glucokinase

conduit Pharmaceuticals announces plans to initiate Phase 2a trials in both systemic lupus erythematosus and ANCA-associated vasculitis for its lead clinical candidate, AZD1656 AZD1656, a HK-4 glucokinase activator initially developed by AstraZeneca for diabetes, is now being repurposed by Conduit for autoimmune disorders, leveraging its established safety profile and targeted immune-modulating effects Aug. 12, 2024 -- Conduit Pharmaceuticals Inc. (Nasdaq: CDT) (“Conduit” or the “Company”), today announced the selection of initial indications for its lead clinical candidate, HK-4 glucokinase activator AZD1656 licensed from AstraZeneca on August 7, 2024. Conduit intends to initiate Phase 2a clinical trials to evaluate AZD1656 for the treatment of systemic lupus erythematosus (including lupus nephritis) and ANCA-associated vasculitis. This represents a significant milestone in the development of AZD1656, underscoring Conduit’s commitment to address unmet medical needs and its confidence in the asset's potential to impact patient outcomes positively. Carrying out Phase 2a, double-blind, placebo-controlled trials in patients suffering from systemic lupus erythematosus, inclusive of lupus nephritis patients, and patients suffering from ANCA-associated vasculitis, will enable Conduit to assess the potential of AZD1656 across the full spectrum of lupus patients. Simultaneously, we will evaluate the potential of AZD1656 across the broader aspects of autoimmune disorders. Originally developed by AstraZeneca through Phase 2b for diabetes mellitus, AZD1656 is a highly specific glucokinase activator that has undergone extensive safety testing, involving over 1,000 patients, in more than 20 trials. Conduit envisions AZD1656 as a potential cornerstone asset in the autoimmune sector, leveraging its established safety profile and targeted mechanism of action to activate the patient’s immune system and mitigate harmful inflammation. “Having reviewed the extensive data, we are delighted to advance AZD1656 into a new therapeutic area targeting systemic lupus erythematosus and ANCA-associated vasculitis,” said Dr. Freda Lewis-Hall, Chair of the Board of Directors at Conduit. “With its potential to become a first-in-class therapy for autoimmune diseases, AZD1656 represents a significant leap forward in our mission to develop ground-breaking treatments that could transform the landscape of autoimmune care and provide innovative treatments that can truly make a difference to patients.” Lupus affects over 5 million people worldwide, including 1.5 million Americans1. Yet, despite significant progress in the clinical understanding of the disease, treatment still relies heavily on the use of corticosteroids and non-specific immunosuppressants, widely known for their potentially severe side effects with long term use. Given the wide-ranging clinical manifestations of lupus there is a clear unmet need for safer treatments applicable to all patients. The global market size for lupus treatments, including systemic lupus erythematosus (SLE) and other lupus-related conditions, was estimated to be around $2.7 billion in 2024. This market is expected to grow significantly, reaching approximately $4.9 billion by 2030 with a compound annual growth rate (CAGR) of approximately 8.9%2. In addition, the market size of ANCA-associated vasculitis was highest in the U.S. among the seven major markets in 2023, accounting for approximately $620 million, and is expected to experience significant growth by 20323. Conduit is a multi-asset, clinical stage, disease-agnostic life science company delivering an efficient model for compound development. Conduit both acquires and funds the development of Phase 2-ready assets and then seeks an exit through third-party license deals following successful clinical trials. Led by a highly experienced team of pharmaceutical executives including Dr. David Tapolczay and Dr. Freda Lewis-Hall, this novel approach is a departure from the traditional pharma/biotech business model of taking assets through regulatory approval. 1 https://www.pfizer.com/disease-and-conditions/lupus#:~:text=Lupus%20is%20a%20global%20disease,in%20the%20United%20States%20alone.&text=Its%20prevalence%20varies%20significantly%20between%20regions. 2 https://www.marketresearchfuture.com/reports/systemic-lupus-erythematosus-treatment-market-8500 3 https://finance.yahoo.com/news/anca-associated-vasculitis-industry-epidemiology-084800557.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAANkxj8q0WJx_FXr2sjJIlSmylTMmxaJeUARmiWNMn6zifDwMsjRLRxrwchkkTJpnSgmOepq9_4F4VcuFTnK9614lev4EU5ZewxV0sp-_HWjYRNJpQXDsL5LmvJKBUGk93MU9si4jNJXm1dHmn9v7YN7MTrQFHB0yTldyLyE3iDHJ The content above comes from the network. if any infringement, please contact us to modify.

vTv Therapeutics announced that the FDA has placed a clinical hold on its cadisegliatin program, including an ongoing phase 3 trial for type 1 diabetes. The hold was made due to discovery of a chromatographic signal in a recent human ADME study of cadisegliatin that could not be resolved by standard mass spectroscopy. The FDA requires an in vitro study to characterize this signal before the program can resume. The hold includes the CATT1 phase 3 study, though no patients had been dosed in the trial at the time of the hold, and previous clinical studies did not reveal any safety concerns. Cadisegliatin is an oral, liver-selective glucokinase activator that has been well-tolerated in over 500 subjects with up to six months of treatment. Cadisegliatin is designed to increase glucokinase activity in the liver independently of insulin, aiming to improve glycemic control through enhanced hepatic glucose uptake and glycogen storage. The North Carolina-based biotech has focused on developing novel oral, small molecule drug candidates for chronic diseases. Cadisegliatin leads its clinical pipeline as a potential adjunctive therapy to insulin for type 1 diabetes.

HIGH POINT, N.C., July 26, 2024 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late stage biopharmaceutical company with an innovative clinical portfolio of small molecules and lead program in diabetes, today announced that the United States Food and Drug Administration (FDA) has placed a clinical hold on the cadisegliatin clinical program which includes the ongoing CATT1 Phase 3 trial in type 1 diabetes. Cadisegliatin is an oral, liver selective, glucokinase activator that has been well-tolerated in over 500 subjects to date with up to six months of treatment. The clinical hold was based on the discovery of a chromatographic signal in a recent human absorption, distribution, metabolism, and excretion (ADME) study of cadisegliatin that could not be resolved by standard mass spectroscopy. The Agency requires a single in vitro study to characterize this signal before the cadisegliatin program can resume. No patient had been dosed in CATT1 at the time of the clinical hold, and past clinical studies did not reveal any clinically concerning safety issues. “Patient safety is our top priority, and we appreciate the thoroughness of the FDA to better understand this signal. We are working diligently with the Agency to resolve the clinical hold and resume enrollment as quickly as possible,” said Paul Sekhri, Chairman, President and Chief Executive Officer of vTv Therapeutics. “Cadisegliatin demonstrated compelling efficacy and a favorable safety profile in over 500 subjects dosed to date, and we are highly encouraged at the potential of cadisegliatin to improve glycemic control and be a much-needed oral therapy for type 1 diabetes.” About CadisegliatinCadisegliatin (TTP399) is a novel, oral small molecule, liver selective glucokinase activator with first-in- class potential as an adjunct treatment for type 1 diabetes (T1D). Selectively acting on the liver, cadisegliatin increases the activity of glucokinase independently from insulin to improve glycemic control through hepatic glucose uptake and glycogen storage. About vTv TherapeuticsvTv Therapeutics Inc. is a late stage biopharmaceutical company focused on developing novel oral, small molecule drug candidates to help treat millions with chronic diseases. vTv’s clinical pipeline is led by cadisegliatin, a potential first-in-class adjunctive therapy to insulin for the treatment of type 1 diabetes. Forward-Looking StatementThis 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 as 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 of our forward-looking statements by these cautionary statements. ContactAshley Robinson LifeSci Advisors, LLCarr@lifesciadvisors.com