Phase II, Randomized, Double-masked, Active-controlled Study of Fixed-Dose Combinations of Trabodenoson and Latanoprost in Subjects With Ocular Hypertension or Primary Open-Angle Glaucoma

Phase II, randomized, double-masked study to evaluate the efficacy and tolerability of topical ocular delivery of fixed-dosed combinations of trabodenoson and latanoprost in subjects with Ocular Hypertension or Primary Open-Angle Glaucoma.
All subjects who meet the study's enrollment criteria following Screening will undergo washout of all prohibited medications (if washout is needed), including their routine glaucoma medications. During the Placebo Run-In Period, placebo is applied twice daily to both eyes in all subjects. During the Treatment Period, study drug is applied to both eyes for a total of 8 weeks. Each subject will be assigned 4 weeks of AM and 4 weeks of PM dosing in a masked manner. AM vs PM dosing is masked utilizing Placebo in addition to the active drug product. During the Treatment Period, study drug (Active and Placebo) eye drop applications will occur twice daily, in the morning and in the evening. The Treatment Period will be followed by an Observation Period of approximately 7 days wherein no study eye drops are instilled.
The purpose of the study is to assess the overall benefit/risk profile of binocular topical application of different doses of trabodenoson (3.0% and 6.0%) when combined with latanoprost (0.005% or 0.0025%) one drop daily (QD) for 8 weeks.

开始日期2016-08-19

申办/合作机构

Inotek Pharmaceuticals Corp.

NCT02565173 / Completed临床3期

Phase III Multi-center, Randomized, Double-masked, Active- and Placebo-controlled Study of Trabodenoson in Adults With Ocular Hypertension or Primary Open-angle Glaucoma

Phase III trial involving topical application, in both eyes, of trabodenoson ophthalmic formulation 3.0% or 6.0% once per day or 4.5% twice per day, placebo twice per day, or timolol 0.5% twice per day for 12 weeks in adult subjects with Ocular Hypertension or Primary Open-Angle Glaucoma.
All subjects who meet the study's enrollment criteria following Screening will undergo washout of all prohibited medications, including their routine glaucoma medications. During the Placebo Run-In Period, placebo is administered twice daily to both eyes in all subjects. During the Treatment Period, study drug is applied to both eyes for a total of 12 weeks followed by an Observation Period of approximately 7 days wherein no study eye drops are instilled.
The purpose of the study is to assess the efficacy, tolerability, and safety of binocular topical application of trabodenoson ophthalmic formulation 3.0% or 6.0% QD or 4.5% BID for 12 weeks.
Timolol is being included in the trial in order to have an active control to ensure the integrity of the trial from an efficacy perspective; the primary comparator for all statistical purposes is the placebo arm.

开始日期2015-09-01

申办/合作机构

Inotek Pharmaceuticals Corp.

NCT01917383 / Completed临床2期

A Phase II Multi-center, Randomized Study to Evaluate the Monocular Addition of Trabodenoson (INO-8875) Ophthalmic Formulation to Latanoprost Ophthalmic Solution Therapy in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma

The purpose of this study is to evaluate the intraocular pressure (IOP) lowering efficacy and the safety and tolerability profile of trabodenoson ophthalmic formulation compared to timolol maleate ophthalmic solution 0.5% in adults with ocular hypertension (OHT) or primary open-angle glaucoma (POAG) who are already receiving treatment with latanoprost ophthalmic solution 0.005% once every evening (QPM).

开始日期2013-08-01

申办/合作机构

Inotek Pharmaceuticals Corp.

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2018-06-19·Investigative ophthalmology & visual science2区 · 医学

Efficacy of Trabodenoson in a Mouse Keratoconjunctivitis Sicca (KCS) Model for Dry-Eye Syndrome

2区 · 医学

ArticleOA

作者: Hakkarainen, Jenni J. ; Kaja, Simon ; Kalesnykas, Giedrius ; Albers, David S. ; Ragauskas, Symantas ; Baumgartner, Rudolf ; Rich, Cadmus C. ; Žiniauskaite, Agne

Purpose:

To determine the efficacy of trabodenoson, an adenosine mimetic with highly selective adenosine A1 receptor binding properties, in a preclinical mouse model for dry-eye disease.

Methods:

Dry-eye disease was induced in adult male C57BL/6 mice using a combination of desiccating environment and transdermal administration of scopolamine. Mice were treated concurrently and twice daily with either vehicle, 6% trabodenoson, or 0.05% cyclosporine (Restasis). Efficacy (P < 0.05 versus vehicle) was determined by clinical assessment of dry-eye symptoms using corneal fluorescein staining and tear volumes and histopathologically by quantifying lacrimal gland pathology and conjunctival goblet cells.

Results:

Twice-daily topical (ocular) administration of trabodenoson increased tear levels and reduced corneal fluorescein staining (P < 0.05) as compared with vehicle-treated eyes in a mouse model of dry-eye disease. Furthermore, significant infiltration of immune cells in the lacrimal gland and reduced number of mucin-producing conjunctival goblet cells were noted in both untreated and vehicle-treated eyes. Comparatively, trabodenoson treatment significantly reduced lacrimal gland infiltration and increased the number of goblet cells (P < 0.05 for both versus vehicle). These trabodenoson-related effects on lacrimal gland pathology and goblet cells were similar to or better than the effects observed with cyclosporine treatment.

Conclusions:

Topical ocular delivery of trabodenoson significantly improves the clinical and histopathological signs associated with dry-eye disease in mice. This improvement appears to be related to anti-inflammatory effects from targeting adenosine signaling and represents a novel therapeutic approach to develop for the management of dry-eye disease.

2018-01-18·Investigative ophthalmology & visual science2区 · 医学

Trabodenoson, an Adenosine Mimetic With A₁ Receptor Selectivity Lowers Intraocular Pressure by Increasing Conventional Outflow Facility in Mice

2区 · 医学

ArticleOA

作者: Unser, Andrea M. ; Li, Guorong ; Albers, David S. ; Ahmed, Feryan ; Baumgartner, Rudolf A. ; Torrejon, Karen Y. ; Navarro, Iris D. ; Stamer, W. Daniel

Purpose:

To evaluate the relationship between the IOP-lowering effect of trabodenoson and the associated structural and functional changes in the trabecular meshwork (TM).

Methods:

Six independent cohorts of young and aged mice were exposed to three different topical once-a-day formulations of trabodenoson and eyes were compared to those treated with placebo drops. IOP was measured daily just before drug administration using rebound tonometry. Outflow facility was measured in enucleated eyes. Flow patterns and morphology of conventional outflow tissues were monitored using tracer beads and standard histology, respectively. In parallel, three-dimensional human TM tissue constructs (3D-HTM) were grown and used in experiments to test effect of trabodenoson on the expression of collagen IV, fibronectin, matrix metalloproteinase (MMP)-2 and MMP-14 plus MMP-2 activity.

Results:

Topical administration of trabodenoson significantly lowered IOP on every day tested, up to 7 days. After 2 days of treatment, outflow facility increased by 26% in aged mice and 30% overall (young and aged mice), which was significantly different from vehicle (P < 0.05). Outflow facility was 15% higher than controls after 7 days of treatment (P = 0.07). While gross morphology was not affected by treatment, the intensity of tracer bead distribution increased by day 7 (P = 0.05). Parallel experiments in 3D-HTM showed that trabodenoson treatment significantly increased MMP-2 activity and MMP-14 abundance, while decreasing fibronectin and collagen IV expression.

Conclusions:

Trabodenoson alters ECM turnover by TM cells and increases conventional outflow facility, which accounts for its ability to lower IOP in young and aged mice.

2016-10-01·Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics4区 · 医学

A Randomized Phase 1 Dose Escalation Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Trabodenoson in Healthy Adult Volunteers

4区 · 医学

Article

作者: McVicar, William ; Brickman, Chaim ; Rich, Cadmus C. ; Baumgartner, Rudolf A. ; Stoltz, Randall ; Laties, Alan ; Humbert, Vernon

PURPOSE:

To investigate the safety, tolerability, and pharmacokinetics of trabodenoson, a highly selective adenosine mimetic targeting the adenosine A₁ receptor.

METHODS:

In Part 1, 60 healthy adult volunteers were randomized to 14 days of twice-daily topical monocular application of placebo or trabodenoson (200, 400, 800, 1,600, 2,400, or 3,200 μg). In Part 2, 10 subjects were randomized to placebo or 8 escalating doses of bilateral trabodenoson (total daily doses: 1,800-6,400 μg).

RESULTS:

The incidence of treatment-related adverse events in Part 1 was similar in the trabodenoson (27.8%) and placebo (25.0%) groups. Most were mild in intensity. The most common adverse events (AEs) for trabodenoson and placebo were headache (25.0% vs. 33%, respectively) and eye pain (11.1% vs. 4.2%, respectively). Ocular AEs were infrequent (16.7% and 17.9%, respectively), were self-limited, lasted <24 h, and were typically mild in intensity. The most common ocular AE was eye pain (9.5% and 3.6%, respectively), with a single observation of ocular hyperemia (200 μg trabodenoson). Trabodenoson was rapidly absorbed [median time to maximum concentration (t_max): ∼0.08 to 0.27 h] and eliminated (t_½: 0.48-2.0 h), with no evidence of drug accumulation. Systemic exposure to topical trabodenoson was dose related but not dose proportional, with a plateau effect at doses ≥2,400 mg per eye. No clinically significant treatment-related systemic AEs were observed, and increasing systemic exposure had no effect on heart rate or blood pressure.

CONCLUSIONS:

Ocular doses of trabodenoson up to 3,200 μg per eye were safe and well tolerated in the eye and resulted in no detectable systemic effects in healthy adult volunteers.

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2024-07-09

·BioSpace

ReAlta Life Sciences Strengthens Board of Directors with Appointment of Accomplished Financial Executive

New appointment brings global financial and operational experience in life sciences to support continued advancement of ReAlta’s EPICC Technology Platform NORFOLK, Va.--(BUSINESS WIRE)-- ReAlta Life Sciences, Inc. (“ReAlta” or the “Company”), a mid-stage clinical biotech company dedicated to saving lives by rebalancing the inflammatory response to address life-threatening diseases, today announced the appointment of Emma Reeve to its Board of Directors, effective immediately. “We are very pleased to welcome Emma Reeve to our Board of Directors,” said Buzz Heidt, Chairman of ReAlta’s Board of Directors. "As ReAlta continues to advance our programs towards commercial launch in markets around the world, Emma's diverse global experience and deep knowledge of capital markets and financial strategies will help guide and strengthen our plans to deliver novel therapies to the patients that urgently need them.” “I am impressed with the remarkable progress ReAlta has made to advance multiple programs into the clinic,” said Ms. Reeve. “I am excited to take on this role and contribute to the company’s mission to address life threatening acute inflammatory and rare diseases.” Emma Reeve Emma Reeve is an accomplished biopharmaceutical executive with more than 30 years of global financial experience across pharmaceutical, medical device, and bio-pharma companies. Most recently, Ms. Reeve served as Chief Financial Officer of Constellation Pharmaceuticals, Inc., a development-stage oncology company, prior to its acquisition by MorphoSys AG in 2021. She led Constellation’s IPO in 2018. Prior to Constellation, Ms. Reeve acted as interim Chief Financial Officer and Corporate Controller of Parexel International, a global biopharmaceutical services company, where she was responsible for all aspects of finance, investor relations, procurement, and facilities. In this role, she led the finance aspects of a sell-side process which culminated in an agreement to take the company private in a $5 billion leveraged buy-out. Earlier in her career, Ms. Reeve served as Chief Financial Officer of both Inotek Pharmaceuticals and Aton Pharma. Additionally, she held senior finance and operational roles at Bristol Myers Squibb, Merck, and Novartis. Ms. Reeve is currently Chair of the Board of Editas Medicine and serves on the Board of PTC Therapeutics and Aadi Bioscience, all public biotechnology companies. In addition, she serves on the Board of Directors for Cardurion Pharma. Ms. Reeve holds a B.Sc. in computer science from Imperial College, University of London and is an associate of the Institute of Chartered Accountants in England and Wales. About ReAlta Life Sciences ReAlta Life Sciences, Inc. is a mid-stage clinical biotech company dedicated to saving lives by rebalancing the inflammatory response to address life threatening acute inflammatory and rare diseases. The Company’s EPICC peptides are based on research into the human astrovirus, HAstV-1, which causes a non-inflammatory, self-limiting gastroenteritis unique among viruses by inhibiting components of the innate immune system. ReAlta’s therapeutic peptides leverage these virus-derived mechanisms to rebalance complement and inflammatory processes in the body. The company’s pipeline is led by RLS-0071, which has received IND clearance by the U.S. Food and Drug Administration (FDA) for the treatment of acute exacerbations of chronic obstructive pulmonary disease and acute graft-versus-host disease, and IND clearance, Orphan Drug Designation, and Fast Track Designation by the FDA, and Orphan Drug Designation by the European Medicines Agency, for the treatment of hypoxic-ischemic encephalopathy (HIE). The company launched in 2018 and is located in Norfolk, Virginia. For more information, please visit . View source version on businesswire.com: Contacts Media and Investor Contact: John Rickman Chief Financial Officer jrickman@realtals.com Source: ReAlta Life Sciences View this news release online at:

高管变更孤儿药快速通道IPO

2023-10-04

·BioSpace

Cardurion Pharmaceuticals Welcomes Emma Reeve as Independent Board Director and Audit Chair

Accomplished CFO and Board Leader to Provide Independent Leadership to Deliver on Company’s Growth Strategy BURLINGTON, Mass.--(BUSINESS WIRE)-- Cardurion Pharmaceuticals, Inc. (“Cardurion” or “the Company”), a clinical-stage biotechnology company focused on the discovery and development of novel, next-generation therapeutics for the treatment of cardiovascular diseases, today announced the appointment of Emma Reeve as an independent board director and audit chair. Ms. Reeve brings to Cardurion more than 25 years of global financial leadership and board experience across pharmaceutical, medical device and biopharma companies. Most recently, Ms. Reeve served as Chief Financial Officer of Constellation Pharmaceuticals, Inc., a development-stage oncology company, where she led a 2018 public offering and oversaw the company’s 2021 sale to MorphoSys AG for $1.7 billion. Prior to Constellation, she acted as interim Chief Financial Officer of Parexel International, a global biopharmaceutical services company, where she was responsible for all aspects of finance and investor relations and helped lead a $5 billion take private transaction by Pamplona Capital Management. Earlier in her career, she served as Chief Financial Officer of both Inotek Pharmaceuticals and Aton Pharma and held senior finance roles in major pharmaceutical companies, including Novartis, Merck and Bristol Myers Squibb. “We are fortunate to welcome a leader of Emma’s experience and caliber to our Board at this exciting inflection point in Cardurion’s growth journey. As a seasoned life sciences executive with deep expertise in finance, capital markets and corporate strategy, Emma brings tremendous perspective to Cardurion’s Board,” said Michael E. Mendelsohn, M.D., Founder and Chairman of Cardurion. “We look forward to collaborating with Emma as Cardurion advances our two groundbreaking clinical programs in PDE9 and CaMKII inhibition and continues to address other unmet needs for patients with cardiovascular disease.” Ms. Reeve currently serves as board chair at Editas Medicine, and as a board director at PTC Therapeutics, Aadi Bioscience and Ribon Therapeutics. She is also a member of the board of Trustees of Tufts Medical Center. Ms. Reeve holds a B.Sc. in computer science from Imperial College, University of London, and is an associate of the Institute of Chartered Accountants in England & Wales. “I am impressed with the bold and innovative approach Cardurion is taking to help patients suffering from and at risk for cardiovascular disease,” said Ms. Reeve. “I am excited to contribute to the Company’s mission to advance novel cardiovascular drug candidates while building on its strong foundation and industry-leading expertise.” About Cardurion Pharmaceuticals Cardurion is a clinical-stage biotechnology company focused on the discovery and development of novel, next-generation therapeutics for the treatment of cardiovascular diseases. Cardurion was founded by physician-scientists with world-class expertise in cardiovascular signaling pathways, and a shared passion to find and develop a pipeline of novel treatment options to improve the lives of patients. Cardurion has two groundbreaking clinical programs in development, a PDE9 program targeting heart failure and the first ever CaMKII inhibitor in clinical development targeting multiple cardiovascular indications. Cardurion Pharmaceuticals has facilities in Burlington, Massachusetts and Shonan, Japan. For more information, please visit the company’s website at .

高管变更IPO

2023-09-12

·GlobeNewswire-Health Care

Sensorium Therapeutics Appoints Veteran Life Sciences Executive Mr. David Southwell to its Board of Directors

BOSTON, Sept. 12, 2023 (GLOBE NEWSWIRE) -- Sensorium Therapeutics (Sensorium), a biotechnology company translating insights from nature and human experience to deliver transformational therapeutics, today announced the appointment of veteran life sciences executive David Southwell to its Board of Directors. “We are excited to welcome David to our Board,” said Dick Simon, Chief Executive Officer of Sensorium. “He is a seasoned life sciences executive with a track record of success that spans multiple therapeutic areas and development stages. David’s depth of experience will be a key asset as we advance our lead program, SENS-01, towards the clinic and expand our drug pipeline into additional high value indications.” David Southwell is a biotechnology leader, exemplified by his most recent role as Chief Executive Officer of TScan Therapeutics, Inc. (NASDAQ:TCRX), a clinical-stage immuno-oncology company focused on T cell receptors. Previously, he served as Chief Executive Officer of Inotek Pharmaceuticals (NASDAQ:ITEK), a clinical-stage ophthalmology company, which merged into Rocket Pharmaceuticals, a clinical-stage gene therapy company, in 2018. David served as Executive Vice President and Chief Financial Officer of Human Genome Sciences from 2010 until the acquisition by GSK in 2012, and was previously on the board of HGSI from 2008-2010. Prior to joining Human Genome Sciences, he served as Executive Vice President and Chief Financial Officer of Sepracor, Inc., a pharmaceutical company, from June 1994 to March 2008. From August 1988 until 1994, Mr. Southwell worked in investment banking at Lehman Brothers Inc. “As someone who has spent decades in this field, I am excited to join the Board of Sensorium,” stated Mr. Southwell. “I believe the Company’s approach to drug discovery, which is target-agnostic and based on a documented history of human use, can yield new mechanistic treatment approaches that are both more efficacious and better tolerated than current standards of care. The CNS field, in particular, represents tremendous unmet need with standards of care developed decades ago.” In addition to Sensorium, Mr. Southwell currently serves on the Boards of Rocket Pharmaceuticals and PTC Therapeutics (NASDAQ:PTCT), and previously served on the Boards of Spero Therapeutics (NASDAQ:SPRO), THL Credit, and Inventiv Health, as well as Chairman of Biosphere Medical. David earned a B.A. in economics and managerial studies from Rice University and an M.B.A. from the Tuck School of Business at Dartmouth College. About Sensorium Therapeutics Sensorium Therapeutics is a biotechnology company translating insights from nature and human experience to deliver safer, more efficacious therapeutics, leading with unmet needs in the CNS space. Sensorium’s novel discovery platform leverages the largest proprietary database of natural products with demonstrated human efficacy, and high throughput iPSC neuronal screening powered by an iterative AI data engine. This target agnostic approach enriches for unique mechanisms of action and rapidly identify leads that are phenotypically superior to current standards of care, potentially increasing the probability of clinical success. Sensorium’s lead program, SENS-01, is being developed as a next-generation therapeutic to treat depression and anxiety. Founded by world-class researchers, clinicians, and drug developers from Massachusetts General Hospital and Harvard Medical School, the company completed a $31M Series A financing in late 2022 led by Santé Ventures, with participation from Route 66 Ventures, CU Healthcare Innovation Fund, and others. Visit sensorium.bio to learn more. Contact:John MullalyLifeSci Advisors, LLCjmullaly@lifesciadvisors.com

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