ZSYM-008

New cognition/function and extensive plasma biomarker results of T3D-959 treatment from the Phase 2 PIONEER trial, in a modified intent-to treat population of mild to moderate Alzheimer's patients will be presented at the upcoming Alzheimer's Association International Conference (AAIC) in Philadelphia, PA from July 28 to August 1. T3D-959 is a novel, orally delivered, once-a-day, small molecule drug candidate, designed to activate two nuclear receptors regulating brain glucose energy and lipid metabolism to improve brain health and function. RESEARCH TRIANGLE PARK, N.C., July 24, 2024 /PRNewswire/ -- T3D Therapeutics, Inc., a clinical stage drug development company engaged in the development of a new orally administered treatment for Alzheimer's disease (AD), today announced that CEO, John Didsbury, will be presenting new Phase 2 results in a modified intent-to-treat population of mild to moderate Alzheimer's patients at AAIC. The poster presentation will take place on Sunday, July 28th in Philadelphia, PA. Presentation Details: Continue Reading A Novel Way to Reduce Alzheimer's Amyloid Plaque Burden, Phase 2 Clinical Trial Results of T3D-959 Presented at AAIC Post this Title: Phase 2 PIONEER Trial of Oral T3D-959 for the Treatment of Patients Diagnosed with Mild-to-Moderate Alzheimer's Disease: New Results in a Modified Intent-to-Treat Population Session: Developing Topics: Drug Development Poster Number: Sunday-798 Abstract Number: 95625 Date/Time: July 28, 2024, 8:00am-4:15pm (ET) Location: Pennsylvania Convention Center, Exhibit Hall (Hall BC) Presenter, John Didsbury states, "AD is a disease that encompasses a plethora of neurodegenerative 'triggers' including beta amyloid plaques, tau neurofibrillary bundles, oxidative stress, neuroinflammation and neurotransmitter deficits. Altered glucose and lipid brain metabolism is at its core. Improving brain metabolism can impact these neurodegenerative triggers, including reducing amyloid plaque burden. Current AD drug development is highly focused on plaque reduction, but recently-marketed therapies are not ideal in terms of safety and delivery. The novel mechanism of action, oral once-a-day administration, and safety profile of T3D-959 offers the potential to address the deficiencies of anti-plaque antibodies." About T3D-959: T3D-959, a small molecule, delivered orally once daily, is a brain-penetrating PPAR delta/gamma dual nuclear receptor agonist designed to improve both glucose and lipid metabolism dysfunctions present in AD and other neurodegenerative disorders. About the Study: The Phase 2 PIONEER study (Prospective therapy to Inhibit and Overcome Alzheimer's Disease Neurodegeneration via Brain EnErgetics and Metabolism Restoration) was a double-blind, placebo-controlled, parallel-group Phase 2 safety and efficacy study that enrolled 250 adults with mild-to-moderate Alzheimer's disease (MMSE 14-26). PIONEER was designed to assess the safety, tolerability, and effectiveness of T3D-959 in the treatment of Alzheimer's disease. T3D-959 was administered orally once daily over a 24-week dosing period. Subjects received one of three different doses of T3D-959 (15mg, 30mg, or 45mg) or a placebo. To learn more about this study please visit and reference study number NCT04251182. PIONEER is supported by the National Institute on Aging, part of the National Institutes of Health, under award number R01AG061122 and by the Alzheimer's Association's Part the Cloud Gates Partnership Grant Program. About T3D Therapeutics, Inc.: T3D Therapeutics, Inc. is a privately held, Research Triangle Park, NC-based company. The Company has an exclusive license to T3D-959, its lead product candidate, and a platform of structurally related molecules. T3D Therapeutics' mission is to develop and commercialize T3D-959 for the treatment of Alzheimer's disease. Forward-Looking Statements: Statements contained in this release that are not statements of historical fact are forward-looking statements, including those statements relating to the Company's expectations regarding clinical studies and developments, and the future potential of its product candidates, including T3D-959, and other statements that are predictive in nature or that depend upon or refer to future events or conditions. Without limiting the generality of the foregoing, words such as "may," "will," "expect," "believe," "anticipate," "intend," "could," "estimate" or "continue" are intended to identify forward-looking statements. Readers are cautioned that certain important risks and uncertainties, and assumptions, which if they do not materialize or prove incorrect, may affect the Company's actual results and could cause such results to differ materially from any forward-looking statements which may be made in this release or which are otherwise made by or on behalf of the Company. Factors which may affect the Company's results include, but are not limited to, uncertainties and/or unexpected results related to research and development and clinical testing, the timing, costs and uncertainty of obtaining any required regulatory approvals, changes in the regulatory landscape, uncertainties related to obtaining additional capital as needed to meet the Company's needs on acceptable terms, or at all, the absence of any guarantee of product demand, market acceptance or competitive advantage for any of the Company's product candidates, if approved, and certain trade, legal, social and economic risks. Any forward-looking statement in this release speaks only as of the date on which it is made, and the Company assumes no obligation to update or revise any such forward-looking statement. For more information visit . CONTACT: John Didsbury, Ph.D., CEO T3D Therapeutics, Inc. 1-919-237-4897 Email: info (at) t3dtherapeutics (dot) com SOURCE T3D Therapeutics, Inc.

Gilead Sciences dropped some more long-term data Wednesday bolstering seladelpar's benefit as a potential treatment for primary biliary cholangitis (PBC) ahead of a looming US approval decision in mid-August.New data from the ASSURE trial being presented at the European Association for the Study of the Liver (EASL) congress indicate the oral PPAR-delta agonist, acquired through Gilead's recent $4.3-billion takeout of CymaBay, continued to show rapid and durable improvements across key markers of bile flow impairment."The data presented at EASL further support the sustained efficacy and safety profile of seladelpar observed across its development programme including a capacity to normalise ALP (alkaline phosphatase) values," said Timothy Watkins, head of clinical development for inflammation therapeutics at Gilead. "Seladelpar is a potential best-in-class therapy that could transform the treatment landscape for people living with PBC."The open-label ASSURE study is enrolling up to 500 patients who have already participated in other clinical trials of seladelpar, including the pivotal RESPONSE trial. The two-year interim analysis is based on data from 179 participants as of a January 31 cut-off.Steady improvement on composite goalOut of 99 participants in previous studies who completed 24 months of treatment with seladelpar, the rate of those achieving target goals held steady at 70%. The same was true based on data from 20 patients that Gilead shared last month. The composite response endpoint includes having ALP levels below 1.67 times the upper limit of normal (ULN), reducing ALP levels by ≥15%, and having total bilirubin levels at or below ULN. In addition, 42% of these patients achieved ALP normalisation at 24 months.Looking specifically at the 102 patients who completed the RESPONSE study and then went on to do six more months in ASSURE – for a total of 18 months of continuous seladelpar treatment – 62% achieved the composite response endpoint, and 33% reached normalised ALP levels. Among 29 who took seladelpar continuously for two years, 72% met the composite response endpoint, and 17% achieved normal ALP levels.A subset of ASSURE patients also had compensated liver cirrhosis, and Gilead says they also saw clinically meaningful improvements in markers of cholestasis and liver injury after receiving seladelpar for a second year. Of 32 participants enrolled from legacy studies, 56% met the composite biochemical endpoint at 12 months and 47% saw their ALP levels normalise, without serious adverse events related to treatment.Itch reliefMeanwhile, PBC patients who started with a baseline NRS≥4 level of pruritus continued to feel less itch over time. There was an average 3.8- and 3.1-point decrease in itch at 12 and 24 months, respectively, in participants from legacy studies. For RESPONSE participants, a mean reduction of 3.8 was observed in both continuous and former placebo participants at six months in the ASSURE study."Current medications fall short in about 40% of people. This is because many individuals continue to have abnormal liver tests on the current treatment options, and these treatments don't reduce one of the main relentless symptoms - pruritis," said presenter Palak Trivedi, adding that seladelpar "may meaningfully raise the bar in PBC." For more, see – KOL Views Q&A: Leading expert sizes up PPAR battle between elafibranor, seladelpar in PBC.The FDA is also slated to decide on Ipsen and Genfit's oral PPAR-alpha/delta agonist elafibranor in PBC on June 10. New data presented at EASL from the Phase III ELATIVE trial show 70% of patients treated with elafibranor achieved composite endpoint of slowing disease progression measured by biochemical response after 78 weeks.