A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Pharmacokinetics of 3 Doses of INV-202 With an Optional Open-Label Extension in Patients With Obesity and Metabolic Syndrome

The study is designed to assess the efficacy, safety, tolerability, and transformation within the human body of INV-202 investigational drug in the treatment of adult participants with obesity and metabolic syndrome.

Start Date08 Sep 2023

Sponsor / Collaborator

Inversago Pharma, Inc.Startup

NCT05514548 / Active, not recruitingPhase 2

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Efficacy, Safety, and Pharmacokinetics of Two Doses of INV-202 in Patients With Diabetic Kidney Disease

Start Date19 Oct 2022

Sponsor / Collaborator

Inversago Pharma, Inc.Startup

[+1]

NCT05282446 / CompletedPhase 1

A Phase 1B Study to Examine the Pharmacokinetic and Pharmacodynamic Effects of INV-202 in Subjects With Metabolic Syndrome as Defined by Hypertriglyceridemia, Abdominal Obesity, and Impaired Glucose Tolerance Over 28 Days.

INV-202-CL-105 is a phase 1B study to examine the safety and tolerability, as well as the pharmacokinetics (PK) pharmacodynamic (PD) effects of INV-202 in subjects with metabolic syndrome over 28 days.

Start Date01 Mar 2022

Sponsor / Collaborator

Inversago Pharma, Inc.Startup

100 Clinical Results associated with Monlunabant

100 Translational Medicine associated with Monlunabant

100 Patents (Medical) associated with Monlunabant

Literatures (Medical) associated with Monlunabant

01 Feb 2024·Diabetes, obesity & metabolism

Effects of CB1R inverse agonist, INV‐202, in patients with features of metabolic syndrome. A randomized, placebo‐controlled, double‐blind phase 1b study

Article

Author: Després, Jean-Pierre ; Lalonde, Karine ; Crater, Glenn D ; Harvey, Michael ; Ravenelle, François

Abstract:

Aims:

To evaluate the clinical safety, tolerability, and pharmacokinetic and pharmacodynamic profile of the novel cannabinoid receptor‐1 (CB1R) inverse agonist, INV‐202, in adults with features of metabolic syndrome.

Materials and Methods:

This was a multicentre, randomized, double‐blind, placebo‐controlled, 28‐day repeat‐dose (INV‐202 [25 mg] or placebo, once‐daily oral tablet), parallel‐group study in 37 participants aged 18 to 65 years (46% female, mean age 55 years, glycated haemoglobin 5.7% [39 mmol/mol], body mass index [BMI] 38.1 kg/m2) with features of metabolic syndrome and glucose intolerance. An oral glucose tolerance test (OGTT) was performed at baseline and at the end of the study. Lipid profiles, weight, waist circumference and biomarkers were assessed weekly. Statistical comparisons were performed post hoc.

Results:

INV‐202 was well tolerated with no serious or severe treatment‐emergent adverse events; the most common events related to known effects of CB1R blockade in the gastrointestinal tract. INV‐202 produced a significant mean weight loss of 3.5 kg (3.3% compared with placebo participants who gained a mean 0.6 kg [0.5%]). INV‐202 also exhibited significant reductions in waist circumference and BMI (P ≤ 0.03). There was no significant difference in OGTT 0‐ to 3‐hour area under the curve for INV‐202 versus placebo: least squares mean 29.38 versus 30.25 h*mmol/L, with an INV‐202: placebo ratio of 97.1% (95% confidence interval 90.2, 105.6; P = 0.43).

Conclusions:

INV‐202 was well tolerated, producing a signal for rapid weight loss with improvements in other metabolic syndrome markers in this population. These findings support further exploration and long‐term assessment of cardiometabolic effects.

01 Jan 2023·Frontiers in nephrology

Therapeutic potential of a novel peripherally restricted CB1R inverse agonist on the progression of diabetic nephropathy.

Article

Author: Pointeau, Océane ; Buch, Chloé ; Jourdan, Tony ; Demizieux, Laurent ; Crater, Glenn ; Belkaid, Rim ; Regazzoni, Isaline ; Passilly-Degrace, Patricia ; Degrace, Pascal ; Vergès, Bruno ; Roger-Villeboeuf, Célia ; Jacquot, Laetitia ; Leemput, Julia

Objective:

This study assessed the efficacy of INV-202, a novel peripherally restricted cannabinoid type-1 receptor (CB1R) inverse agonist, in a streptozotocin-induced type-1 diabetes nephropathy mouse model.

Methods:

Diabetes was induced in 8-week-old C57BL6/J male mice via intraperitoneal injection of streptozotocin (45 mg/kg/day for 5 days); nondiabetic controls received citrate buffer. Diabetic mice were randomized to 3 groups based on blood glucose, polyuria, and albuminuria, and administered daily oral doses for 28-days of INV-202 at 0.3 or 3 mg/kg or vehicle.

Results:

INV-202 did not affect body weight but decreased kidney weight compared with the vehicle group. While polyuria was unaffected by INV-202 treatment, urinary urea (control 30.77 ± 14.93; vehicle 189.81 ± 31.49; INV-202 (0.3 mg/kg) 127.76 ± 20; INV-202 (3 mg/kg) 93.70 ± 24.97 mg/24h) and albumin (control 3.06 ± 0.38; vehicle 850.08 ± 170.50; INV-202 (0.3 mg/kg) 290.65 ± 88.70; INV-202 (3 mg/kg) 111.29 ± 33.47 µg/24h) excretion both decreased compared with vehicle-treated diabetic mice. Compared with the vehicle group, there was a significant improvement in the urinary albumin to creatinine ratio across INV-202 groups. Regardless of the dose, INV-202 significantly reduced angiotensin II excretion in diabetic mice. The treatment also decreased Agtr1a renal expression in a dose-dependent manner. Compared with nondiabetic controls, the glomerular filtration rate was increased in the vehicle group and significantly decreased by INV-202 at 3 mg/kg. While the vehicle group showed a significant loss in the mean number of podocytes per glomerulus, INV-202 treatment limited podocyte loss in a dose-dependent manner. Moreover, in both INV-202 groups, expression of genes coding for podocyte structural proteins nephrin (Nphs1), podocin (Nphs2), and podocalyxin (Pdxl) were restored to levels similar to nondiabetic controls. INV-202 partially limited the proximal tubular epithelial cell (PTEC) hyperplasia and normalized genetic markers for PTEC lesions. INV-202 also reduced expression of genes contributing to oxidative stress (Nox2, Nox4, and P47phox) and inflammation (Tnf). In addition, diabetes-induced renal fibrosis was significantly reduced by INV-202.

Conclusions:

INV-202 reduced glomerular injury, preserved podocyte structure and function, reduced injury to PTECs, and ultimately reduced renal fibrosis in a streptozotocin-induced diabetic nephropathy mouse model. These results suggest that INV-202 may represent a new therapeutic option in the treatment of diabetic kidney disease.

News (Medical) associated with Monlunabant

18 Jun 2024

·www.pharmaceutical-technology.com

Charles River and Captain T Cell sign vector production agreement

To advance its gene-modified cell therapy to clinical stages, Captain T Cell will utilise the plasmid and viral vector production expertise of Charles River. Credit: Hakat / Shutterstock. Charles River Laboratories has entered an agreement with German company Captain T Cell to focus on the production of plasmid DNA and retrovirus vectors for gene-modified cell therapy. The collaboration is part of Charles River’s Cell and Gene Therapy (CGT) Accelerator Program, which provides Captain T Cell with access to contract development and manufacturing organisation (CDMO) expertise and advisory services. The alliance is a strategic move for Captain T Cell as it prepares to manufacture a TCR-T cell therapy aimed at treating solid tumour patients in Phase I clinical trials. Captain T Cell develops treatment options for solid tumours, aiming to extend the reach of T cell immunotherapies to new patient groups. Its approach involves creating T cells equipped with tumour-specific T cell receptors (TCRs) with improved persistence and the ability to withstand the challenging tumour microenvironment of hard-to-treat solid tumours. See Also: Monlunabant by Inversago Pharma for Obesity: Likelihood of Approval Monlunabant by Inversago Pharma for Metabolic Syndrome: Likelihood of Approval The T cells seek out and eliminate tumour cells, potentially offering a new therapeutic avenue for patients whose tumours are resistant to existing treatments. To advance its gene-modified cell therapy to clinical stages, Captain T Cell will utilise the plasmid and viral vector production expertise of Charles River, which has been refined to aid CGT developers from pre-clinical through commercialisation. Charles River has expanded its cell and gene therapy portfolio through acquisitions and facility expansions to streamline complex supply chains and cater to the increasing demand for plasmid DNA, viral vector and cell therapy services. Charles River global manufacturing corporate senior vice-president Kerstin Dolph stated: “We are thrilled to work with the Captain T Cell team to support the manufacture of its TCR-T cell cancer immunotherapy. “Charles River has decades of success reliably manufacturing plasmid DNA, viral vectors and cell therapies, helping to safeguard our customer programmes and bring potential therapies to patients with limited options.” Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Cell and gene therapies: Pipe dream to pipeline The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Cytiva Thematic By downloading this case study, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy

Cell TherapyGene TherapyImmunotherapy

18 Jun 2024

·www.pharmaceutical-technology.com

RevOpsis and Kemwell partner to boost biologic development

Kemwell will produce RO-104 for treating neovascular age-related macular degeneration. Credit: Jo Panuwat D/ Shutterstock. RevOpsis Therapeutics has entered a strategic manufacturing collaboration with contract development and manufacturing organisation Kemwell Biopharma to accelerate the development of new multispecific biologics. The deal speeds up the development of RevOpsis’ lead candidate, RO-104, a tri-specific biologic aimed at treating neovascular age-related macular degeneration (nAMD). Kemwell will concurrently produce RO-104, an asset that can bind three validated targets implicated with nAMD. The alliance will harness the manufacturing prowess of Kemwell alongside RevOpsis’ Rev-Mod platform, to streamline the development process for multispecific biologics. RevOpsis will gain access to a biologics development solution, enabling a swift transition from pre-clinical works to first-in-human clinical trials to advance the development of RO-104 and the broader platform. See Also: Monlunabant by Inversago Pharma for Obesity: Likelihood of Approval Monlunabant by Inversago Pharma for Metabolic Syndrome: Likelihood of Approval Merging the plug-and-play multispecific biologics platform of RevOpsis with the deep biologics development and manufacturing expertise of Kemwell will aid the partnership to quicken the discovery of therapeutics and advance them to investigational new drug (IND) submission. The partnership is designed to link preclinical works, process development and clinical production to lower the complexity and timelines typically associated with handling early Good Manufacturing Practices (GMP) processes. RevOpsis co-founder and interim CEO Ram Bhandari said: “Partnering with Kemwell is a pivotal step in accelerating the development of our lead candidate, RO-104, and advancing our pipeline of innovative multispecific biologics. “Kemwell’s exemplary track record in high-quality biologics manufacturing and their efficiency in reducing timelines, combined with our proprietary Rev-Mod platform, ensures we can deliver transformative therapies to patients efficiently. This collaboration aligns with our mission to develop groundbreaking treatments expeditiously, and bring our innovation to patients worldwide.”

License out/in

17 Jun 2024

·www.pharmaceutical-technology.com

FDA approves Amgen’s BLINCYTO for acute lymphoblastic leukaemia

In a Phase III trial, Amgen’s BLINCYTO plus consolidation chemotherapy significantly improved overall survival versus chemotherapy alone. Credit: JHVEPhoto / Shutterstock. The US Food and Drug Administration (FDA) has approved Amgen ’s BLINCYTO (blinatumomab) for CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukaemia (B-ALL) patients in the consolidation phase. This new indication for BLINCYTO is for adults and paediatric patients aged over one month with B-ALL, irrespective of the measurable residual disease status. The approval is based on the Phase III E1910 clinical trial, led by ECOG-ACRIN Cancer Research Group, which evaluated BLINCYTO in the postinduction consolidation treatment phase of newly diagnosed patients. The study aimed to deepen remission and achieve long-term responses. Trial data showed that adding BLINCYTO to consolidation chemotherapy significantly improved overall survival (OS) compared to chemotherapy alone. See Also: Monlunabant by Inversago Pharma for Obesity: Likelihood of Approval Monlunabant by Inversago Pharma for Metabolic Syndrome: Likelihood of Approval The three-year OS rate was 84.8% for patients receiving BLINCYTO plus chemotherapy, versus 69% for those on chemotherapy alone. After four and a half years of median follow-up, the five-year OS was 82.4% in the BLINCYTO and chemotherapy arm versus 62.5% in the chemotherapy group. Amgen research and development executive vice-president and chief scientific officer Jay Bradner stated: “B-ALL is an aggressive blood cancer with enduring high unmet need. BLINCYTO has helped thousands of patients with B-ALL over the last 10 years. “The approval in the frontline consolidation phase, regardless of MRD status, allows us to reach more patients than ever with this transformative first-in-class bispecific T-cell engager (BiTE) therapy.” BLINCYTO, a (BiTE) immuno-oncology therapy targeting CD19 surface antigens on B cells, has obtained breakthrough therapy and priority review designations from the FDA. It is already approved in the US for multiple indications such as CD19-positive B-ALL in first or second complete remission with MRD ≥0.1%, and relapsed or refractory CD19-positive B-ALL in adults and paediatric patients aged above one month. In May 2024, Amgen‘s Bkemv (eculizumab-aeeb) received FDA approval for use as the first interchangeable biosimilar to Soliris (eculizumab) for the treatment of specific rare diseases.

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Indication	Highest Phase	Country/Location	Organization	Date
Metabolic Syndrome	Phase 2	CA	Inversago Pharma, Inc.Startup	08 Sep 2023
Obesity	Phase 2	CA	Inversago Pharma, Inc.Startup	08 Sep 2023
Diabetic Nephropathies	Phase 2	CA	Inversago Pharma, Inc.Startup	19 Oct 2022
Diabetic Nephropathies	Phase 2	GE	Inversago Pharma, Inc.Startup	19 Oct 2022
Diabetic Nephropathies	Phase 2	HU	Inversago Pharma, Inc.Startup	19 Oct 2022
Diabetic Nephropathies	Phase 2	IL	Inversago Pharma, Inc.Startup	19 Oct 2022
Diabetic Nephropathies	Phase 2	MX	Inversago Pharma, Inc.Startup	19 Oct 2022
Diabetic Nephropathies	Phase 2	RS	Inversago Pharma, Inc.Startup	19 Oct 2022
Glucose Intolerance	Phase 1	CA	Inversago Pharma, Inc.Startup	01 Mar 2022
Hypertriglyceridemia	Phase 1	CA	Inversago Pharma, Inc.Startup	01 Mar 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05282446 (Corporate Publications) Manual	Phase 1	Metabolic Syndrome	37	Monlunabant	yfshdbyxzt(euhymyeifp) = dwpqxqkjly ljyigcbzfg (nrthlnmbkj )	Positive	07 Mar 2024
				Placebo	yfshdbyxzt(euhymyeifp) = bdstwwgcvi ljyigcbzfg (nrthlnmbkj )
NCT05282446 (ADA2023)	Phase 1	Metabolic Syndrome	37	INV-202 25 mg	bedlgfejav(tpygyqvghz) = improvements ufbnuuylgs (skahceilzl ) View more	-	20 Jun 2023
				Placebo

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