Physician Views: How have recent data, study design events shaped doctors thinking on lead NASH agents

Physician Views: How have recent data, study design events shaped doctors thinking on lead NASH agents

Code: FW-20150602 | Published: Jun-2015 | Pages: - | FirstWord
Price :

* Required Fields



Biotech is a notoriously volatile sector, and pure-play nonalcoholic steatohepatitis (NASH) drug developers have for the past couple years occupied one of the more volatile neighbourhoods within it thanks to growing appreciation for the how big the multi-billion dollar market could be and, in turn, more interest from investors attempting to predict how the race to the regulatory finish line - and the subsequent battle for scripts - will play out.

Genfit and Intercept, which along with Gilead are two of the three most advanced companies in the space, recently made important announcements regarding their respective NASH development programmes.

The more binary of the two events was a Phase II readout from Genfit, which put on a brave face while reporting in late March that its GFT505 missed the studys primary endpoint by failing to achieve a significant impact on fibrosis after one year. The company said the inclusion of less severe NASH patients confounded the results, thus masking the true effect of the compound, and that it would plough ahead into Phase III testing based on the findings. (See ViewPoints: Genfit ploughs on with GFT505, but Phase II data far from GOLDEN.)

With Gilead still in the midst of Phase II testing, Genfits stumble left Intercept as the undisputed leader in the race to market based on the success of its obeticholic acid (OCA), which was the first programme to draw the attention of generalist investors when in January 2014 it produced unexpectedly strong results in the Phase II FLINT study. The companys shares tripled on the day of the announcement.

In the months since, Intercept has gone on to provide a number of updates on the study, some good (eg, achieving a significant impact on fibrosis) and others not so good (eg, concern about its cardiovascular safety profile based on elevations of cholesterol levels), many of which have resulted in massive swings in the companys market cap.

The most recent update came last month when Intercept announced it had received approval from the FDA and EMA on the design of the Phase III REGENERATE trial that will get underway next quarter and is intended to support registration of OCA inside and outside the US. Analysts seemed to like the study but investors appeared to be taken off guard, both by its size (2500 patients) and the robustness of the co-primary endpoints, which included liver fibrosis improvement with no worsening of NASH and NASH resolution with no worsening of liver fibrosis. Indeed, Intercept shares have slumped more than 20 percent since the detailed plans were disclosed. (See Spotlight On: Full steam ahead - regulators onside as late-stage studies for key pipeline drugs are approved, but Intercept investors not convinced.)

How damaging was GFT505s Phase II readout? Are doctors concerned about OCAs efficacy or safety profile? To gain better understanding about how the recent announcements from Intercept and Genfit are into physicians evolving views on the various NASH agents, FirstWord PLUS is polling US- and/or EU5-based gastroenterologists and asking them

- How confident are you that OCA will meet its co-primary endpoints?
- Intercept has suggested a cardiovascular outcomes trial (CVOT) will not be required prior to approval. Assuming efficacy endpoints are reached (and cholesterol increases are on par with Phase II data) how concerned will you be about the safety profile of OCA in the absence of CVOT data?
- How concerned would you be about using concomitant statin therapy to manage OCAs impact on LDL cholesterol?
- OCA could be launched to treat primary biliary cirrhosis as soon as early 2016. Assuming this happens and no untoward surprises are observed in other studies, how often might you consider prescribing the product to NASH patients (in the intervening years prior to when OCA is potentially approved for NASH in the 2019 timeframe)?
- Genfits GFT505 recently failed to hit its primary endpoint in a Phase IIb study, which was blamed on the inclusion of less severe NASH patients. Based on your experience with less severe NASH patients, would you agree that this could logically have confounded an otherwise good result?

Report Format

Following are different modes of Licenses.

a. Single User License:
This license allows only one person to use the report. This person can use the report on any computer and may take print outs of the report but must take care of not sharing the report (or any information contained therein) with any other individual or people. Unless you purchase a Site License or a Global Site License, a Single User License must be purchased for every single person that wishes to use the report within the same enterprise.

b. Single Site License:
This license allows unlimited users to use the report within one company location, e.g. a regional office. These users can use the report on any computer and may take print outs of the report but must take care of not sharing the report (or any information contained therein) with any other individual or people.

c. Global Site License:
A Global Site License (or Enterprise wide Site License or Global License) is a license granted to original purchaser, who can share a report with other employees and authorized Users of the same organization.

Quick Help

1. How do you deliver the reports?
The delivery of reports is depends on format & mode of license of report(s). Following are different kinds of formats of report(s) and their delivery options :

a. Electronic Format – Through email from Publisher
Report will be sent to your username email address in PDF, Excel, PowerPoint or any other electronic / softcopy format by publisher.
Delivery Time: 12 to 48 hours [depending on time difference or occurrences of national holidays]

b. Hard Copy or Printed Format or CD-Rom – Through Mail or Courier from Publisher
Report will be sent through mail / courier delivery to your shipping address by publisher.
Delivery Time: Less than, few weeks [depending on time difference or occurrences of national holidays]

2. How can I make payment for publications I purchase?
You could be able to make the payment, in following ways:

a. Online Secure Payment through Credit Card Payment : We accept Visa, Master, AMEX Cards & CCAvenue
b. Transfer of fund to our bank account via Bank transfer or Wire transfer
c. Payment via DD or Cheque
d. Paypal

3. Is it safe to use my credit card on MarketinfoResearch?
Your personal information and online tranaction on Marketinfo Research is secure, private, and tamper-proof. All credit card payments are processed through secure and trusted payment gateways.

If you have a more question about our publications please see our FAQs section or contact us now at cs@marketinforesearch.com.


There are no reports matching the selection.

Browse similar reports by category:
Pharmaceuticals & Healthcare

Our Clients