.50!!! [SMART MONEY] 05/28/20 01:45:39 PM
#2337   I caught some @ 10.65 on the dip [SMART MONEY] 05/28/20 01:24:47 PM
#2336   Hmmmm,imo down from here at 11,70 europtiger 05/28/20 12:40:19 PM
#2335   Buy the dip. NewMoney 05/28/20 12:39:35 PM
#2334   What a crazy day - still should get Toddrobertking 05/28/20 12:24:57 PM
#2333   ABIO $13.50 now that was crazy [SMART MONEY] 05/28/20 11:32:54 AM
#2332   Ok, I couldn't help but chase the momo NewMoney 05/28/20 11:00:17 AM
#2331   ABIO Now in the $12. WOW swanlinbar 05/28/20 10:49:24 AM
#2330   Now going Crazy europtiger 05/28/20 10:39:04 AM
#2329   208% now woooowzaaa europtiger 05/28/20 10:38:36 AM
#2328   Up 180% on the day. Damn, missed that NewMoney 05/28/20 10:24:01 AM
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