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Globe and Mail
10 hours ago
- Business
- Globe and Mail
Diabetes Clinical Trials Analysis 2025: EMA, PDMA, FDA Approvals, Therapies, Medication, NDA Approval, IND, Mechanism of Action, Route of Administration by DelveInsight
Diabetes Companies are vTv Therapeutics, Tonghua Dongbao Pharmaceutical, Eli Lilly and Company, Celon Pharma, Sciwind Biosciences, AstraZeneca, Suzhou Alphamab Co., Ltd., Neurodon, Abarceo Pharma, Chong Kun Dang Pharmaceutical and others. (Albany, USA) DelveInsight's, ' Diabetes Pipeline Insight 2025 ' report provides comprehensive insights about 200+ companies and 200+ pipeline drugs in the Diabetes pipeline landscape. It covers the Diabetes pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Diabetes therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Discover the latest drugs and treatment options in the Diabetes Pipeline. Dive into DelveInsight's comprehensive report today! @ Diabetes Pipeline Outlook Key Takeaways from the Diabetes Pipeline Report In April 2025, Gan & LEE Pharmaceuticals announced a study will be conducted to compare the efficacy, safety and patient-reported outcome of once-weekly GZR4 and once-daily Insulin Degludec with or without Non-Insulin Antidiabetic Agents in subjects with Type 2 Diabetes Mellitus (T2DM) treated with basal insulin. In March 2025, Dong-AST Co. Ltd announced a study is a multicenter, double-blind, active-controlled, randomized, parallel, phase IV clinical trial to evaluate the efficacy and safety of DA-2811 when added to ongoing metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control. In March 2025, Novo Nordisk A/S announced a study compares 2 medicines for type 1 and type 2 diabetes - faster aspart (a new medicine) and insulin aspart (a medicine doctors can already prescribe). Participants will either get faster aspart or insulin aspart (NovoRapid®) - which treatment is decided by chance. DelveInsight's Diabetes pipeline report depicts a robust space with 200+ active players working to develop 200+ pipeline therapies for Diabetes treatment. The leading Diabetes Companies such as vTv Therapeutics, Tonghua Dongbao Pharmaceutical, Eli Lilly and Company, Celon Pharma, Sciwind Biosciences, AstraZeneca, Suzhou Alphamab Co., Ltd., Neurodon, Abarceo Pharma, Chong Kun Dang Pharmaceutical and others. Promising Diabetes Therapies such as Aspirin, DA-2811, Forxiga, TG103, and others. Stay ahead with the most recent pipeline outlook for Diabetes. Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ Diabetes Treatment Drugs Emerging Diabetes Drugs Profile Cadisegliatin: vTv Therapeutics Cadisegliatin, also known as TTP399, is an innovative oral medication developed by vTv Therapeutics, designed as a liver-selective glucokinase activator. It aims to serve as an adjunctive therapy to insulin for individuals with type 1 diabetes (T1D). This drug has been recognized for its potential to improve glycemic control by enhancing hepatic glucose uptake and glycogen storage independently of insulin, addressing a critical need in diabetes management. Currently, the drug is in the Phase III stage of its clinical trial for the treatment of Diabetes. LY-3209590: Eli Lilly and Company Insulin efsitora alfa (LY3209590) is a once-weekly basal insulin, a fusion protein that combines a novel single-chain variant of insulin with a human IgG2 Fc domain. It is specifically designed for once-weekly subcutaneous administration, and with its low peak-to-trough ratio, it has the potential to provide more stable glucose levels (less glucose variability) throughout the week. Efsitora is in phase III development for adults with type 1 and 2 diabetes. THDB0206: Tonghua Dongbao Pharmaceutical BC Lispro (THDB0206) is an ultra-rapid-acting insulin analog developed by Tonghua Dongbao Pharmaceutical Co., Ltd. for the treatment of Diabetes. BC Lispro is designed to restore early-phase insulin secretion, which is often impaired in diabetic patients. This insulin analog utilizes a new formulation technology that allows for rapid absorption and action, mimicking the physiological pattern of insulin secretion after meals. Such characteristics are expected to reduce the risk of late postprandial hypoglycemia, providing patients with greater flexibility in managing their insulin injections. Currently, the drug is in the Phase III stage of its clinical trial for the treatment of Diabetes. CPL207280: Celon Pharma CPL207280 is a novel G-protein-coupled receptor 40 (GPR40) agonist under development for the treatment of Diabetes. CPL207280 acts as an agonist for GPR40, a receptor that plays a crucial role in enhancing glucose-stimulated insulin secretion from pancreatic beta cells. This mechanism is particularly beneficial for T2D patients, as it can improve glycemic control without the risk of hypoglycemia, a common side effect associated with other diabetes medications. Currently, the drug is in the Phase II stage of development to treat Diabetes. XW014: Sciwind Biosciences XW014 is an oral small molecule glucagon-like peptide-1 (GLP-1) receptor agonist developed by Sciwind Biosciences for the treatment of obesity and Diabetes (T2D). XW014 functions as a GLP-1 receptor agonist, which means it mimics the action of the GLP-1 hormone that is released after meals. This hormone plays a key role in regulating glucose metabolism by stimulating insulin secretion, inhibiting glucagon release, and promoting satiety. As an oral small molecule, XW014 offers advantages over traditional peptide-based GLP-1 therapies, such as ease of administration and the potential for combination therapies with other oral medications. Currently, the drug is in Phase I stage of its clinical trial for the treatment of Diabetes. KN056: Suzhou Alphamab Co., Ltd. KN-056 is a glucagon-like peptide-1 receptor (GLP-1R) modulator developed by Suzhou Alphamab Co., Ltd. for the treatment of Diabetes. KN-056 functions as a GLP-1R modulator, which means it targets the glucagon-like peptide-1 receptor. GLP-1 is a hormone that plays a key role in regulating glucose metabolism by stimulating insulin secretion, inhibiting glucagon release, and promoting satiety. By modulating the GLP-1 receptor, KN-056 aims to improve glycemic control in patients with Diabetes. Currently, the drug is in the Phase I stage of its clinical trial for the treatment of Diabetes. The Diabetes Pipeline Report Provides Insights into The report provides detailed insights about companies that are developing therapies for the treatment of Diabetes with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Diabetes Treatment. Diabetes Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. Diabetes Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Diabetes market Explore groundbreaking therapies and clinical trials in the Diabetes Pipeline. Access DelveInsight's detailed report now! @ New Diabetes Drugs and Medication Diabetes Companies vTv Therapeutics, Tonghua Dongbao Pharmaceutical, Eli Lilly and Company, Celon Pharma, Sciwind Biosciences, AstraZeneca, Suzhou Alphamab Co., Ltd., Neurodon, Abarceo Pharma, Chong Kun Dang Pharmaceutical and others. The Diabetes pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical Diabetes Products have been categorized under various Molecule types such as, Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Unveil the future of Diabetes Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight's expert analysis @ Diabetes Market Drivers and Barriers Scope of the Diabetes Pipeline Report Coverage- Global Diabetes Companies- vTv Therapeutics, Tonghua Dongbao Pharmaceutical, Eli Lilly and Company, Celon Pharma, Sciwind Biosciences, AstraZeneca, Suzhou Alphamab Co., Ltd., Neurodon, Abarceo Pharma, Chong Kun Dang Pharmaceutical and others. Diabetes Therapies- Aspirin, DA-2811, Forxiga, TG103, and others. Diabetes Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination Diabetes Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Get the latest on Diabetes Therapies and clinical trials. Download DelveInsight's in-depth pipeline report today! @ Diabetes Companies, Key Products and Unmet Needs Table of Content Introduction Executive Summary Diabetes: Overview Pipeline Therapeutics Therapeutic Assessment Diabetes– DelveInsight's Analytical Perspective Late Stage Products (Phase III) Cadisegliatin: vTv Therapeutics Drug profiles in the detailed report….. Mid-Stage Products (Phase II) CPL207280: Celon Pharma Drug profiles in the detailed report….. Early Stage Products (Phase I) KN056: Suzhou Alphamab Co., Ltd. Drug profiles in the detailed report….. Preclinical and Discovery Stage Products Drug name: Company name Drug profiles in the detailed report….. Inactive Products Diabetes Key Companies Diabetes Key Products Diabetes- Unmet Needs Diabetes- Market Drivers and Barriers Diabetes- Future Perspectives and Conclusion Diabetes Analyst Views Diabetes Key Companies Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Ankit Nigam Email: Send Email Phone: +19193216187 Address: 304 S. Jones Blvd #2432 City: Albany State: New York Country: United States Website:
Yahoo
15-05-2025
- Business
- Yahoo
vTv Therapeutics Announces 2025 First Quarter Financial Results and Provides Corporate Update
Ongoing screening in CATT1 Phase 3 trial evaluating cadisegliatin in patients with type 1 diabetes (T1D) Topline Phase 3 data for cadisegliatin expected in 2H 2026 HIGH POINT, N.C., May 15, 2025 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of cadisegliatin, a potential first-in-class oral adjunctive therapy to insulin being investigated for the treatment of type 1 diabetes (T1D), today reported financial results for the first quarter ended March 31, 2025, and provided an update on recent corporate developments. 'Our late stage cadisegliatin program is advancing with potential to be the first oral adjunct therapy for T1D,' said Paul Sekhri, Chairman, President and Chief Executive Officer of vTv Therapeutics. 'We reinitiated screening in our Phase 3 CATT1 study and, based upon the recent protocol amendment to shorten the study from 12 to 6 months, we expect topline Phase 3 data for cadisegliatin in the second half of 2026.' Recent Company Highlights Screening Reinitiated for Phase 3 Trial. In May 2025, vTv Therapeutics announced that screening has been reinitiated in the Company's CATT1 phase 3 trial evaluating cadisegliatin as an adjunctive therapy to insulin for treatment of type 1 diabetes (T1D). Topline data from the study is expected in the second half of 2026. Protocol Amendment for CATT1 Phase 3 Trial. In April, the Company submitted a protocol amendment to reduce the overall duration of the CATT1 trial from 12 to 6 months, which will expedite time to topline data by forgoing the additional 6-month safety assessment with no impact on original key endpoints. Also based on the amendment, continuous glucose monitors (CGM) will now be provided to participants. First Quarter 2025 Financial Results Cash Position: The Company's cash position as of March 31, 2025, was $31.1 million compared to $36.7 million as of December 31, 2024. Research & Development (R&D) Expenses: R&D expenses were $2.8 million and $2.6 million in each of the three months ended March 31, 2025, and 2024, respectively. The increase reflects higher indirect costs and other project-related expenses. This was partially offset by lower spending on cadisegliatin, primarily due to reduced clinical trial costs and drug manufacturing costs and lower spending on other projects. General & Administrative (G&A) Expenses: G&A expenses were $3.7 million and $4.0 million for each of the three months ended March 31, 2025, and 2024, respectively. The decrease was primarily due to decreases in payroll costs, legal expense and other operating costs. This was partially offset by an increase in share-based expense. Other Expense, Net: Other expense for the three months ended March 31, 2025, was immaterial. Other expense for the three months ended March 31, 2024, was $0.4 million and was driven by losses related to the change in the fair value of the outstanding warrants to purchase shares of our own stock issued to related parties. Net Loss: Net loss attributable to vTv shareholders for the three months ended March 31, 2025, was $5.1 million or $0.77 per basic share. Net loss attributable to vTv shareholders for the comparable period a year ago was $4.9 million or $1.17 per basic share. vTv Therapeutics Consolidated Balance Sheets(in thousands) March 31,2025 December 31,2024 (Unaudited) Assets Current assets: Cash and cash equivalents $ 31,059 $ 36,746 Prepaid expenses 742 1,192 Other current assets 115 175 Total current assets 31,916 38,113 Property and equipment, net 19 28 Operating lease right-of-use assets 92 125 Total assets $ 32,027 $ 38,266 Liabilities and Stockholders' Equity Current liabilities: Accounts payable and accrued expenses $ 4,191 $ 5,027 Current portion of operating lease liabilities 125 169 Total current liabilities 4,316 5,196 Contract liabilities, net of current portion 18,669 18,669 Warrant liability, related party 85 57 Warrant liability 60 43 Total liabilities 23,130 23,965 Commitments and contingencies Stockholders' equity: Class A Common Stock 26 26 Class B Common Stock 6 6 Additional paid-in capital 312,698 311,885 Accumulated deficit (304,810 ) (299,718 ) Total stockholders' equity attributable to vTv Therapeutics Inc. 7,920 12,199 Noncontrolling interest 977 2,102 Total stockholders' equity 8,897 14,301 Total liabilities and stockholders' equity $ 32,027 $ 38,266 vTv Therapeutics Consolidated Statements of Operations(in thousands, except per share data) Three Months EndedMarch 31, 2025 2024 (Unaudited) Revenue $ — $ 1,000 Operating expenses: Research and development 2,830 2,649 General and administrative 3,673 3,978 Total operating expenses 6,503 6,627 Operating loss (6,503 ) (5,627 ) Interest income 331 79 Other expense, net (45 ) (371 ) Loss before income taxes and noncontrolling interest (6,217 ) (5,919 ) Income tax provision — 100 Net loss before noncontrolling interest (6,217 ) (6,019 ) Less: net loss attributable to noncontrolling interest (1,125 ) (1,154 ) Net loss attributable to vTv Therapeutics Inc. $ (5,092 ) $ (4,865 ) Net loss attributable to vTv Therapeutics Inc. common shareholders $ (5,092 ) $ (4,865 ) Net loss per share of vTv Therapeutics Inc. Class A common stock, basic and diluted $ (0.77 ) $ (1.17 ) Weighted average number of vTv Therapeutics Inc. Class A common stock, basic and diluted 6,582,844 4,141,492 About Cadisegliatin Cadisegliatin (TTP399) is a novel, oral small molecule, liver selective glucokinase activator being investigated as a potential first-in-class oral adjunctive treatment to insulin for type 1 diabetes (T1D). In nonclinical studies, cadisegliatin, acting selectively on the liver, increased the activity of glucokinase independently from insulin which supports clinical investigation of improvement in glycemic control through hepatic glucose uptake and glycogen storage. Cadisegliatin is under investigation and the safety and efficacy have not been established. There is no guarantee that this product will receive health authority approval or become commercially available for the use being investigated. About vTv Therapeutics vTv Therapeutics Inc. is a late stage biopharmaceutical company focused on developing novel oral, small molecule drug candidates intended to help treat millions with chronic diseases. vTv's clinical pipeline is led by cadisegliatin, a potential first-in-class oral adjunctive therapy to insulin being investigated for the treatment of type 1 diabetes. Forward-Looking Statement This release contains forward-looking statements, which involve risks and uncertainties. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms 'anticipate,' 'believe,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'will,' 'would' and, in each case, their negative or other various or comparable terminology. All statements other than statements of historical facts contained in this release, including statements regarding the timing of our clinical trials, our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause our results to vary from expectations include those described under the heading 'Risk Factors' in our Annual Report on Form 10-K and our other filings with the SEC. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this release and, except as required by law, we undertake no obligation to update or review publicly any forward-looking statements, whether a result of new information, future events or otherwise after the date of this release. We anticipate that subsequent events and developments will cause our views to change. Our forward-looking statements do not reflect the potential impact of any future acquisitions, merger, dispositions, joint ventures, or investments we may undertake. We qualify all our forward-looking statements by these cautionary statements. Investor ContactSandya von der WeidLifeSci Advisors, LLCsvonderweid@ Media Contact Caren BegunTellMed in to access your portfolio
Yahoo
17-03-2025
- Business
- Yahoo
vTv Therapeutics Soars 43% as FDA Lifts Clinical Hold on Diabetes Drug Trial
vTv Therapeutics (VTVT, Financials) surged 42.99% to $21.23 on Monday after the U.S. Food and Drug Administration lifted a clinical hold on the company's development program for cadisegliatin, an experimental oral therapy for type 1 diabetes. Warning! GuruFocus has detected 4 Warning Signs with VTVT. Following an adjustment to cut its length from 12 months to six months, the business intends to start its Phase 3 CATT1 study. According to a statement by vTv Therapeutics, the updated schedule seeks to hasten the gathering of topline data and speed future regulatory as an oral supplement to insulin treatment, cadisegliatin is a glucokinase activator specific for the liver. The business claims that the medicine has been generally well tolerated after testing over 500 people for up to six a chromatographic signal in a metabolism study not able to be resolved with conventional mass spectrometry, the FDA has put a clinical halt on the experiment in July 2024. At the time, no patients had been registered for the experiment; earlier research had not shown any appreciable safety issues. Following vTv's entire response to the FDA, which indicated the signal was an experimental artifact, the clinical hold was released March main endpoint, which gauges degrees of moderate to severe hypoglycemia at six months, will not change with the adjustment to the research protocol. The revised scheme eliminates an extra six-month safety monitoring period, biopharmaceutical business vTv Therapeutics is studying cadisegliatin as a first-in-class type 1 diabetes treatment. The business has not said when it hopes to release topline findings from the CATT1 study. This article first appeared on GuruFocus.
