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New treatments in development

Drug Development

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#1 Robert_Larsson

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Posted 19 May 2019 - 04:13 PM

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Last updated 8th of June 2020

This is a comprehensive list of drugs currently in development to treat Irritable Bowel Syndrome. The format is made to be simple and self explanatory. In case this is not so I have provided some definitions below to guide unsure readers through each column. 

 

Click here for the Image file of the list below, in case the formatting does not fit your screen.

 

Name/dev. Code----------Company--------------------------Mechanism of Action------------------------------------IBS sub-type---------------------------Status-------------------------Ongoing Trial------------------------Participate

Olorinab----------------Arena Pharmaceuticals--------------CB2 agonist---------------------------------------------------IBS-Pain------------------------------Phase 2B ongoing---------------NCT04043455------------------------Captivate

ORP-101---------------OrphoMed------------------------------mu-opioid agonist/ kappa-opioid antagonist------------IBS-D---------------------------------Phase 2 ongoing-----------------NCT04129619------------------------Prevail

BOS-589---------------Boston Pharmaceuticals-------------RET kinase inhibitor-----------------------------------------IBS-D---------------------------------Phase 2A ongoing---------------NCT03977155------------------------Study Completed

Vibegron --------------Urovant Sciences----------------------Beta 3 adrenergic agonist---------------------------------IBS-Pain in Women-----------------Phase 2 ongoing-----------------NCT03806127------------------------Recruitment open

Solabegron------------Velicept Therapeutics----------------Beta 3 adrenergic agonist----------------------------------IBS-Pain------------------------------Phase 1

Tenapanor-------------Ardelyx----------------------------------NHE3 Inhibitor-------------------------------------------------IBS-C---------------------------------Approved as IBSRELA

SYN-010---------------Synthetic Biologics--------------------HMG-CoA reductase inhibitors----------------------------IBS-C----------------------------------Phase 2 ongoing-----------------NCT03763175------------------------Recruitment ended

Naronapride-----------Renexxion------------------------------5-HT4 agonist-------------------------------------------------IBS-C----------------------------------Phase 2

Bekinda----------------Redhill Biopharma--------------------5-HT3 antagonist---------------------------------------------IBS-D----------------------------------Phase 2

Aemcolo----------------Cosmo Pharmaceuticals------------DNA-directed RNA polymerase inhibitors----------------IBS-D----------------------------------Phase 2----------------------------NCT03099785------------------------Recruitment open

SCN-001---------------SciCann Therapeutics---------------TRPV1/CB2---------------------------------------------------To be announced--------------------Phase 1/2

GSK-3179106---------GlaxoSmithKline----------------------RET kinase inhibitor-----------------------------------------IBS-D----------------------------------Phase 1

MET-409---------------Metacrine-------------------------------Farnesoid X-activated receptor agonists----------------IBS-D----------------------------------Phase 1

Blautix------------------4D Pharma PLC-----------------------Blautia Hydrogenotrophica---------------------------------IBS-------------------------------------Phase 2----------------------------NCT03721107------------------------Recruitment ended

RQ-00310941--------RaQualia--------------------------------5-HT2B antagonist-------------------------------------------IBS-D---------------------------------Phase 1

ASP7147--------------Sedar Pharma--------------------------Bombesin-2 receptor antagonist--------------------------IBS-D---------------------------------Phase 1

Crofelemer------------Napo Pharmaceuticals----------------Chloride channel antagonists-----------------------------IBS-D----------------------------------Phase 2

CSTI-300--------------Consynance Theraputics------------5-HT3 antagonist---------------------------------------------IBS-D----------------------------------Phase 1 ongoing----------------NCT04296799

PP-101----------------Prismic Pharmaceuticals--------------Palmitoylethanolamide--------------------------------------IBS-------------------------------------Phase 1 ongoing----------------ACTRN12620000213943p

VBX-100---------------Vitality Biopharma---------------------Dronabinol prodrug-----------------------------------------To be announced--------------------Awaiting IND

CIN-103---------------CinRX Pharma--------------------------undisclosed----------------------------------------------------IBS-D----------------------------------Pre-clinical

NBTX-001-------------Nobilis Therapeutics-------------------Xenon Gas----------------------------------------------------IBS-------------------------------------Pre-clinical

OCT461201---------Oxford Cannabinoid Tech-------------CB2 agonist----------------------------------------------IBS-Pain----------------------------Pre-clinical

 

 

Table explanation

  • Name/ dev.Code; the name given to an Investigational New Drug by the drug company
  • Company; the Company driving the drugs though its clinical stages of development
  • Mechanism of Action; refers to the specific biochemical interaction through which a drug substance produces its pharmacological effect
  • IBS subtype; which IBS type (Constipation/Diarrhea/Mixed/PI/Undefined) or specific symptom for ex. pain, motility etc. is being targeted by the referenced drug
  • Status; how far a drug has progressed in its development, 'Phase' refers specifically to which Clinical Phase the drug has entered (there are 3 phases in the typical timeline)
  • Ongoing Trial; provides official information on the government run Clinical Trials database about ongoing or past studies
  • Participate; if you would like to participate in the Clinical Trial you can follow the provided link for more information on how to apply.

 

Drugs in ongoing trials

 

Olorinab (APD371), is a painkiller for all IBS sub-types (78% of patients suffer from abdominal pain). It is currently under development by Arena Pharmaceuticals and has now entered into another Phase 2 Clinical Trial (NCT04043455). Olorinab lessens pain by targeting the Cannabinoid Type 2 Receptor (CB2). The compound is peripherally acting and highly selective which means it lacks psychotropic effect (it doesn't make you high), which is quite important when targeting the Cannabinoid system. Last year Arena published results of an exploratory Phase 2a safety and efficacy trial, which showed a good safety profile and an average pain reduction of 82% in patients with Crohn's Disease in remission, suffering the same type of pain IBS patients do.

 

To participate in the Phase 2 study, click here to get further information from Arena or give them a call if you're in the US at 855-634-0290. Participants can receive up to $1,335 for participating in this study.

 

ORP-101, currently being developed for IBS-D works by slowing down intestinal transit while simultaneously easing abdominal pain. The compound is developed by Orphomed and is currently entering Phase 2 Clinical Trials (NCT04129619). It is a gut-restricted and non-systemic partial agonist of the μ-opioid receptor and full antagonist of the κ-opioid receptor. This limits side effects substantially and makes it non addictive, which is very important given the situation in the U.S. ORP-101 has shown good pre-clinical and clinical Phase 1 results and received a Fast Track designation by the FDA in 2018.

 

To participate in the Phase 2 study sign up here at their Prevail study site which provides additional information to patients.

 

BOS-589, under development for IBS-D is designed to mitigate visceral hypersensitivity and target both abdominal pain and motility. It works by inhibiting RET (REarranged during Transfection) kinase, found to be compromised in patients with Hirschsprung's disease (which usually suffer constipation and obstruction). RET kinase is important for the normal functioning of the enteric nervous system. There have been several studies showing its promising effect as a target for IBS-D patients. BOS-589 is under development by Boston Pharmaceuticals and is currently finishing up Phase 2 clinical trials (NCT03977155).Top-line results are expected in the first half of 2020.

 

Vibegron, currently in Phase 2 trials (NCT03806127) for Women with IBS-Pain, already marketed in Japan and awaiting marketing approval in the USA after successful trials in patients suffering from Overactive Bladder. This is a medication with several applications of which one is IBS related pain, so far only for women. A similar compound that has not gone as far in its development is Solabegron. Both are Beta 3 adrenergic receptor agonists and are supposed to target pain and urgency, something shared by its other indications. Vibegron is developed by Urovant Sciences.

 

SYN-010 is a reformulation of the already approved drug Lovastatin, which is intended to reduce methane-production by certain microorganisms (M. smithii) to combat bloating, pain and constipation in patients with IBS-C. By using a delayed release formula it's designed to act primarily in the intestinal lumen while avoiding systemic absorption and thus enhancing its efficacy. SYN-010 is being developed by Synthetic Biologics and is currently finishing up Phase 2 clinical trials (NCT03763175). Top-line results are expected in the first half of 2020, potential 505(B)2 filings and expedited development might be available pending a meeting with the FDA. 

 

Blautix is a single-strain human gut commensal bacteria which is being investigated for the treatment of IBS. By its distinct metabolism Blautix consumes gases which are known to cause bloating, abdominal pain and changes in bowel frequency. 4D Pharma is currently conducting a Phase 2 clinical trial (NCT03721107) to see if Blautix is effective in both IBS-C and IBS-D patients. Enrollment into the Phase 2 study has closed and we are currently awaiting results.

 

 

Inclusion Criteria

To qualify for this list of drugs under development I have chosen to only include compounds which are using the FDA designated development path of either 505B(1) or 505B(2) or corresponding filings by other Agencies in Europe, Japan, Australia & New Zealand, Switzerland, Canada or other. Supplements, Medical Foods, Probiotics not seeking a 505(B)1 application and Medical devices will be mentioned in other posts as they require different criteria for approval by federal agencies.

 

Last updated 8th of June 2020

 

Disclaimer\ This content uses public information in order to inform patients about ongoing drug development. It is not meant to advertise or promote statements made by individual drug developers.*


  • annie7 and abby_smile like this

#2 annie7

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Posted 20 May 2019 - 05:56 AM

thanks for posting this. very informative.


  • Robert_Larsson likes this

these are just my own thoughts. for expert medical advice please contact a health care professional.


#3 Godiva

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Posted 20 May 2019 - 07:03 AM

like it


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#4 nsmythe88

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Posted 22 May 2019 - 12:09 PM

No offence. I'm always a little suspicious about someone's first posting with information like this and the motives behind it.

I found this online which might be a little more accurate? dependable? without bias? for new treatments in development, https://bit5Chg



#5 Robert_Larsson

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Posted 15 June 2019 - 08:07 AM

The approach taken above is that one does not have to rely on the information blindly, rather all the information is publicly available and so personal inquiry can confirm the information independently. The motive to provide this information is to inform patients of the landscape of some of the Clinical developments, something which is not easily available if patients do not know where to look in the first place. As for the information you have provided, I think you should take a similar approach, find the information, inquire and verify where possible. A skeptical approach should be guiding in this environment. Best of luck to you and take care!







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