Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) signed a collaboration accord with AC Bioscience Ltd for its S1P (small molecule sphingosine-1-phosphate) lyase inhibitor – LX2931. As per the deal, the company will provide access to its clinical and pre-clinical data of LX2931. AC Bioscience will not receive any license or grant under the patent rights for this compound.
The rapid development of the LX2911 program
EVP (R&D) of Lexicon, Praveen Tyle said the company will continue to evaluate its pipeline and find the most effective way for advancing a broad library of the compounds/ targets. It is part of its strategy to expedite the LX2911 development program.
AC Bioscience to pay an upfront payment
As per the terms of the collaboration agreement, AC Bioscience will pay an upfront payment of $5.3 million to Lexicon. It is also eligible to receive additional payments on achieving certain milestones.
Receives FDA regulatory feedback
Lexicon received regulatory feedback from the US FDA. According to this communicative, the results obtained from its phase 3 clinical studies of SCORED and SOLOIST indicates support for NDA submission for lowering cardiovascular death risk. It also mitigates the urgent hospital visits for adults suffering from heart failure because of the risk posed by type 2 diabetes.
Lexicon received feedback from the US FDA following its request after completing the trials of SCORED and SOLOIST. The feedback from the regulator allows the company to enter discussions with partners for sotagliflozin in HF (heart failure) and submit NDA this year.
SOLOIST is a double-blinded, randomized, multicenter, and placebo-controlled phase 3 clinical trial evaluating the efficacy of sotagliflozin in treating cardiovascular risks. The study is conducted in 1,200 patients suffering from type 2 diabetes, who are recently admitted to the hospitals for heart failure, against placebo. Its primary target is to measure the number of deaths that occurred because of cardiovascular diseases, urgent visits of patients treated with sotagliflozin Vs placebo to the hospitals, and hospitalizations because of heart failure.
SCORED is a placebo-controlled, double-blinded, randomized, and multicenter phase 3 clinical trial to evaluate the efficiency of sotagliflozin against placebo. The study is conducted on 10,584 patients suffering from chronic kidney disease, type 2 diabetes, and cardiovascular disease risks. Its primary endpoint is to find the number of deaths caused due to heart failure-related hospitalizations, cardiovascular causes, and urgent hospital visits of the patients, who are treated with sotagliflozin against placebo.
According to the findings, SCORED and SOLOIST achieved their primary endpoints.