A Phase 1, Open-Label, Randomized, Controlled, Four-Period Crossover Study to Assess the Relative Bioavailability of New Oral Formulations of SRT2104 in Healthy Male Volunteers

This is an open-label, randomized, controlled, single center study to assess the safety, variability in exposure, and relative bioavailability of new oral formulations of SRT2104. This is a two part study and each part consists of screening (within 21 days of the first scheduled dose of SRT2104), treatment period and follow-up visit (approximately 6 days after the last dose). Part 1: Subjects will receive all four fomulations of SRT2104 and their order of their doses will be randomized. Each subject will receive one formulation as a 500 milligram (mg) dose (in the form of two 250 mg capsules or tablets) in each session given in the fasted state. Each dose will be separated by at least 6 days. Pharmacokinetic (PK) sampling will be done pre and post each scheduled dosing session. After all 4 dosing sessions, the safety and PK data will be reviewed to determine which, if any, formulation(s) will be carried forward into Part 2. The total duration will be approximately 7 weeks. Part 2: Is further divided into Part 2A, 2B and 2C of the study and are optional. After the completion of Part 1, the sponsor will decide whether to proceed with any or all of Part 2, and whether the selected formulation(s) is to be administered in the fed or fasted state for Parts 2B and 2C. For all the sub parts of Part 2 the pre and post-dose PK samples will be obtained. Part 2A: A single-dose of the selected formulation(s) from Part 1 will be administered after a standard meal to assess the effect of food on the bioavailability of SRT2104 at the 500 mg dose. The total duration will be approximately 4 weeks. Part 2B: A single alternative dose (other than 500 mg, but not to exceed 2000 mg) of the selected formulation(s) from Part 1 will be administered to assess the safety and PK profile of this dose level. The total duration will be approximately 4 weeks. Part 2C: The selected formulation(s) from Part 1 will be administered at the 500 mg dose once daily for 7 consecutive days, to assess the safety and tolerability and characterize the PK profile of repeat dosing. The total duration will be approximately 5 weeks.

Start Date30 Oct 2012

Sponsor / Collaborator

Sirtris Pharmaceuticals, Inc.

NCT01453491 / CompletedPhase 1

A Phase 1b, Exploratory Study to Assess the Safety, Tolerability, Colonic Tissue Exposure, and Anti-Inflammatory Effects of Two Different Doses of SRT2104 in Subjects With Mild to Moderate Ulcerative Colitis

The purpose of this research study is to:
1) Test the safety and tolerability of 2 different oral doses of SRT2104 in subjects with ulcerative colitis
2) Determine the amount of SRT2104 measured from a single blood sample in addition to colon and/or rectal tissue samples (biopsies)
3) Determine whether SRT2104 has any anti-inflammatory effect on the colon and/or rectum when taken orally for 8 weeks
4) Determine whether SRT2104 causes any detectable changes to specific biomarkers. A biomarker is a biological marker (or substance such as a protein) that is used as an indicator of changes in a biological state that corresponds to the risk or progression of a disease.

Start Date13 Feb 2012

Sponsor / Collaborator

Sirtris Pharmaceuticals, Inc.

[+1]

NCT01416376 / CompletedPhase 1

A Double Blind, Placebo Controlled, Phase I Dose-ranging Study to Evaluate the Activity of SRT2379 on Endotoxin Induced Inflammatory Response in Healthy Male Subjects

SRT2379 is a potent small molecule activator of SIRT1 that has been found to inhibit systemic inflammation induced by intravenous injection of lipopolysaccharide (LPS) in mice. The objective of this study is to determine the effect of a single administration of SRT2379, at multiple-dose levels, on the inflammatory response to low dose endotoxin.

Start Date30 Aug 2011

Sponsor / Collaborator

Sirtris Pharmaceuticals, Inc.

[+1]

100 Clinical Results associated with Sirtris Pharmaceuticals, Inc.

0 Patents (Medical) associated with Sirtris Pharmaceuticals, Inc.

Literatures (Medical) associated with Sirtris Pharmaceuticals, Inc.

15 Oct 2020·The Journals of Gerontology: Series AQ1 · MEDICINE

Combining a High Dose of Metformin With the SIRT1 Activator, SRT1720, Reduces Life Span in Aged Mice Fed a High-Fat Diet

Q1 · MEDICINE

Article

Author: Licata, Jordan J ; Mitchell, Sarah J ; de Cabo, Rafael ; Ward, Theresa M ; Minor, Robin K ; Palacios, Hector H ; Abulwerdi, Gelareh ; Elliott, Peter ; Palliyaguru, Dushani L ; Sinclair, David A ; Ellis, James L ; Westphal, Christoph ; Bernier, Michel ; Price, Nathan L

AbstractSRT1720, a sirtuin1-activator, and metformin (MET), an antidiabetic drug, confer health and life-span benefits when administered individually. It is unclear whether combination of the two compounds could lead to additional benefits. Groups of 56-week-old C57BL/6J male mice were fed a high-fat diet (HFD) alone or supplemented with either SRT1720 (2 g/kg food), a high dose of MET (1% wt/wt food), or a combination of both. Animals were monitored for survival, body weight, food consumption, body composition, and rotarod performance. Mice treated with MET alone did not have improved longevity, and life span was dramatically reduced by combination of MET with SRT1720. Although all groups of animals were consuming similar amounts of food, mice on MET or MET + SRT1720 showed a sharp reduction in body weight. SRT1720 + MET mice also had lower percent body fat combined with better performance on the rotarod compared to controls. These data suggest that co-treatment of SRT1720 with MET is detrimental to survival at the doses used and, therefore, risk-benefits of combining life-span-extending drugs especially in older populations needs to be systematically evaluated.

01 Apr 2010·DiabetesQ1 · MEDICINE

SIRT1 mRNA Expression May Be Associated With Energy Expenditure and Insulin Sensitivity

Q1 · MEDICINE

Article

Author: Laakso, Markku ; Sinclair, David A. ; Yamamoto, Hiroyasu ; Rutanen, Jarno ; Itkonen, Paula ; Auwerx, Johan ; Westphal, Christoph ; Lagouge, Marie ; Kainulainen, Sakari ; Pihlajamäki, Jussi ; Vänttinen, Markku ; Elliott, Peter ; Modi, Shalem ; Yaluri, Nagendra

OBJECTIVESirtuin 1 (SIRT1) is implicated in the regulation of mitochondrial function, energy metabolism, and insulin sensitivity in rodents. No studies are available in humans to demonstrate that SIRT1 expression in insulin-sensitive tissues is associated with energy expenditure and insulin sensitivity.RESEARCH DESIGN AND METHODSEnergy expenditure (EE), insulin sensitivity, and SIRT1 mRNA adipose tissue expression (n = 81) were measured by indirect calorimetry, hyperinsulinemic-euglycemic clamp, and quantitative RT-PCR in 247 nondiabetic offspring of type 2 diabetic patients.RESULTSHigh EE during the clamp (r = 0.375, P = 2.8 × 10−9) and high ΔEE (EE during the clamp − EE in the fasting state) (r = 0.602, P = 2.5 × 10−24) were associated with high insulin sensitivity. Adipose tissue SIRT1 mRNA expression was significantly associated with EE (r = 0.289, P = 0.010) and with insulin sensitivity (r = 0.334, P = 0.002) during hyperinsulinemic-euglycemic clamp. Furthermore, SIRT1 mRNA expression correlated significantly with the expression of several genes regulating mitochondrial function and energy metabolism (e.g., peroxisome proliferator–activated receptor γ coactivator-1β, estrogen-related receptor α, nuclear respiratory factor-1, and mitochondrial transcription factor A), and with several genes of the respiratory chain (e.g., including NADH dehydrogenase [ubiquinone] 1α subcomplex 2, cytochrome c, cytochrome c oxidase subunit IV, and ATP synthase).CONCLUSIONSImpaired stimulation of EE by insulin and low SIRT1 expression in insulin-sensitive tissues is likely to reflect impaired regulation of mitochondrial function associated with insulin resistance in humans.

01 Apr 2008·Current opinion in investigational drugs (London, England : 2000)

Sirtuins: novel targets for metabolic disease.

Review

Author: Elliott, Peter J ; Jirousek, Michael

Sirtuins represent a novel family of enzymes that are collectively well situated to help regulate nutrient sensing and utilization, metabolic rate and ultimately metabolic disease. Activation of one of these enzymes, SIRT1, leads to enhanced activity of multiple proteins, including peroxisome-proliferator activated receptor coactivator-1alpha (PGC-1alpha), which helps to mediate some of the in vitro and in vivo effects of sirtuins. As such, enhanced SIRT1 activity decreases glucose levels, improves insulin sensitivity, increases mitochondrial number and function, decreases adiposity, improves exercise tolerance and potentially lowers body weight. SRT-501 is a proprietary formulation of resveratrol with improved bioavailability. As such, SRT-501 represents the first in a novel class of SIRT1 activators that has proven to be safe and well-tolerated in humans. Clinical trials in type 2 diabetic patients are currently underway.

News (Medical) associated with Sirtris Pharmaceuticals, Inc.

22 Aug 2024

·www.fiercebiotech.com

Ex-GSK CEO takes up board post at aging and obesity biotech BioAge

BioAge put itself on the map in 2020 by raising $90 million to treat aging and age-related diseases. BioAge Labs has appointed former GSK CEO Jean-Pierre Garnier as chair of its board of directors, bringing the pharma veteran back into the anti-aging space 16 years after he made a big bet on the sector.Garnier worked as CEO of GSK, then called GlaxoSmithKline, from 2000 to 2008. Toward the end of his time heading up the company, Garnier oversaw the $720 million acquisition of Sirtris Pharmaceuticals. The biotech landed the buyout on the basis of evidence that resveratrol, a molecule in red wine, and other sirtuin-targeted drugs could extend healthy life spans.Sirtris ran into problems in the years after the buyout, with programs failing and researchers at Amgen and Pfizer questioning the validity of the science underpinning the biotech. GSK shuttered Sirtris in 2013. Garnier worked as CEO of Pierre Fabre for two years after departing GSK. Since leaving the CEO life behind, Garnier has held a series of board positions at biotechs including Actelion, Cellectis and Idorsia. BioAge sees benefits to being the latest biotech to bring Garnier onto its board. “His extensive experience in leading biotech and pharmaceutical companies through critical growth phases will be invaluable as we progress our lead compound, azelaprag, through clinical development for obesity and advance our pipeline of metabolic aging therapies,” BioAge CEO Kristen Fortney, Ph.D., said in a statement.BioAge put itself on the map in 2020 by raising $90 million to treat aging and age-related diseases. This year, BioAge raised a further $170 million to capitalize on the potential for its apelin receptor agonist azelaprag to combine well with GLP-1 drugs, boosting weight loss while preserving muscle mass. BioAge picked up the asset from Amgen.Garnier's reemergence on the anti-aging scene comes about two years after Hal Barron, M.D., stepped down as chief scientific officer of GSK to take the CEO post at another biotech with a longevity angle, Altos Labs.

Executive ChangeAcquisition

01 Aug 2023

·www.biospace.com

Solu Therapeutics Debuts with $31 Million in Seed Funding to Unlock Antibody-Intractable Cell Surface Targets

Clinical candidate selected, initially targeting hematological malignancies BOSTON--(BUSINESS WIRE)-- Solu Therapeutics, a precision-medicine company developing therapeutics to eliminate disease-driving cells, founded by Longwood Fund, today announced the closing of an oversubscribed $31 million seed financing co-led by Longwood and Santé Ventures, with additional participation from DCVC Bio, Astellas Venture Management, and Alexandria Venture Investments. The proceeds will be used to leverage and develop the proprietary CyTaC (Cytotoxicity Targeting Chimera) platform and drug candidates which were in-licensed from GSK by the Company. This platform is designed to unlock antibody-intractable cell surface targets and build next-generation medicines that harness the power of biologics with the vast target binding space of small molecules. “We are using the CyTaC platform to develop bifunctional small molecules with one arm binding the extracellular target and the other arm binding a proprietary antibody that can recruit the immune system to kill cancer and other pathogenic cells,” commented David Donabedian, Ph.D., co-founder and start-up CEO. “The innovative platform and drug candidates were licensed from GSK and have potential applications across multiple therapeutic areas, including oncology, immunology, and autoimmunity. With the capital from this financing, we plan to advance our lead program in oncology into the clinic within two years and advance several of our other product candidates through pre-clinical development.” As part of the financing, Christoph Westphal, M.D., Ph.D., Founding Executive Chairman, Solu Therapeutics, and Founding Partner, Longwood Fund; Omar Khalil, Partner, Santé Ventures; John Hamer, Ph.D., Managing Director, DCVC Bio; Satoshi Konagai, Astellas Venture Management; and Peter Hutt have joined Solu Therapeutics’ Board of Directors. In return for the license, GSK received equity in Solu and will receive milestones and royalties on products derived from the CyTaC platform. “Antibody therapeutics have had tremendous success across multiple disease areas, however, there is still tremendous untapped potential,” commented Dr. Westphal. “We believe that the novel technology and world-class team recruited to build out Solu Therapeutics will unlock this potential to create a new generation of precision medicines.” “I believe the CyTaC platform opens a vast array of opportunities by combining the pharmacology and efficacy of antibodies with the binding capacity and dose control of small molecules,” commented Mr. Khalil. “We’re excited to partner with the Solu team as they develop new medicines for patients who otherwise have limited therapeutic options.” About Solu Therapeutics Solu Therapeutics, a precision-medicine company, is developing therapeutics to eliminate disease-driving cells in cancer, immunology, and autoimmunity. The proprietary CyTaC (Cytotoxicity Targeting Chimera) platform and drug candidates, licensed from GSK, unlocks antibody-intractable cell surface targets providing the capability to develop next generation medicines that harness the power of biologics with the vast target binding space of small molecules. Unique characteristics of CyTaC platform molecules include: (i) unlocking new tumor-associated antigens to eliminate cancer cells, (ii) depleting pathogenic immune cells, and (iii) extending the half-life of small molecule antagonists and agonists. About Longwood Fund Longwood Fund is a venture capital firm dedicated to creating and investing in novel healthcare companies that develop important treatments to help patients while generating significant value for investors. The Longwood team has a long history of successfully launching and building important life science companies while providing operational leadership and strategic guidance. Collectively, the Partners at Longwood Fund have co-founded 25 companies with over 20 launched or marketed drugs and therapies, as well as over two dozen clinical stage assets, all focused on helping patients in need. Companies founded by Longwood Fund, or its principals prior to the founding of the Firm, as lead investor and CEO/CBO include Acceleron, Momenta, Alnylam, Vertex, Sirtris, Vor, TScan, Pyxis Oncology, Immunitas, Be Biopharma, Tome Biosciences, Photys, Carbon Biosciences, and DEM BioPharma. For more information, please visit . About Santé Ventures Founded in 2006, Santé Ventures is a specialized healthcare and life sciences investment firm with nearly $800M in capital under management. The firm invests in early-stage companies developing innovative new medical technologies, biotechnologies, and digitally enabled healthcare services. Recent Santé successes include Farapulse (Boston Scientific), Claret Medical (Boston Scientific), TVA Medical (Becton Dickinson), Millipede Medical (Boston Scientific), Molecular Templates (MTEM), AbVitro (Celgene), and Explorys (IBM Corp). Santé invests nationally and has offices in Austin, TX, and Boston, MA. For more information, please visit . About DCVC Bio DCVC is deep tech venture capital. It always has been. Over more than a dozen years, DCVC has backed brilliant entrepreneurs using computational approaches to solve trillion-dollar problems in the real world across a broad set of industries, especially those that haven’t seen material progress in decades. With billions of dollars of assets under management, DCVC builds long-term relationships with the founders they back. The firm has been with many of its companies from their very start — and through to their recognition by the public markets as category-defining businesses. For more information, please visit .

License out/in

06 Jun 2023

·www.globenewswire.com

AAVantgarde Closes €61 Million Series A Financing to Advance Two Therapeutic Programs into the Clinic

- Financing led by Atlas Venture and Forbion - Company created, incubated and seed financed by Sofinnova Partners MILAN, Italy, June 06, 2023 (GLOBE NEWSWIRE) -- AAVantgarde Bio (AAVantgarde), a clinical-stage, Italian-based international biotechnology company with two proprietary Adeno-Associated Viral (AAV) vector platforms for large gene delivery, today announced the closing of a €61 million Series A financing. The financing was co-led by US biotechnology venture creation firm Atlas Venture and European life sciences venture capital investment firm Forbion, with participation from Longwood Fund and the Company’s founding investor Sofinnova Partners through its Sofinnova Telethon Fund. In connection with the Series A financing Jason Rhodes from Atlas Venture, Dmitrij Hristodorov from Forbion, and David Steinberg from Longwood Fund will join the AAVantgarde Board. AAVantgarde has two proprietary, AAV-based large gene delivery platforms: one leveraging DNA recombination, named dual hybrid; and one protein trans-splicing, named AAV intein. The company is validating the platforms in two lead programs: Usher Syndrome Type 1 B associated retinitis pigmentosa (Usher1B), using dual hybrid; and Stargardt disease, using AAV intein. This financing will fund completion of a first-in-man proof of concept (POC) study in subjects with Usher1B and further development of AAV intein program and entry into the clinic for Stargardt disease. The company also intends to pursue programs beyond ophthalmology. “This financing represents a hallmark moment in our mission to help patients and we are excited to work with both our new and founding investors to advance our platforms and pipeline,” said Dr. Natalia Misciattelli, Chief Executive Officer of AAVantgarde. “The completion of this round with such a high-caliber group of global life science investors is a recognition of the significance of AAVantgarde’s unique technology, which will initially be utilized to help patients suffering with the debilitating impact of blindness associated with Usher1B syndrome and Stargardt disease.” “AAV gene therapy has been limited by transgene capacity, and AAVantgarde’s proprietary platforms enable delivery of large genes to tissue and cells in vivo; something that could extend into many disease areas,” said Jason Rhodes, partner at Atlas Venture. “AAVantgarde has a clear mission to bring next generation genetic medicines to underserved patients with debilitating diseases, bringing hope to inherited retinal disease patients with Usher1B syndrome and Stargardt disease to improve vision,” said Dmitrij Hristodorov of Forbion. “We are excited by the opportunity to partner with, and support, such a dedicated team with a proven track record of success.” About AAVantgarde BioAAVantgarde Bio is a clinical stage, Italian headquartered, international biotechnology company that has developed two proprietary Adeno-Associated Viral (AAV) vector platforms to address the gene therapy cargo capacity limitations of AAV vectors. The AAVantgarde platforms could be used to deliver large genes to ocular and non-ocular tissues. Co-founded by Professor Alberto Auricchio at TIGEM (Telethon Institute of Genetics and Medicine) in Naples, Italy, and Telethon Foundation, AAVantgarde will initially validate the platform in the clinic in two inherited retinal diseases with clear unmet need. For more information, please visit: www.aavantgardebio.com About Atlas VentureAtlas Venture is a leading biotech venture capital firm. With the goal of doing well by doing good, we have been building breakthrough biotech startups for over 25 years. We work side by side with exceptional scientists and entrepreneurs to translate high impact science into medicines for patients. Our seed-led venture creation strategy rigorously selects and focuses investment on the most compelling opportunities to build scalable businesses and realize value. For more information, please visit www.atlasventure.com About Forbion Forbion is a dedicated life sciences venture capital firm with offices in The Netherlands, Germany and Singapore. Forbion invests in life sciences companies that are active in the (bio-) pharmaceutical space. Forbion manages €3 billion across multiple fund strategies that cover all stages of (bio-) pharmaceutical drug development. Forbion’s current team consists of over 30 life sciences investment professionals that have built an impressive performance track record since the late nineties with investments in 95 companies across 8 funds. Forbion’s record of sourcing, building and guiding life sciences companies has resulted in many breakthrough therapies and valuable exits. Portfolio company successes include NewAmsterdam Pharma, Gyroscope (acquired by Novartis) and Replimune. Besides financial objectives, Forbion selects investments that will positively affect the health and well-being of patients. The firm is a signatory to the United Nations Principles for Responsible Investment. Forbion operates a joint venture with BGV, the manager of seed and early-stage funds, especially focused on Benelux and Germany. For more information, please visit: www.forbion.com About Sofinnova Partners Sofinnova Partners is a leading European venture capital firm in life sciences, specializing in healthcare and sustainability. Based in Paris, London and Milan, the firm brings together a team of professionals from all over the world with strong scientific, medical and business expertise. Sofinnova Partners is a hands-on company builder across the entire value chain of life sciences investments, from seed to later-stage. The firm actively partners with ambitious entrepreneurs as a lead or cornerstone investor to develop transformative innovations that have the potential to positively impact our collective future. Founded in 1972, Sofinnova Partners is a deeply established venture capital firm in Europe, with 50 years of experience backing over 500 companies and creating market leaders around the globe. Today, Sofinnova Partners has over €2.5 billion under management. For more information, please visit: www.sofinnovapartners.com About Longwood FundLongwood Fund is a venture capital firm dedicated to creating and investing in novel healthcare companies that develop important treatments to help patients while generating significant value for investors. The Longwood team has a long history of successfully launching and building important life science companies while providing operational leadership and strategic guidance. Collectively, the Partners at Longwood Fund have co-founded 24 companies with over 20 launched or marketed drugs and therapies, as well as over two dozen clinical stage assets, all focused on helping patients in need. Companies founded by Longwood Fund, or its principals prior to the founding of the Firm, as lead investor and CEO/CBO include Acceleron, Momenta, Alnylam, Vertex, Sirtris, Vor, TScan, Pyxis Oncology, Immunitas, Be Biopharma, Tome Bio, Photys, Carbon Biosciences, and DEM BioPharma. For more information, please visit www.longwoodfund.com. About Fondazione Telethon and TIGEMFondazione Telethon (the Telethon Foundation) is a major biomedical charity in Italy whose mission is to advance biomedical research to cure rare genetic diseases. Throughout its 32 years of activity, Fondazione Telethon has invested almost €600 million in funding over 2,700 projects to study 580 diseases, involving more than 1,600 researchers in Italy. As part of its goal to foster development and maximize the therapeutic impact of research, Fondazione Telethon further pursues cooperation with academia, industry, and venture capital through the creation of partnerships and start-ups. TIGEM is a Telethon Foundation research centre in Pozzuoli, near Naples, and comprises several research groups and over 200 staff members, all dedicated to understanding the molecular mechanisms behind rare genetic diseases and developing novel treatments. For more information, please visit www.telethon.it/en About Usher syndromeUsher syndrome type 1B (Usher1B) is an inherited disease that affects the retina and the inner ear. Usher1B is caused by mutations in the MYO7A gene. The therapeutic gene to treat Usher1B is 6.7 kb long and is therefore too large to fit inside a standard AAV vector. Approximately 20,000 patients in the U.S. and E.U. have Usher1B. These children are born deaf, have vestibular dysfunction, and begin to progressively lose vision in their first decade of life. Although, there are surgical treatments available to treat deafness in these patients, there are no treatments available to treat progressive vision loss and blindness in these patients. About Stargardt DiseaseStargardt disease is the most common inherited macular degeneration. Inherited in most of the cases as autosomal recessive, Stargardt disease is caused by mutations in the ABCA4 gene. The therapeutic gene to treat Stargardt disease (ABCA4) is 6.8 kb long which is too large to fit inside a standard AAV vector. Stargardt disease affects approximately 60,000-75,000 patients in the U.S. and E.U. Currently there are no treatments for the blindness caused by Stargardt disease. Contact:Julia Wilson - JW CommunicationsPhone: +44 (0) 7818 430877Email: juliawilsonuk@gmail.com

Gene Therapy

100 Deals associated with Sirtris Pharmaceuticals, Inc.

100 Translational Medicine associated with Sirtris Pharmaceuticals, Inc.

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

SRT1460 ( SIRT1 )	Diabetes Mellitus, Type 2 More	Preclinical
Bortezomib ( Proteasome )	Multiple Myeloma More	Discontinued
Resveratrol ( SIRT1 )	Multiple Myeloma More	Discontinued
SRT-3025 ( SIRT1 )	Diabetes Mellitus, Type 2 More	Pending
SRT-2104 ( SIRT1 )	Psoriasis More	Pending

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