Lexicon Pharmaceuticals (LXRX) will partner with JDRF (Juvenile Diabetes Research Foundation) for a phase 2 study of LX4211 in younger Type 1 Diabetes (T1D) patients (<30 years old), the company announced on July 9th. The research foundation will provide funding for the 76-patient, 12-week phase 2 study, though the dollar amount or cost-split was not made public in Wednesday’s press release.
Recall that Lexicon has been seeking a partner to fund phase 3 studies of LX4211 in Type 2 Diabetes for years, to no avail, and the partnership headline on July 9th caused some initial excitement. Lexicon has said repeatedly that they will not move into phase 3 without a partner, critical because of the expected size and expense of this program – finding non-dilutive funding is at the top of investors’ priorities.
Lexicon successfully completed a phase 1 study of LX4211 in T1D this April that included a 33-patient double-blind, placebo-controlled expansion phase. Pending an end-of-phase 2 meeting with the FDA, Lexicon indicated at the time that a phase 3 program in T1D could begin by the end of this year. The FDA meeting was expected to take place during the second quarter.
What’s not clear in the JDRF press release on Wednesday is whether Lexicon has met with the FDA yet, or whether FDA requested this new phase 2 study before Lexicon moves into phase 3, our initial concern. Lexicon Investor Relations confirmed on Wednesday that this study was not planned at FDA request following the end-of-phase 2 meeting, and that previous commentary on a T1D phase 3 study by year-end has not changed.
Though the company expects to play a greater role in any phase 3 T1D program, Lexicon is essentially now pre-phase 3 with two tremendously expensive programs and no deep-pocketed partner for phase 3. The company ended the first quarter with $98.4 million in cash and investments and burned $30 million in the first quarter.
Also this week, LXRX announced the hiring of former Easai executive, Lonnel Coats, as CEO and president.
