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Cara Therapeutics, Inc. (CARA)

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Company Description: Cara Therapeutics is an emerging biotechnology company focused on developing novel therapeutics to treat human diseases associated with pain and inflammation. Cara possesses both near-term clinical development opportunities combined with proprietary approaches to developing first-in-class novel therapeutics. Cara's most advanced patented compound, CR845, is currently undergoing clinical testing for acute pain. This compound possesses analgesic and anti-inflammatory activities appropriate for multiple therapeutic applications. In addition, Cara aims to develop a future pipeline of first-in-class molecules at novel analgesic and anti-inflammatory targets using its proprietary drug screening technology.

Intellectual property: CR845 was discovered by CARA's scientists. CARA owns six U.S. patents pertaining to CR845  with claims covering compositions of matter and methods of use for CR845. The earliest U.S. patent claiming CR845 compositions will expire no earlier than November 12, 2027. To date CARA has built an extensive patent portfolio with 58 patents issued and 72 pending.

Pipeline and Technologies: CR845 has completed three Phase 2 clinical trials in acute post-operative pain. Cara's most advanced CB compound, CR701, is in preclinical development.





CB Antagonists: Studies on the effects of cannabis have led to the discovery of an endogenous system of ligands involved in pain and inflammation. The main naturally occurring ligands for this system, anandamide and 2-arachidonoylglycerol (2-AG), activate a number of cannabinoid receptors, including CB1 and CB2 receptors. Like opioid receptors, CB1 and CB2 receptors are members of the G protein-coupled receptor superfamily. CB1 receptors and associated ligands are mainly localized in the brain whereas CB2 receptors are found mainly in peripheral tissues, particularly immune cells such as leukocytes and mast cells, which have been shown to be involved in pain and inflammatory responses. Cara is developing lead molecules that selectively modulate peripheral CB receptors without targeting CNS cannabinoid receptors. Peripheral CB receptor modulators will be initially developed as a novel therapeutic approach for neuropathic pain, a condition currently without consistently effective therapies.

Revenue from License Agreements: All of CARA's revenue to date has been from license agreements. They have received aggregate payments of $28.8 million pursuant to license agreements related to CR845. In April 2013, CARA entered into a license agreement with Maruishi under which CARA granted Maruishi an exclusive license to develop, manufacture and commercialize drug products containing CR845 in Japan in the acute pain and uremic pruritus fields.

Under the terms of the agreement, CARA received a non-refundable and non-creditable upfront license fee of $15.0 million and is eligible to receive an aggregate of $6 million in clinical development milestones and $4.5 million in regulatory milestones. CARA is also eligible to receive tiered royalties, with percentages ranging from the low double-digits to the low twenties, based on net sales of products containing CR845 in Japan, if any, and share in any sub-license fees.

Use of Proceeds: CARA expects to net $52.9 million from its IPO. Proceeds are allocated as follows: $44 million to conduct its planned Phase 3 clinical trials and other development activities for I.V. CR845 $2.1 million to conduct its planned Phase 1 clinical trial for Oral CR845 $4.6 million to conduct its planned Phase 2a clinical trials and other development activities for Oral CR845; and the remainder for working capital and other general corporate purposes.
 
 

PIPELINE & TECHNOLOGIES






ClinicalTrials.gov
A service of the U.S. National Institutes of Health

 
Find Studies:

https://clinicaltrials.gov/ct2/results?term=CR845&Search=Search


 


KAPPA RECEPTOR AGONISTS

Opiate analgesics can act through three different types of opioid receptors, called mu, delta, and kappa. Morphine, the most widely used opiate analgesic, acts primarily via activation of the mu opioid receptor located in the central nervous system (CNS).

This CNS action induces pain relief but is also associated with a wide array of CNS-mediated side effects including sedation, respiratory depression, and abuse liability. As a way to avoid these undesirable CNS effects, there has been an effort to develop opioids which activate peripheral opioid receptors present on sensory nerves, but are also largely excluded from the brain. Such compounds are thought to have the potential to provide pain relief (peripheral opioid analgesia) without producing significant CNS side effects. CR845 belongs to this pharmacological class of compounds; it is a potent peripheral kappa opioid receptor agonist with high selectivity over other opioid receptors.

CR845 has completed three Phase 2 clinical trials in acute post-operative pain.
 


 

CR845

Cara possesses peripherally-selective molecules that interact with kappa opioid receptors present on peripheral, pain-sensing nerves.

These compounds exhibit potent analgesic and anti-inflammatory properties in animals. Unlike currently marketed opioids, these new compounds do not produce inhibition of intestinal transit (ileus), do not induce life-threatening respiratory depression, nor do they elicit signs of addiction or euphoria in animal models.

The degree of kappa receptor selectivity displayed by CR845 ranks as best-in-class compared to all other previously developed compounds for this therapeutic target. Moreover, CR845 displayed no significant affinity for any other non-opioid known receptors.
 


 

CR845 & OTHER KAPPA AGONISTS

Cara has developed two peripheral kappa agonists, CR845 and CR665, which display unmatched peripheral selectivity in animal models when compared to first generation kappa compounds.

Both compounds are intrinsically poor at penetrating the blood-brain barrier which decreases the likelihood of CNS-mediated side effects. The peripheral selectivity of CR665 was evaluated in rodents by comparing the 50% effective dose (i.e., A 50 value) to reduce viscero-somatic pain versus the 50% effective dose to induce a CNS-mediated effect. Pain was measured by the number of writhing movements after administration of an irritant into the abdomen, while the CNS effects were determined by impairment of motor coordination (inability to balance on a rotating horizontal rod). As shown (figure), previously developed kappa agonists such as enadoline, asimadoline, and TRK-820 inhibited the pain response at doses only 2- to 8-fold less than those producing an impairment of motor coordination in rodents. CR665, in contrast, showed a much larger safety margin with greater than 500-fold separation of doses required to produce analgesia versus CNS side effect.

Kappa Agonists                                                                                                         Preipheral Selectivity of CR665

 


CB AGONISTS

Studies on the effects of cannabis (marijuana) have led to the recent discovery of an endogenous system of ligands in humans involved in a number of physiological processes including pain and inflammation.

The main naturally occurring ligands for this system, anandamide and 2-arachidonoylglycerol (2-AG), activate a number of cannabinoid receptors, including CB1 and CB2 receptors. Like opioid receptors, CB1 and CB2 receptors are members of the G protein-coupled receptor superfamily. CB1 receptors and associated ligands are mainly localized in the brain whereas CB2 receptors are found mainly in peripheral tissues, particularly immune cells such as leukocytes and mast cells, which have been shown to be involved in pain and inflammatory responses. Cara is developing lead molecules that selectively modulate peripheral CB receptors without targeting CNS cannabinoid receptors. Peripheral CB receptor modulators will be initially developed as a novel therapeutic approach for neuropathic pain, a condition currently without consistently effective therapies.

Cara's most advanced CB compound, CR701, is in preclinical development.

 
 

CR701

CR701 has been evaluated in a rodent model of neuropathic pain that produces both hyperalgesia (sensitization of nerve endings to painful stimuli) and allodynia (painful perception of innocuous stimuli) comparable to human conditions. As shown in the figure below, administration of CR701 to animals with neuropathy resulted in significant reversal of both hyperalgesia and allodynia, as measured by responses to thermal and tactile stimuli, respectively.

CB701                                                                                                                                                                  Reversal of Neurpathic Pain Symptoms by CR701

 


DimerScreen Technology

The most successful and therapeutically useful drug targets in modern medicine are a superfamily of membrane proteins, the G protein-coupled receptors (GPCRs).

This is particularly evident within the pain markets where all of today's clinically effective opioid analgesics and a number of anti-inflammatory agents, such as the leukotriene antagonists, act through this class of receptor protein.

In recent years, studies have demonstrated that GPCRs can form paired protein complexes - dimers - with other GPCRs on the cell surface. Two of the same GPCRs can pair up to form a homodimer , or two different GPCRs can pair up to form a heterodimer. Compared to the GPCR monomers, some of these receptor dimers display new, unexpected drug recognition and response properties, which means that there exists a broad, new array of unexplored drug targets within the GPCR superfamily.

DimerScreen™, is designed to specifically and selectively identify molecules interacting with GPCR dimers and thus allows for the discovery of compounds with new pharmacological properties at identified dimeric drug targets.

 

Upcoming Projected Clinical Milestones 2016

Reinitiate CLIN3001 Abdominal Pain Trial Q2, 2016

Initiation Uremic Pruritus Phase 2/3 Program Q2, 2016

Initiation 2nd Phase 3 Acute Pain Trial 2H, 2016

Initiation Phase 2b Oral OA Trial 2H, 2016

 
 

Novel Peripheral Kappa Opioid Product Candidates: Efficacy Without Opioid Side Effects
 
http://files.shareholder.com/downloads/AMDA-2C4IM7/1922207038x0x885511/AB0DDDC1-F921-49C7-9D9C-5665E055FAE5/Needham_2016_CARA.pdf

 

Consensus Ratings for Cara Therapeutics (NASDAQ:CARA)
 
Ratings Breakdown: 6 Buy Rating(s)
Consensus Rating: Buy (Score: 3.00)
Consensus Price Target: $23.83 (265.54% upside)


Analysts' Ratings History for Cara Therapeutics (NASDAQ:CARA)
 
 
Date Firm Action Rating Price Target  
4/23/2016 Piper Jaffray Reiterated Rating Overweight $23.00  
4/21/2016 Needham & Company LLC Reiterated Rating Buy    
4/20/2016 Cantor Fitzgerald Reiterated Rating Buy    
3/12/2016 Janney Montgomery Scott Reiterated Rating Buy $23.00 -> $18.00  
2/29/2016 Laidlaw Lower Price Target Buy $30.00 -> $17.00  
11/11/2015 Canaccord Genuity Reiterated Rating Buy $30.00  
3/3/2015 MLV & Co. Initiated Coverage Buy $26.00  
12/9/2014 Summer Street Initiated Coverage Buy $20.00  
(Data available from 4/29/2014 forward)

 
   
http://www.caratherapeutics.com/
Start with investors link.





 


Cara Therapeutics Inc. (NASDAQ:CARA)

Q1 2016 Results Earnings Conference Call

May 5, 2016 04:30 PM ET


seekingalpha.com/article/...rnings-call-transcript?part=single

 

Cara Therapeutics Is Feeling The Pain; But Not For Long

Jun. 2, 2016 3:15 AM ET

http://seekingalpha.com/article/3979324-cara-therapeutics-feeling-pain-long
 



Post-op pain treatment is ~$9B market; if CR845 pulls even 5% that's approx $450M rev.


http://seekingalpha.com/article/3977994-biotech-2-attractive-buyout-targets-7-share

 
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CARA News: Cara Therapeutics Announces Closing of Its Public Offering of Common Stock and Full Exercise of Underwriters’ Option to Pur... 04/05/2017 04:01:00 PM
CARA News: Current Report Filing (8-k) 04/03/2017 05:29:51 PM
CARA News: Statement of Changes in Beneficial Ownership (4) 04/03/2017 09:20:34 AM
CARA News: Prospectus Filed Pursuant to Rule 424(b)(5) (424b5) 03/31/2017 04:03:14 PM
CARA News: Pain-Reducing Combination Therapies Proving Successful thanks to Innovative, Specialty Pharma Players 03/30/2017 08:30:00 AM
PostSubject
#1197   Lot's of insty buying of $CARA. Hate to djmurdock 04/22/17 11:55:41 AM
#1196   Agree! Add more BurntNAlive 04/21/17 10:30:06 PM
#1195   https://www.fool.com/investing/2017/04/19/why-ultragenyx-pharmaceutical-stock-is djmurdock 04/20/17 09:42:27 PM
#1194   If memory serves me, it was over a djmurdock 04/20/17 11:21:35 AM
#1193   anyone know how/what they have done to address u508 04/20/17 09:00:51 AM
#1192   Piper Jaffray analyst, Charles Duncan, reiterated his Overweight king oil 04/19/17 09:14:03 PM
#1191   Yep, in one of the recent presentations they JohnBlaze 04/19/17 08:31:35 PM
#1190   I agree. So far the results have been djmurdock 04/19/17 08:23:47 PM
#1189   They will be good. Nothing on the market JohnBlaze 04/19/17 10:44:12 AM
#1188   what happens if the next result is not smallbio 04/19/17 10:41:21 AM
#1187   $23 by June for sure. Especially after they JohnBlaze 04/19/17 10:37:44 AM
#1186   Agreed. Seeing (hoping) $23 by june seppi08162 04/18/17 05:58:13 PM
#1185   Got some more today. I really like this CoachMarc 04/18/17 05:02:56 PM
#1184   Anything can happen in the world...we can't control a surfer 04/16/17 04:20:15 PM
#1183   CARA bullish 17.53 stocktrademan 04/16/17 03:50:18 PM
#1182   True, but I do not see CARA falling CoachMarc 04/14/17 10:06:26 AM
#1181   It'll be a while before more results are reef_heart 04/13/17 09:52:28 PM
#1180   17's is a great loading zone with all a surfer 04/13/17 11:16:48 AM
#1179   yeah looking good. he's a key speaker too Android 2-73 04/11/17 02:41:36 PM
#1178   A new path to pain relief. Time for TERIA 04/11/17 11:06:38 AM
#1177   Why Cara Theraputics Will Soar king oil 04/07/17 06:50:10 PM
#1176   short play the odds as mosts bios Android 2-73 04/06/17 01:08:20 PM
#1175   :-D $CARA Cbdpotential 04/06/17 12:18:55 PM
#1174   I'm really surprised if the short interest is king oil 04/06/17 12:02:40 PM
#1173   New stock owner. Like the science and Bases Loaded 04/06/17 11:57:34 AM
#1172   managements and insider confidence such RHO CAPITAL PARTNERS Android 2-73 04/06/17 11:00:08 AM
#1171   lets hope for good post op phase 3 Android 2-73 04/06/17 10:58:29 AM
#1170   $92M cash from offering! > FDA phase III crudeoil24 04/06/17 10:01:00 AM
#1169   Bought a few shares here. PT of $33.00 crudeoil24 04/06/17 09:27:25 AM
#1168   100 % agree . I'm holding a core simmons420 04/05/17 11:45:31 PM
#1167   I've seen many go south after interviews but a surfer 04/05/17 11:11:53 PM
#1166   That was really fast and generated a huge king oil 04/05/17 09:33:19 PM
#1165   Cara Therapeutics Announces Closing of Its Public Offering a surfer 04/05/17 09:04:43 PM
#1164   Stellar interview. Really impressive. IMHO $18 is the djmurdock 04/05/17 06:47:53 PM
#1163   The interview on Cramer was on point!! a surfer 04/05/17 06:41:22 PM
#1162   I have a gut feeling (and obviously DD) djmurdock 04/05/17 06:19:07 PM
#1161   Offering done or about done according the recent zippoenergy 04/05/17 12:01:04 PM
#1160   Looking good $CARA Cbdpotential 04/05/17 10:34:14 AM
#1159   Thanks for the heads up! a surfer 04/05/17 10:20:41 AM
#1158   CEO is on Mad Money tonight with Jim JKM1 04/05/17 10:19:30 AM
#1157   Added 1100 shares this morning under 17.30! a surfer 04/05/17 09:57:59 AM
#1156   You would be adding at a very good CoachMarc 04/04/17 02:06:24 PM
#1155   I agree I'm adding $CARA simmons420 04/04/17 01:49:50 AM
#1154   Wow! This is epic. Glad i'm still holding djmurdock 04/04/17 01:12:09 AM
#1153   odds of successful pain trial? Android 2-73 04/03/17 11:40:01 PM
#1152   http://ih.advfn.com/p.php?pid=nmona&article=74246562&symbol=CARA 500,000 at $18. a surfer 04/03/17 09:57:41 AM
#1151   I totally agree...$80 Million should also be more djmurdock 04/01/17 08:36:02 PM
#1150   We will see $30 by the summer pennystockaholic 04/01/17 05:57:00 PM
#1149   Looks like the offer price is $18, not king oil 04/01/17 01:08:23 PM
#1148   I think the sold volume is about right seppi08162 03/31/17 12:01:23 PM
PostSubject