US-based biopharmaceutical company Lycera has started the Ulcerative Colitis Phase 2 Study to Assess Remission by Treatment (UPSTART) clinical trial of LYC-30937-Enteric Coated to treat ulcerative colitis (UC).

LYC-30937 is developed as an orally administered, gut-directed ATPase modulator to specifically target and induce cell death (apoptosis) in disease-causing immune cells (T-lymphocytes), while leaving normal cells unaffected.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The randomised, double-blind, placebo-controlled parallel group Phase II trial is expected to include 120 patients who will be randomised on a 1:1 basis, to be administered with either LYC-30937-EC or placebo.

The patients will be treated for a period of eight weeks with an additional two-week safety follow-up.

"Despite progress in treatment options for patients with UC, we believe there is still significant need, one where LYC-30937-EC may play an important future role."

The trial has been designed to evaluate the safety and efficacy of LYC-30937-EC when administered orally on a once-daily basis to patients affected by ulcerative colitis.

See Also:

It is primarily focused on achieving a clinical remission of disease of the patients after eight weeks, determined by the basis of modified Mayo score (MMS).

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

It will also evaluate the safety in the administration of LYC-30937-EC.

Lycera president and CEO Paul Sekhri said: "The initiation of the Phase II clinical trial of LYC-30937-EC is an important milestone in Lycera's continued progress, and is one of several clinical studies we plan to initiate in the second half of 2016 as we build our portfolio of novel immune modulatory treatments.

"Based upon the results of our preclinical and Phase I studies, we believe LYC-30937-EC may possess key advantages for patients, including localised therapy at the site of disease, and the potential for reduced systemic exposure and side effects.

“Our candidate also offers the convenience of once-daily oral dosing. Despite progress in treatment options for patients with UC, we believe there is still significant need, one where LYC-30937-EC may play an important future role."

Preclinical studies have suggested the efficacy of LYC-30937 in treating ulcerative colitis, as well as in other autoimmune diseases.