An Update on Pivotal Phase 3 Study - Report on Lexicon Pharmaceuticals

Aug 11, 2015, 09:20 ET from www.aciassociation.com

NEW YORK, August 11, 2015 /PRNewswire/ --

ACI Association has initiated research coverage on Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX). Select highlights from the internally released reports are being made available to the general public (included below), with access to the entirety of the research available to new members.

Today, membership is open to readers on a complementary basis at the following URL: http://www.aciassociation.com/?c=LXRX  

Highlights from our LXRX Report include:

  • Update on the TELESTAR Phase 3 Clinical Trial - On August 3, 2015, Lexicon Pharmaceuticals, Inc. announced that the pivotal TELESTAR Phase 3 clinical trial met its primary endpoint. The trial showcased the benefit of the oral dose of the investigational drug, telotristat etiprate, in treating cancer patients with carcinoid syndrome.
  • About Telotristat Etiprate - Telotristat etiprate, discovered by the Company using its unique approach to gene science, if approved, would be the first oral treatment successfully developed for carcinoid syndrome. Also, it would be the first addition to the standard of care in over 16 years.
  • Concept behind the TELESTAR Phase 3 Trial - For this double-blind Phase 3 study known as TELESTAR, Lexicon Pharmaceuticals enrolled a total of 135 patients with carcinoid syndrome which was not adequately controlled on the current standard of care, the SSA therapy.
  • The Top-Line Results - Citing positive outcome of the study, Lexicon Pharmaceuticals' release added that top-line results from the Phase 3 study showed that the patients who added telotristat etiprate to the standard of care at both the 250 mg and 500 mg doses experienced a statistically significant reduction from baseline compared to placebo in the average number of daily bowel movements over the 12-week study period (p<0.001), meeting the study's primary endpoint.
  • A Key Secondary Measure from the Study - While meeting the primary endpoint, the study also demonstrated a secondary measure wherein a notably higher number of patients on telotristat etiprate dose achieved at least a 30% reduction in daily bowel movements over at least half the days of the study period, as compared to 20% response on placebo (p<0.040). In other words, the patients achieved a durable response of 44% and 42% in the 250 mg and 500 mg arms, respectively.
  • Incidences of Adverse Events - It was observed that the proportion of patients with treatment-emergent adverse events (AEs), serious AEs and discontinuation due to AEs were generally similar in all three treatment arms. In the study, the overall incidences of AEs were consistent with those reported in previous studies.

To find out how this influences our rating on Lexicon Pharmaceuticals, Inc., read the full report in its entirety here: http://www.aciassociation.com/?c=LXRX

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