Gabapentin

Strong Interest in Trial Participation Resulted in Enrollment Exceeding Target by 20 Percent and Completion Ahead of Schedule Top-line Data Expected in Q1 2025 Nov. 26, 2024 -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the completion of patient enrollment in the PROGRESS (A Phase 2b, Dose-ranging, Randomized, Double-blind, PlacebO-controlled, Parallel-GRoup, MulticEnter Study with an Open-label Extension in PatientS with Diabetic Peripheral Neuropathic Pain) study evaluating LX9211, a novel, orally-delivered, selective investigational small molecule inhibitor of adaptor-associated kinase 1 (AAK1), for the treatment of diabetic peripheral neuropathic pain (DPNP). The study successfully enrolled 494 patients, approximately 20 percent more than originally targeted, marking a significant milestone in the trial and increasing study power. Top-line data from PROGRESS is expected to be announced in Q1 2025. "We are pleased to have completed enrollment for the PROGRESS study of LX9211 in DPNP, a condition for which there is significant need for new, non-opioid treatment options," said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. "The strong interest in this study resulted in enrollment significantly exceeding the target and completion of enrollment eight weeks ahead of schedule, underscoring the urgent demand in DPNP. We are confident that the greater-than-expected enrolled patient population will lead to critical insights, inform our Phase 3 design and add to the body of evidence supporting the use of LX911 in treating neuropathic pain and we look forward to sharing top-line findings from the study early next year." PROGRESS commenced in December of 2023 with the goal of enrolling adult patients with a diagnosis of diabetes (type 1 or type 2) with moderate to severe DPNP. The study is placebo-controlled with a primary endpoint of reduction of Average Daily Pain Score (ADPS) at 8 weeks. Secondary endpoints include change from baseline in burning pain and pain interference with sleep. Study design permitted patients to maintain one stable-dose DPNP therapy (gabapentin, pregabalin or duloxetine) without being forced to withdraw from therapies that, although inadequate, may be providing benefit – aligning with how new DPNP drugs are likely to be used in practice. DPNP is a type of nerve damage caused by chronically high blood sugar and is a major disabling and devastating consequence of long-term diabetes. It can result in pain, numbness, and other symptoms in the hands, feet, legs, and arms. There are approximately 20 million patients in the U.S. who are suffering with some type of neuropathic pain, of which about 5 million have DPNP. Discovered using Lexicon’s unique approach to gene science, LX9211 is a potent, orally delivered, selective, investigational small molecule inhibitor of AAK1. Lexicon identified AAK1 in its target discovery efforts as a promising approach for the treatment of neuropathic pain. Preclinical studies of LX9211 demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain without affecting opiate pathways. LX9211 received Fast Track designation from the U.S. Food and Drug Administration for development in DPNP. Lexicon 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 treat disease safely and effectively. Lexicon has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity, metabolism and other indications. For additional information, please visit www.lexpharma.com. The content above comes from the network. if any infringement, please contact us to modify.

Pharmacodynamic Results from the CAN-001 Phase 1b Study of PP-01, an Investigational Product, intended to Mitigate Cannabis Withdrawal Syndrome PHOENIXVILLE, Pa., Nov. 18, 2024 /PRNewswire/ -- PleoPharma, Inc., a privately held company focused on cannabis-related health issues, announced today, the presentation of data from their Phase 1b Pharmacokinetic and Pharmacodynamic study of Cannabis Withdrawal Syndrome ("CWS") in participants with Cannabis Use Disorder ("CUD") at the annual meeting of the American Academy of Addiction Psychiatry (AAAP) in Naples, Fla. "We are pleased to present our proof-of-concept study that evaluated the safety and effectiveness of PP-01, a novel, dual-mechanism investigational agent containing tapering and titrating doses of nabilone and gabapentin in mitigating cannabis withdrawal symptoms in participants with moderate to severe CUD. We are excited to be developing PP-01 with the goal of being the first FDA approved product to help people suffering from CWS, a rapidly growing patient population in need of treatment. We are currently preparing for PP-01 to enter Phase 3", stated Shelli Graham, PhD, Senior Vice-President of Medical/Clinical Research. Participants in the CAN-001 Study reported using an average of 3.5 ± 2.2 grams/day of cannabis with a mean age of first use 14 years (range 6 to 22). By DSM-5 criteria, 64% had severe CUD and 36% had moderate CUD. Compared to placebo, PP-01 administered once daily significantly reduced mean CWS ratings beginning 4 hours post first dose of PP-01 (first measured timepoint). This effect was sustained through Day 5 (P values < 0.0009; all timepoints). Participants experienced fewer cravings, better sleep and were also less bothered by their withdrawal symptoms when treated with PP-01 than with placebo (P values < 0.007; all timepoints). PP-01 was well tolerated. There were no serious adverse events, and all adverse events in the PP-01 group were mild in severity. About cannabis withdrawal/cannabis use disorder The US Government reported that in 2023 (samhsa.gov), ~19.2 million Americans had CUD with 1.64 million people receiving treatment (~500k inpatient, ~1.1 million outpatient). The number of individuals who received treatment for cannabis related health problems has grown by an average of 28% annually from 2018 to 2023. People with CUD commonly experience significant withdrawal symptoms, known as CWS, that can make it extremely difficult to reduce or discontinue cannabis. There are currently no FDA approved medications for the treatment of CWS or CUD. About PleoPharma, Inc. PleoPharma, Inc. is a clinical stage development company in the neuropsych and addiction space with a lead asset, PP-01, that is being developed as the first FDA approved treatment of CWS in people with CUD. The PleoPharma team includes a world class management team and board of directors who have produced multiple high value exits, >50 worldwide product approvals, and 100+ INDs. For more information on PleoPharma, please visit or email Dawn Halkuff, head of Investor Relations at [email protected]. This release includes 'forward-looking statements' regarding the operations of PleoPharma, Inc., actual results may differ from its expectations, estimates, and projections and, consequently, you should not rely on these forward-looking statements as predictions of future events. All statements other than statements of historical facts contained herein are forward-looking statements that reflect the current beliefs and expectations of management of PleoPharma. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. PleoPharma does not undertake or accept any obligation or undertaking to release any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. SOURCE PleoPharma, Inc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED