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.

SAN DIEGO, CA, USA and LONDON, UK I August 08, 2024 I Conduit Pharmaceuticals Inc. (Nasdaq: CDT ) (“Conduit” or the “Company”), today announced that the Company has entered into an agreement with AstraZeneca to exclusively license rights to develop AZD1656 and AZD5658, both HK-4 glucokinase activators, and AZD5904, a myeloperoxidase inhibitor (MPO). AstraZeneca had progressed AZD1656 and AZD5904 through Phase 1 clinical trials. Conduit initially intends to conduct Phase II clinical trials on clinical candidates AZD1656 and AZD5658 in 2024 for applications in autoimmune disorders, a category which affect an estimated 10% of the population 1 . Under the terms of the License Agreement, AstraZeneca will grant Conduit an exclusive license to both AZD1656 and AZD5658 for all human indications, as well as an exclusive license to AZD5904 for use in Idiopathic Male Infertility. As part of the License Agreement, AstraZeneca will be issued shares of common stock in Conduit, and Conduit will also pay AstraZeneca a share of sublicense revenues, including upfront payments, milestones, and royalties received from future partners. AstraZeneca will share pre-clinical and clinical data on the assets and supply Conduit with certain quantities of AZD1656, AZD5904, and AZD5658 from its inventory. The License Agreement also includes provisions for the transfer of know-how related to AZD1656, AZD5658 and AZD5904 from AstraZeneca to Conduit. AstraZeneca has been granted a right of first negotiation to develop, manufacture, and commercialize the licensed compounds if Conduit seeks to assign, license, or grant such rights to a third party. Through the License Agreement, Conduit will analyze existing clinical data and initiate Phase II trials. Conduit believes this will fast-track the development of these compounds and bring innovative new medicines to patients facing substantial unmet needs. “We are delighted to have entered into an agreement with AstraZeneca to secure the rights to develop AZD1656, AZD5658, and AZD5904. The potential of these assets to become important first-in-class medicines for patients is promising. Given the data from AstraZeneca’s clinical trials, we believe there is a strong rationale to initiate Phase II studies in multiple indications to progress to commercialization of these assets,” said Dr. David Tapolczay, Chief Executive Officer of Conduit. Conduit departs from the traditional business model of shepherding assets through an entire commercial lifecycle by acquiring assets that have already undergone pre-clinical and clinical testing. The Company works towards accelerating the assets through Phase II trials and, if successful, intends to seek exits through third-party license opportunities. About Conduit Pharmaceuticals 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 II-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-thelancet-com.libproxy1.nus.edu.sg/journals/lancet/article/PIIS0140-6736(23)00457-9/abstract SOURCE: Conduit Pharmaceuticals

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.