Lexicon Pharmaceuticals to Announce Topline Results from Phase 2b PROGRESS Study Evaluating Pilavapadin (LX9211) in Adults with Diabetic Peripheral Neuropathic Pain
03 March 2025 - 8:13AM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the
Company will hold a conference call and webcast on Monday, March 3,
2025 at 8:00 a.m. ET to share topline results from the Phase 2b
PROGRESS (A
Phase 2b, Dose-ranging,
Randomized, Double-blind,
Placeb
O-controlled,
Parallel-
GRoup, Multic
Enter
Study with an Open-label Extension in
Patient
S with Diabetic Peripheral Neuropathic
Pain) study evaluating pilavapadin (LX9211), an oral, non-opioid
investigational adaptor-associated kinase 1 (AAK1) inhibitor in
adult patients with moderate to severe diabetic peripheral
neuropathic pain (DPNP).
Conference Call and Webcast InformationLexicon
management will hold a live conference call and webcast on Monday,
March 3, 2025, at 8:00 a.m. ET / 7:00 a.m. CT to review the details
of this announcement. Participants can access the conference call
live via webcast on the Events page of the Company’s website at
https://investors.lexpharma.com/. Participants who wish to ask a
question may register here to receive dial-in numbers and
a unique pin to join the call. An archived version of the webcast
will be available on the Lexicon website.
About the PROGRESS StudyThe PROGRESS study
commenced in December 2023 and enrolled 496 adult patients with a
diagnosis of diabetes (type 1 or type 2) and moderate to severe
DPNP. The study was placebo-controlled with a primary endpoint of
change from baseline to Week 8 in ADPS as compared to placebo and
evaluated three treatment groups receiving once daily pilavapadin
doses of 10 mg, 20 mg or 20 mg for seven days followed by 10 mg
thereafter. Secondary endpoints included change from baseline to
Week 8 in burning pain and pain interference on sleep. Study design
permitted patients to remain on one stable-dose DPNP therapy (e.g.
gabapentin, pregabalin or duloxetine) without withdrawing from
therapies that, although inadequate, may be providing some benefit
– aligning with how new DPNP drugs are likely to be used in
practice.
About Diabetic Peripheral Neuropathic Pain
(DPNP)DPNP is a debilitating chronic complication of
diabetes which can result in burning pain, numbness, and other
symptoms in the hands, feet, legs and arms. There are approximately
9 million patients in the U.S. who are suffering with DPNP.
About PilavapadinDiscovered using Lexicon’s
unique approach to gene science, pilavapadin (LX9211) is a potent,
once-daily, orally delivered, selective, investigational small
molecule inhibitor of AAK1, a novel target for neuropathic pain
which inhibits reuptake and recycling of neurotransmitters involved
in pain signaling without affecting opiate pathways. Lexicon
identified AAK1 in its target discovery efforts as a promising
approach for the treatment of neuropathic pain. Preclinical studies
of pilavapadin demonstrated central nervous system penetration and
reduction in pain behavior in models of neuropathic pain without
affecting opiate pathways.
About Lexicon PharmaceuticalsLexicon is a
biopharmaceutical company with a mission of pioneering medicines
that transform patients’ lives. Through the Genome5000™ program,
Lexicon’s unique genomics target discovery platform, Lexicon
scientists studied the role and function of nearly 5,000 genes and
identified more than 100 protein targets with significant
therapeutic potential in a range of diseases. Through the precise
targeting of these proteins, Lexicon is pioneering the discovery
and development of innovative medicines to safely and effectively
treat disease. Lexicon has advanced multiple medicines to market
and has a pipeline of promising drug candidates in discovery and
clinical and preclinical development in heart failure, neuropathic
pain, obesity, cardiology, diabetes and other indications. For
additional information, please visit www.lexpharma.com.
For Investor and Media
Inquiries:Lisa DeFrancesco Lexicon Pharmaceuticals,
Inc.lexinvest@lexpharma.com
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