AAK1

Lexicon Pharmaceuticals Reports Fourth Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, March 11, 2024

ET

Key Points: 
  • ET
    THE WOODLANDS, Texas, March 11, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months ended December 31, 2023 and provided an update on key corporate milestones.
  • “2023 was a pivotal year for Lexicon,” said Lonnel Coats, Lexicon’s chief executive officer.
  • Unless otherwise stated, all comparisons are for the fourth quarter and full year of 2023 compared to the fourth quarter and full year of 2022.
  • Revenues: Revenues for the fourth quarter and full year of 2023 were $0.7 million and $1.2 million, respectively, primarily from the commercialization of INPEFA.

Satellos Announces Promising Preliminary Data in Facioscapulohumeral Muscular Dystrophy

Retrieved on: 
Tuesday, February 13, 2024

Satellos Bioscience Inc. (“Satellos” or the “Company”) (TSXV: MSCL) (OTCQB: MSCLF), a public biotech company developing new small molecule therapeutic approaches to improve the treatment of muscle diseases and disorders, announced today positive preliminary data showing SAT-3247 can improve skeletal muscle function in a mouse model of facioscapulohumeral muscular dystrophy (FSHD).

Key Points: 
  • Satellos Bioscience Inc. (“Satellos” or the “Company”) (TSXV: MSCL) (OTCQB: MSCLF), a public biotech company developing new small molecule therapeutic approaches to improve the treatment of muscle diseases and disorders, announced today positive preliminary data showing SAT-3247 can improve skeletal muscle function in a mouse model of facioscapulohumeral muscular dystrophy (FSHD).
  • We look forward to presenting these data at the MDA Clinical and Scientific Conference 2024 and advancing SAT-3247 into clinical trials for Duchenne muscular dystrophy mid-year.”
    Neil Camarta, Co-Founder and CEO of the FSHD Canada Foundation, said “I’m very pleased.
  • I’m looking forward to working with Satellos to accelerate the development of this promising drug candidate, because time is muscle!”
    FSHD is the third most common muscular dystrophy behind Duchenne (& Beckers) and myotonic dystrophy.
  • FSHD is an adult onset muscular dystrophy that results in the progressive destruction of muscle tissue, owed to the erroneous expression of a gene product called DUX4.

Lexicon Enrolls First Patient in Phase 2b Progress Study of LX9211 in Diabetic Peripheral Neuropathic Pain (DPNP)

Retrieved on: 
Thursday, November 30, 2023

THE WOODLANDS, Texas, Nov. 30, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that it has enrolled the first patient in 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) studying LX9211, a potent, orally-delivered, selective, investigational small molecule inhibitor of adaptor-associated kinase 1 (AAK1).

Key Points: 
  • PROGRESS will enroll adult patients with a diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) with moderate to severe DPNP.
  • The primary endpoint of PROGRESS is a reduction of Average Daily Pain Score (ADPS), consistent with the primary endpoint achieved in the successful RELIEF-DPN-1 Phase 2a proof-of-concept study and, informed by regulatory feedback, the primary endpoint planned for Phase 3 studies of LX9211 in DPNP.
  • The placebo-controlled treatment period of PROGRESS is intended to identify the optimal dosing for Phase 3 studies.
  • The open-label extension is expected to run in parallel with planned next-stage Phase 3 studies, supporting long-term safety requirements for regulatory approval.

Satellos Bioscience Announces 2023 Q3 Financial Results and Operational Highlights

Retrieved on: 
Wednesday, November 22, 2023

Satellos Bioscience Inc. (TSXV: MSCL) (“Satellos” or the “Company”), a regenerative medicine company aimed at developing therapeutics that change the way degenerative muscle diseases are treated, announced today its financial results and operational highlights for the three months ending September 30, 2023.

Key Points: 
  • Satellos Bioscience Inc. (TSXV: MSCL) (“Satellos” or the “Company”), a regenerative medicine company aimed at developing therapeutics that change the way degenerative muscle diseases are treated, announced today its financial results and operational highlights for the three months ending September 30, 2023.
  • Satellos also announced that SAT-3247 would be nominated as the lead DC based on results generated by the Company during its preclinical studies.
  • Satellos had cash and cash equivalents of $44.3 million as of September 30, 2023, compared with $1.9 million at December 31, 2022.
  • Satellos’ interim condensed consolidated financial statements for the three and nine months ended September 30, 2023, and the related management’s discussion and analysis (MD&A) are available on SEDAR+ at www.sedarplus.ca .

Satellos Discloses Drug Target and Provides Development Update on Duchenne Muscular Dystrophy Program

Retrieved on: 
Tuesday, November 14, 2023

We have generated multiple series of small molecule inhibitors of AAK1 with pharmaceutical properties designed to meet our therapeutic objectives in treating Duchenne.

Key Points: 
  • We have generated multiple series of small molecule inhibitors of AAK1 with pharmaceutical properties designed to meet our therapeutic objectives in treating Duchenne.
  • SAT-3247 also exhibited improved oral bioavailability, target specificity, and tissue distribution, when compared directly to SAT-3153.
  • “The data in our Duchenne program continue to support our drug target, mechanism of action, and proprietary small molecule leads,” said Phil Lambert, Ph.D., Chief Scientific Officer of Satellos.
  • We are excited about the improved oral bioavailability, target selectivity, and tissue distribution that SAT-3247 has exhibited in these models.

Lexicon Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, August 3, 2023

THE WOODLANDS, Texas, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months ended June 30, 2023 and provided an update on key corporate milestones.

Key Points: 
  • “This was a an important and productive quarter for Lexicon with achievement of a transformational milestone for the company and important advancements in our business,” said Lonnel Coats, Lexicon’s chief executive officer.
  • The first late-stage study will be a Phase 2b dose optimization study, with start-up scheduled in the third quarter of 2023 and the initiation of dosing expected in the fourth quarter.
  • For the second quarters of 2023 and 2022, net loss included non-cash, stock-based compensation expense of $3.8 million and $2.8 million, respectively.
  • Lexicon management will hold a live conference call and webcast today at 5:00 pm ET / 4:00 pm CT to review its financial and operating results and to provide a general business update.

Lexicon to Present Study Results Relating to LX9211 and INPEFA™ (Sotagliflozin) at the American Diabetes Association’s 83rd Scientific Sessions

Retrieved on: 
Tuesday, June 20, 2023

THE WOODLANDS, Texas, June 20, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that clinical study results relating to LX9211, its investigational drug for the treatment of diabetic peripheral neuropathic pain, and INPEFA™ (sotagliflozin), its recently approved drug for heart failure, will be featured as Oral Presentations focused on treatment of complications of diabetes during the American Diabetes Association’s 83rd Scientific Sessions, June 23-26, 2023, in San Diego, California.

Key Points: 
  • THE WOODLANDS, Texas, June 20, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that clinical study results relating to LX9211, its investigational drug for the treatment of diabetic peripheral neuropathic pain, and INPEFA™ (sotagliflozin), its recently approved drug for heart failure, will be featured as Oral Presentations focused on treatment of complications of diabetes during the American Diabetes Association’s 83rd Scientific Sessions, June 23-26, 2023, in San Diego, California.
  • LX9211 has received Fast Track designation from the U.S. Food and Drug Administration for development in diabetic peripheral neuropathic pain, also known as DPNP.
  • On May 26, 2023, the FDA approved INPEFA, a once-daily oral tablet, to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with:
    type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.
  • Details of the presentations are as follows:
    LX9211, an Orally-Administered, Non-opioid, AAK1 Inhibitor for Painful Diabetic Peripheral Neuropathy: Results from a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study – an oral presentation, Friday, June 23, 5:30-5:45 p.m. PT, San Diego Convention Center, Room 24, presented by Rodica Pop-Busui, MD, PhD, Division of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor, MI
    The Efficacy of Sotagliflozin on Heart-Failure Related Outcomes is Independent of Baseline A1C – an oral presentation at the ADA Presidents’ Select Abstract Session, Sunday, June 25, 2:45-3:00 p.m. PT, San Diego Convention Center, Room 5, presented by Rahul Aggarwal, MD, Brigham & Women’s Hospital, Harvard Medical School, Boston, MA

Lexicon Pharmaceuticals Highlights Oral Presentation of Final Results From the RELIEF-DPN-1 Trial of LX9211 at the 16th Annual Pain Therapeutics Summit

Retrieved on: 
Tuesday, November 8, 2022

The presentation will describe the preclinical basis for the program, the framework of the trial, and an analysis of the final results from this successful proof-of-concept study.

Key Points: 
  • The presentation will describe the preclinical basis for the program, the framework of the trial, and an analysis of the final results from this successful proof-of-concept study.
  • Following the presentation, Dr. Patel will join Lexicon management on a live conference call and webcast at 5:00pm ET to discuss the study results.
  • The dial-in number for the conference call is 888-886-7786 and the conference ID for all callers is 28989106.
  • Preclinical studies of LX9211 demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain without affecting opiate pathways.

Lexicon Pharmaceuticals Announces Oral Presentations Relating To Its LX9211 Neuropathic Pain Program At The World Brain Disorders And Neuroscience Summit 2022

Retrieved on: 
Monday, October 24, 2022

We are excited to share these promising preclinical data, which we plan to submit for publication in a peer-reviewed journal.

Key Points: 
  • We are excited to share these promising preclinical data, which we plan to submit for publication in a peer-reviewed journal.
  • The RELIEF-DPN-1 study was the first of two Phase 2 proof-of-concept studies evaluating LX9211 in 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 has received Fast Track designation from the U.S. Food and Drug Administration for the development in diabetic peripheral neuropathic pain.

Lexicon Pharmaceuticals Highlights Scientific and Medical Presentations Relating to Its Successful Phase 2 Proof-Of-Concept Study of LX9211 in Painful Diabetic Neuropathy

Retrieved on: 
Tuesday, September 20, 2022

THE WOODLANDS, Texas, Sept. 20, 2022 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced a series of scientific and medical presentations describing the progression of its investigational drug LX9211 from discovery to translation in a clinical proof-of-concept study.

Key Points: 
  • We are excited to present these findings to the medical and scientific community and expect to communicate additional LX9211 clinical and preclinical data as they become available.
  • RELIEF-DPN-1 was a Phase 2 randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy, safety and pharmacokinetics of LX9211 in the treatment of painful diabetic neuropathy, also referred to as diabetic peripheral neuropathic pain.
  • The RELIEF-DPN-1 study was the first of two Phase 2 proof-of-concept studies evaluating LX9211 in neuropathic pain.
  • LX9211 has received Fast Track designation from the U.S. Food and Drug Administration for the development in diabetic peripheral neuropathic pain.