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- azelaprag (BGE-105) / BioAge Labs
Activation of Apelin Receptor Inhibits Cystogenesis in a Mouse Model of Polycystic Kidney Disease (Exhibit Hall, Convention Center) - Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_2881;
Targeting apelin receptor signaling may be a novel therapeutic strategy for treating ADPKD. Future experiments will explore the molecular mechanisms mediating the effects of apelin on cystogenesis.
- azelaprag (BGE-105) / BioAge Labs
Macrocyclic peptides and small molecules targeting the apelin receptor as promising analgesics (MCP Hall A) - Aug 22, 2024 - Abstract #Neuroscience2024Neuroscience_3699;
We also used a scaffold-hoping strategy to create new druggable small-molecule ligands starting from the first identified G?i-biased small-molecule ligand at APJ, CMF-019, and studied their functional activity in comparison with other small-molecule agonists (BMS986224, AMG986)...The small molecule LT02-20 was also effective in reversing the formalin-induced pain behaviors, while the parent compound CMF-019 had no analgesic effect. Overall, these results highlight the therapeutic potential of biased macrocyclic APJ analogs and small molecules for managing pain.
- ||||| azelaprag (BGE-105) / BioAge Labs
New P2 trial: STRIDES: Efficacy and Safety of Oral Azelaprag Plus Once Weekly Tirzepatide Compared with Tirzepatide Alone in Participants with Obesity Aged 55 Years and Over (clinicaltrials.gov) - Jul 23, 2024
P2, N=220, Recruiting, Sponsor: BioAge Labs, Inc.
- azelaprag (BGE-105) / BioAge Labs
The Apelin Receptor Agonist Azelaprag Increases Weight Loss in Diet-Induced Obese Mice on Incretin Agonists and Restores Body Composition and Muscle Function to That of Lean Controls (W415C (Valencia Ballroom)) - May 20, 2024 - Abstract #ADA2024ADA_1235;
Addition of azelaprag to incretin regimens increased weight loss while restoring body composition and muscle function relative to monotherapy. In the clinic, combination therapy has the potential to amplify healthy weight loss, enabling next-generation oral incretin drugs to achieve efficacy comparable to current injectables with improved tolerability.
- || azelaprag (BGE-105) / BioAge Labs
Trial completion: Pharmacokinetics Study of Azelaprag (BGE-105) in Older Adult Healthy Volunteers (clinicaltrials.gov) - Feb 26, 2024
P1, N=16, Completed, Sponsor: BioAge Labs, Inc.
In the clinic, combination therapy has the potential to amplify healthy weight loss, enabling next-generation oral incretin drugs to achieve efficacy comparable to current injectables with improved tolerability. Not yet recruiting --> Completed
- || azelaprag (BGE-105) / BioAge Labs
New P1 trial: Pharmacokinetics Study of Azelaprag (BGE-105) in Older Adult Healthy Volunteers (clinicaltrials.gov) - Nov 21, 2023
P1, N=16, Not yet recruiting, Sponsor: BioAge Labs, Inc.
- azelaprag (BGE-105) / BioAge Labs
Activation of the apelin receptor, implicated in a key aging pathway by analysis of longitudinal human data, ameliorates multiple mechanisms that drive neuroinflammation and neurodegeneration (WCC Halls A-C) - Nov 3, 2023 - Abstract #Neuroscience2023NEUROSCIENCE_8294;
Daily oral administration of BGE-105 for 7 days suppressed circulating levels of age-related proinflammatory cytokines, increased levels of BDNF in the hippocampus, and reversed age-induced BBB dysfunction, suggesting that BGE-105 restores the BBB through its anti-inflammatory effects in the periphery. Taken together, our results suggest that apelin receptor agonism with an orally available small molecule represents a novel approach for treating chronic age-related neuroinflammation and neurodegeneration, and for mitigating the effects of inflammation on the BBB.
- || azelaprag (BGE-105) / BioAge Labs
P1 data, PK/PD data, Journal: A Phase 1, Open-Label Study to Evaluate the Effect of Food and Concomitant Itraconazole Administration on the Pharmacokinetics of AMG 986 in Healthy Subjects. (Pubmed Central) - Jul 6, 2022
In conclusion, food had no apparent effect on the exposure of AMG 986 200 mg; therefore, food restrictions are not required. Potent cytochrome P450 3A4 and/or P-glycoprotein inhibitors may warrant AMG 986 dose reduction and should be coadministered with caution in patients with heart failure treated with AMG 986.
- || AMG 986 /
PK/PD data, Journal: A Phase I, Open-label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of AMG 986 in Healthy Japanese Subjects. (Pubmed Central) - Jun 9, 2022
AMG 986 exposure increased with increasing dose, and the increase was less than dose proportional in healthy Japanese subjects. The results of this study could facilitate the subsequent clinical development of AMG 986 for the treatment of Japanese patients with HF.
- || AMG 986 /
PK/PD data, Journal: Evaluation of the Pharmacokinetics and Safety of AMG 986 Tablet and Capsule Formulations in Healthy Adult Subjects: A Phase I, Open-Label, Randomized Study. (Pubmed Central) - Jun 9, 2022
There was a modest 12% decrease in AUC and a 28% decrease in C with the AMG 986 capsule versus the tablet. These differences are not considered to be clinically relevant, suggesting the capsule formulation can be used in subsequent clinical studies of AMG 986.
- || azelaprag (BGE-105) / BioAge Labs
P1 data, Journal: A First-in-Human Study of AMG 986, a Novel Apelin Receptor Agonist, in Healthy Subjects and Heart Failure Patients. (Pubmed Central) - Apr 24, 2022
P1
Consistent with this observation, clinically meaningful pharmacodynamic effects in HF patients were not observed. Changes in ejection fraction and stroke volume in HF patients suggest additional studies may be needed to better define the clinical utility and optimal dosing for this molecule.
- || AMG 986 /
PK/PD data, Journal: Effect of Severe Renal Impairment on the Safety, Tolerability, and Pharmacokinetics of AMG 986. (Pubmed Central) - Mar 3, 2022
P1
Changes in ejection fraction and stroke volume in HF patients suggest additional studies may be needed to better define the clinical utility and optimal dosing for this molecule. The results of this study support the enrollment of HF patients with RI to clinical trials of AMG 986 without the need for dose adjustments.
- AMG 986 /
[VIRTUAL] Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Amg 986, A Novel Small Molecule Apelin Receptor Agonist, In Healthy Subjects And Heart Failure Patients (Poster Hall - ePosters) - Sep 10, 2020 - Abstract #HFSA2020HFSA_277;
The results of this study support the enrollment of HF patients with RI to clinical trials of AMG 986 without the need for dose adjustments. In healthy subjects and in HF patients, short-term treatment with AMG 986 was well tolerated.
- |||| azelaprag (BGE-105) / BioAge Labs
Trial completion date, Trial termination, Trial primary completion date: Study to Evaluate the Safety and Tolerability of AMG 986 in Healthy Volunteers and Heart Failure Patients (clinicaltrials.gov) - May 8, 2019
P1, N=182, Terminated, Sponsor: Amgen
Trial completion date: Jul 2019 --> Apr 2019 | Recruiting --> Terminated | Trial primary completion date: Jul 2019 --> Apr 2019; Terminated (Decision by the Sponsor. The study was not terminated due to a safety reason.)
- || azelaprag (BGE-105) / BioAge Labs
Trial completion date, Trial primary completion date: Study to Evaluate the Safety and Tolerability of AMG 986 in Healthy Volunteers and Heart Failure Patients (clinicaltrials.gov) - Oct 23, 2018
P1, N=192, Recruiting, Sponsor: Amgen
The study was not terminated due to a safety reason.) Trial completion date: Dec 2018 --> Jul 2019 | Trial primary completion date: Dec 2018 --> Jul 2019
- azelaprag (BGE-105) / BioAge Labs
Enrollment closed: Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 986 Administered Orally to Healthy Volunteers and Participants With Severely Impaired Renal Function (clinicaltrials.gov) - Mar 15, 2018
P1, N=12, Active, not recruiting, Sponsor: Amgen
Trial completion date: Dec 2018 --> Jul 2019 | Trial primary completion date: Dec 2018 --> Jul 2019 Recruiting --> Active, not recruiting
- azelaprag (BGE-105) / BioAge Labs
Enrollment open: Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 986 Administered Orally to Healthy Volunteers and Participants With Severely Impaired Renal Function (clinicaltrials.gov) - Dec 26, 2017
P1, N=12, Recruiting, Sponsor: Amgen
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- azelaprag (BGE-105) / BioAge Labs
Trial primary completion date: Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 986 Administered Orally to Healthy Volunteers and Participants With Severely Impaired Renal Function (clinicaltrials.gov) - Dec 6, 2017
P1, N=12, Not yet recruiting, Sponsor: Amgen
Not yet recruiting --> Recruiting Trial primary completion date: Feb 2018 --> Jun 2018
- || azelaprag (BGE-105) / BioAge Labs
Trial primary completion date: Study to Evaluate the Safety and Tolerability of AMG 986 in Healthy Volunteers and Heart Failure Patients (clinicaltrials.gov) - Nov 7, 2017
P1, N=192, Recruiting, Sponsor: Amgen
Trial primary completion date: Feb 2018 --> Jun 2018 Trial primary completion date: Mar 2018 --> Jul 2018
- | azelaprag (BGE-105) / BioAge Labs
New P1 trial: Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 986 Administered Orally to Healthy Volunteers and Participants With Severely Impaired Renal Function (clinicaltrials.gov) - Oct 24, 2017
P1, N=12, Not yet recruiting, Sponsor: Amgen
- ||| azelaprag (BGE-105) / BioAge Labs
New P1 trial: Study to Evaluate the Safety and Tolerability of AMG 986 in Healthy Volunteers and Heart Failure Patients (clinicaltrials.gov) - Sep 7, 2017
P1, N=192, Recruiting, Sponsor: Amgen