Market Newsdesk

CARMEL, Ind., Sept. 26, 2023 (GLOBE NEWSWIRE) — NeurAxis, Inc. (“NeurAxis,” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies that address chronic and debilitating conditions in children and adults, today announced the results of a retrospective comparative study of adolescent patients with functional abdominal pain disorders (FAPD) treated with IB-Stim™ therapy or standard of care medications, amitriptyline (tricyclic antidepressant) or cyproheptadine (antihistamine). Led by the Cincinnati Children’s Hospital Medical Center, the comparative study concluded that IB-Stim™ may be a good non-pharmacologic alternative for FAPD.

The publication, Percutaneous electrical nerve field stimulation compared to standard medical therapy in adolescents with functional abdominal pain disorders, featured in the September 19^th 2023 Frontiers in Pain Research, reviewed records of 101 adolescents treated with 4 weeks of IB-Stim™, amitriptyline or cyproheptadine. In the study, 59% of patients in the IB-Stim group had failed prior standard medical therapy. Evaluated outcome measures included validated pediatric questionnaires using Abdominal Pain Index (API), Nausea Severity Scale (NSS) and Functional Disability Inventory (FDI) at baseline and at 3-month follow up. The comparative analysis noted that:

• at follow up, IB-Stim™ therapy showed improvements in abdominal pain (p=0.001) and functional disability (p=0.048) compared to baseline, while amitriptyline showed improvements in abdominal pain (p=0.034);
• in a comparison of outcomes between groups, IB-Stim™ was more effective than cyproheptadine in improving abdominal pain (p=0.04) and did not differ from amitriptyline (p=0.64). Nausea scores did not differ between groups (p>0.05); and
• disability scores between groups were only more effective for amitriptyline vs. cyproheptadine (p=0.03). Disability scores did not differ from amitriptyline compared with IB-Stim™ (p=0.21).

Dr. Adrian Miranda, Chief Medical Officer of NeurAxis, said, “It is exciting to see a comparative evaluation of IB-Stim™ with standard medical therapy. Although amitriptyline and cyproheptadine are amongst the most commonly used medications to treat functional abdominal pain, there is a lack of clinical evidence for using these medications in children and it may be that these medications just don’t perform as well as we think”. Dr. Miranda added, “it is difficult to know how a drug will perform in the real world, even after a positive clinical trial, because drugs are metabolized differently. This is one of the reasons drug trials need to be very large. More importantly, side effects need to be monitored closely, particularly in children. Nonetheless, we are pleased that IB-Stim™ continues to show positive clinical results with minimal to no side-effects, making it an effective FAPD treatment option.”

Forward-Looking Statements

Certain statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. There are a number of important factors that could cause actual results, developments, business decisions or other events to differ materially from those contemplated by the forward-looking statements in this press release. These factors include, among other things, the conditions in the U.S. and global economy, the trading price and volatility of the Company’s stock, public health issues or other events, the Company’s compliance with applicable laws, the results of the Company’s clinical trials and perceptions thereof, as well as factors described in the Risk Factors section of NeurAxis’s public filings with the Securities and Exchange Commission (SEC). Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date of this press release and, except to the extent required by applicable law, the Company undertakes no obligation to update or revise these statements, whether as a result of any new information, future events and developments or otherwise.

About NeurAxis, Inc.

NeurAxis, Inc., is a medical technology company focused on neuromodulation therapies to address chronic and debilitating conditions in children and adults. NeurAxis is dedicated to advancing science and leveraging evidence-based medicine to drive adoption of its IB-Stim™ therapy, which is its proprietary Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, by the medical, scientific, and patient communities. IB-Stim™ is FDA cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents 11-18 years old. Additional clinical trials of PENFS in multiple pediatric and adult conditions with large unmet healthcare needs are underway. For more information, please visit http://neuraxis.com/.

This page discusses ongoing research activities with percutaneous electrical nerve field stimulator (PENFS) technology. Please note, the research being described includes information about technology and intended uses of that technology which have not been reviewed or approved/cleared by the U.S. FDA, and is being provided for informational purposes only. NeurAxis does not recommend or suggest the use of its PENFS IB-Stim™ device for uses beyond those that are cleared by the U.S. FDA. See https://ibstim.com/important-information/.

Contacts:

Company

NeurAxis, Inc.

[email protected]

Investor Relations

Gilmartin Group

[email protected]

LIMASSOL, Cyprus, Sept. 26, 2023 (GLOBE NEWSWIRE) — Castor Maritime Inc. (NASDAQ: CTRM), (“Castor” or the “Company”), a diversified global shipping company, announces that on September 22, 2023, the Company entered into an agreement with an unaffiliated third party for the sale of the M/V Magic Argo, a 2009-built Kamsarmax bulk carrier, for a price of $15.75 million. The vessel is expected to be delivered to her new owners during the fourth quarter of 2023.

The Company expects to record during the fourth quarter of 2023 a net gain of approximately $3.0 million, excluding any transaction-related costs.

The Company also announces that the previously announced sale of the M/V Magic Moon was terminated following the buyer’s failure to take delivery of the vessel. Accordingly, the Company will retain the vessel and not receive its purchase price of $13.95 million, that would have incorporated a net gain before transaction costs of $5.3 million. The Company is seeking appropriate compensation pursuant to the terms of the Memorandum of Agreement for this sale.

About Castor Maritime Inc.

Castor Maritime Inc. is an international provider of shipping transportation services through its ownership of oceangoing cargo vessels.

Castor owns a fleet of 20 vessels, with an aggregate capacity of 1.6 million dwt, currently consisting of 1 Capesize, 6 Kamsarmax, which includes the M/V Magic Argo, 11 Panamax dry bulk vessels, 2 2,700 TEU containership vessels.

For more information please visit the Company’s website at www.castormaritime.com. Information on our website does not constitute a part of this press release.

Cautionary Statement Regarding Forward-Looking Statements

Matters discussed in this press release may constitute forward-looking statements. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements, which are other than statements of historical facts. We are including this cautionary statement in connection with this safe harbor legislation. The words “believe”, “anticipate”, “intend”, “estimate”, “forecast”, “project”, “plan”, “potential”, “will”, “may”, “should”, “expect”, “pending” and similar expressions identify forward-looking statements. The forward-looking statements in this press release are based upon various assumptions, many of which are based, in turn, upon further assumptions, including without limitation, our management’s examination of current or historical operating trends, data contained in our records and other data available from third parties. Although we believe that these assumptions were reasonable when made, because these assumptions are inherently subject to significant uncertainties and contingencies which are difficult or impossible to predict and are beyond our control, we cannot assure you that we will achieve or accomplish these forward-looking statements, including these expectations, beliefs or projections. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. In addition to these important factors, other important factors that, in our view, could cause actual results to differ materially from those discussed in the forward‐looking statements include factors and uncertainties related to the Company’s and its counterparty’s ability to consummate the transaction discussed herein or the occurrence of any event, change or other circumstance that could cause us to record a different net gain than expected on the sale of the M/V Magic Argo, factors and uncertainties in connection with the effects of the Company’s spin-off transaction or any similar transaction, our business strategy, dry bulk and tanker market conditions and trends, the rapid growth of our fleet, the consummation of any sale of any of our vessels, our relationships with our current and future service providers and customers, our ability to borrow under existing or future debt agreements or to refinance our debt on favorable terms and our ability to comply with the covenants contained therein, our continued ability to enter into time or voyage charters with existing and new customers and to re-charter our vessels upon the expiry of the existing charters, changes in our operating and capitalized expenses, our ability to fund future capital expenditures and investments in the acquisition and refurbishment of our vessels, instances of off-hire, future sales of our securities in the public market and our ability to maintain compliance with applicable listing standards, volatility in our share price, potential conflicts of interest involving members of our board of directors, senior management and certain of our service providers that are related parties, general domestic and international political conditions or events (including “trade wars”, global public health threats and major outbreaks of disease), existing or future disputes, proceedings or litigation, including the outcome or costs associated with the Company’s efforts to recover compensation and damages in relation to the terminated sale of the M/V Magic Moon (as discussed herein), changes in seaborne and other transportation, changes in governmental rules and regulations or actions taken by regulatory authorities, and the impact of adverse weather and natural disasters. Please see our filings with the Securities and Exchange Commission for a more complete discussion of these and other risks and uncertainties. The information set forth herein speaks only as of the date hereof, and we disclaim any intention or obligation to update any forward‐looking statements as a result of developments occurring after the date of this communication.

CONTACT DETAILS

For further information please contact:

Petros Panagiotidis
Castor Maritime Inc.
Email: [email protected] 

Media Contact:
Kevin Karlis
Capital Link
Email: [email protected] 

INPEFA



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(sotagliflozin) recently approved by FDA for treatment of heart failure

LX9211 is an investigational, non-opioid treatment for diabetic peripheral neuropathic pain

THE WOODLANDS, Texas, Sept. 26, 2023 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced several upcoming Lexicon-supported data presentations related to heart failure (HF), type 1 diabetes (T1D), and diabetic peripheral neuropathic pain (DPNP). The oral presentations will be made at the 59^th Annual Meeting of EASD, October 2-6, 2023, in Hamburg, Germany and online.

Details of the presentations are as follows:

• LX9211 in individuals with painful diabetic peripheral neuropathy: results from a randomised, double-blind, placebo-controlled, parallel-group, multicentre study – an oral presentation, Tuesday, October 3, 11:30 – 11:45 a.m. CEST, Mumbai Hall and online, presented by Rodica Pop-Busui, MD, PhD, the Larry D Soderquist Professor of Diabetes, Vice Chair of Clinical Research Department of Internal Medicine, Director Clinical Research, Caswell Diabetes Institute, University of Michigan.

• Factors associated with changes in beta hydroxybutyrate with sotagliflozin in adults with type 1 diabetes – a short oral discussion, Tuesday, October 3, 1:45 – 2:45 p.m., Short Oral Event B and online, presented by Schafer Boeder, M.D., University of California, San Diego.

• Temporal shift in heart failure medications prescribed to hospitalised patients with and without diabetes in a large US integrated health system – a short oral discussion, Wednesday, October 4, 2:00 – 3:00 p.m. CEST, Short Oral Event D and online, presented by Craig Granowitz, M.D., Ph.D., senior vice president and chief medical officer, Lexicon Pharmaceuticals.

On May 26, 2023, the U.S. Food and Drug Administration 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:

• heart failure or
• type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.

LX9211 has received Fast Track designation from the U.S. Food and Drug Administration for development in DPNP. Lexicon is preparing to advance LX9211 into late-stage development in a clinical program directed towards an application for regulatory approval in DPNP. The first late-stage study will be a Phase 2b dose optimization study, with study planning underway and initiation of dosing expected before the end of 2023. The Phase 2b study includes an extension to run in parallel with planned next-stage Phase 3 studies.

“We look forward to presenting relevant data from the most advanced programs in Lexicon’s portfolio of approved and investigational agents,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. “These presentations at EASD will help generate greater awareness of these programs and their potential to help patients across various therapeutic areas.”

About INPEFA

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(sotagliflozin)

Discovered using Lexicon’s unique approach to gene science, INPEFA (sotagliflozin) is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose reabsorption by the kidney and SGLT1 is responsible for glucose absorption in the gastrointestinal tract. INPEFA has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients.

INDICATION

INPEFA is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with:

• heart failure or
• type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors

IMPORTANT SAFETY INFORMATION

Dosing: Assess renal function and volume status and, if necessary, correct volume depletion prior to initiation of INPEFA. INPEFA dosing for patients with decompensated heart failure may begin when patients are hemodynamically stable, including when hospitalized or immediately upon discharge.

Contraindications: INPEFA is contraindicated in patients with hypersensitivity to any component.

Warnings and Precautions:

Ketoacidosis: INPEFA increases the risk of ketoacidosis in patients with type 1 diabetes mellitus (T1DM). Type 2 diabetes mellitus (T2DM) and pancreatic disorders are also risk factors. The risk of ketoacidosis may be greater with higher doses. There have been postmarketing reports of fatal events of ketoacidosis in patients with type 2 diabetes using sodium glucose transporter 2 (SGLT2) inhibitors. Before initiating INPEFA, assess risk factors for ketoacidosis. Consider ketone monitoring in patients with T1DM and consider ketone monitoring in others at risk for ketoacidosis, and educate patients on the signs/symptoms of ketoacidosis. Patients receiving INPEFA may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis.

Assess patients who present with signs and symptoms of metabolic acidosis or ketoacidosis, regardless of blood glucose level. If suspected, discontinue INPEFA, evaluate, and treat promptly. Monitor patients for resolution of ketoacidosis before restarting INPEFA.

Volume Depletion: INPEFA can cause intravascular volume depletion which may sometimes manifest as symptomatic hypotension or acute transient changes in creatinine. There have been post-marketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients with type 2 diabetes mellitus receiving SGLT2 inhibitors. Patients with impaired renal function (eGFR < 60 mL/min/1.73 m2), elderly patients, or patients on loop diuretics may be at increased risk for volume depletion or hypotension. Before initiating INPEFA in patients with one or more of these characteristics, assess volume status and renal function, and monitor for signs and symptoms of hypotension during therapy.

Urosepsis and Pyelonephritis: Treatment with SGLT2 inhibitors, including INPEFA, increases the risk for urinary tract infections. Serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization have been reported. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly.

Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues: Insulin and insulin secretagogues are known to cause hypoglycemia. INPEFA may increase the risk of hypoglycemia when combined with insulin or an insulin secretagogue. Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used with INPEFA.

Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Reports of Fournier’s Gangrene, a rare but serious and life-threatening necrotizing infection requiring urgent surgical intervention, have been identified in post-marketing surveillance in patients with diabetes mellitus receiving SGLT2 inhibitors. Assess patients who present with pain, tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, start treatment immediately with broad-spectrum antibiotics and, if necessary, surgical debridement. Discontinue INPEFA, closely monitor patient signs and symptoms, and provide appropriate alternative therapy for heart failure.

Genital Mycotic Infections: INPEFA increases the risk of genital mycotic infections. Monitor and treat as appropriate.

Urinary Glucose Test and 1,5-anhydroglucitol (1,5-AG) Assay: these are not reliable for patients taking SGLT2 inhibitors. Use alternative testing methods to monitor glucose levels.

Common Adverse Reactions: the most commonly reported adverse reactions (incidence ≥ 5%) were urinary tract infection, volume depletion, diarrhea, and hypoglycemia.

Drug Interactions:

• Digoxin: Monitor patients appropriately as there is an increase in the exposure of digoxin when coadministered with INPEFA 400 mg.
• Uridine 5′-diphospho-glucuronosyltransferase (UGT) Inducer: The coadministration of rifampicin, an inducer of UGTs, with sotagliflozin resulted in a decrease in the exposure of sotagliflozin.
• Lithium: Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Monitor serum lithium concentration more frequently during INPEFA initiation and with dosage changes.

Use in Specific Populations:

• Pregnancy and Lactation: INPEFA is not recommended during the second and third trimesters of pregnancy, nor while breastfeeding.
• Geriatric Use: No INPEFA dosage change is recommended based on age. No overall differences in efficacy were detected between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients may be at increased risk for volume depletion adverse reactions, including hypotension.
• Renal Impairment: INPEFA was evaluated in patients with chronic kidney disease (eGFR 25 to 60 mL/min/1.73 m²) and in patients with heart failure with eGFR <60 mL/min/1.73 m². The safety profile of INPEFA across eGFR subgroups in these studies was consistent with the known safety profile. There was an increase in volume-related adverse events (e.g., hypotension, dizziness) in patients with eGFR <30 mL/min/1.73m² relative to the overall safety population. Efficacy and safety studies with INPEFA did not enroll patients with an eGFR less than 25 mL/min/1.73 m2 or on dialysis. After starting therapy in the studies, patients were discontinued if eGFR fell below 15 mL/min/1.73 m2 or were initiated on chronic dialysis.
• Hepatic Impairment: INPEFA is not recommended in patients with moderate or severe hepatic impairment.

Click here for full Prescribing Information.

About LX9211

Discovered using Lexicon’s unique approach to gene science, LX9211 is a potent, orally delivered, selective, investigational small molecule inhibitor of adaptor-associated kinase 1 (AAK1). Lexicon identified AAK1 in its target discovery efforts as a promising approach for the treatment of neuropathic pain and identified LX9211 and another development candidate in a neuroscience drug discovery alliance with Bristol-Myers Squibb from which Lexicon holds exclusive development and commercialization rights. 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 development in diabetic peripheral neuropathic pain.

About Lexicon Pharmaceuticals

Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through its Genome5000™ program, 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 diseases safely and effectively. Lexicon has advanced multiple medicines to market and has a pipeline of promising drug candidates in heart failure, neuropathic pain, diabetes and metabolism and other indications. For additional information, please visit www.lexpharma.com.

Safe Harbor Statement

This press release contains “forward-looking statements,” including statements relating to the therapeutic and commercial potential, research and clinical development and regulatory status of INPEFA

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(sotagliflozin) and LX9211. In addition, this press release also contains forward looking statements relating to Lexicon’s financial position and long-term outlook on its business, growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully commercialize INPEFA in heart failure on the timeline and/or at the prices currently contemplated or at all, conduct preclinical and clinical development and obtain necessary regulatory approvals of INPEFA (in other indications), LX9211 and its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2022 and other subsequent disclosure documents filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

For Investor Inquiries:
Investor Relations
Lexicon Pharmaceuticals, Inc.
[email protected]

For Media Inquiries:
Alina Cocuzza
Lexicon Pharmaceuticals, Inc.
[email protected]