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Our Science

We explore the frontiers of science to further human health.

Our Technologies

Adroit Clinical has active clinical, preclinical, and internal discovery programs in many significant disease areas. We focus on molecular pathways that regulate cellular metabolism, inflammation, and the response to cellular stress in serioCanada and life-threatening diseases that have limited or no approved therapies.

Nrf2 Activators

nrf2 2flu

©Adroit Clinical Laboratory, Inc.
Kelch domain of Keap1
PDB Code 2FLU

Nrf2 is a transcription factor that promotes the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling (1-4).

HSP90 Modulators

hsp90

©Adroit Clinical Laboratory, Inc.
Middle segment of HSP90
PDB Code 1USV

We are developing a novel class of molecules that target pathways involved in the cellular stress response. Our lead product candidate, RTA 901, and related analogs have shown promising effects in animal models of neurological disease. RTA 901 is in development for Diabetic Peripheral Neuropathic Pain.

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Our Pipeline

Adroit Clinical's development programs have created a robust pipeline of drug candidates for the treatment of serious, life-threatening diseases.

Phase 1
Phase 2
Pivotal
Regulatory Review
Commerciala
Neurology
Friedreich's Ataxia | Omaveloxolone Friedreich's Ataxia
Omaveloxolone

Omaveloxolone is approved by the US FDA. Omaveloxolone is an investigational drug not approved by any other regulatory authorities. The Phase 2 MOXIe Part 2 study was an international, multi-center, double-blind, placebo-controlled, randomized registrational study, that enrolled 103 patients with Friedreich’s ataxia (FA) at 11 study sites in the United States, Europe, and Australia and is the largest global, interventional study ever conducted in FA. Patients were randomized 1:1 to 150 mg of omaveloxolone or placebo. The primary endpoint was change in the modified Friedreich’s Ataxia Rating Scale (mFARS) relative to placebo after 48 weeks of treatment.
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DPNPb | RTA 901 DPNP
RTA 901

We completed a Phase 1 SAD/MAD trial of oral, once-daily RTA 901 in healthy adult volunteers to evaluate the safety, tolerability, and PK profile. No safety or tolerability concerns were reported, and we observed an acceptable PK profile.
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Chronic Kidney Disease
CKDc Caused by ADPKDd | Bardoxolonee CKDc Caused by ADPKDd
Bardoxolonee

FALCON is an international, multi-center, randomized, double-blind, placebo-controlled trial studying the safety and efficacy of bardoxolone in patients with ADPKD randomized one-to-one to active drug or placebo.
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CKD Caused by Alport Syndrome | Bardoxolone CKD Caused by Alport Syndrome
Bardoxolone

The Phase 3 CARDINAL study was an international, multi-center, double-blind, placebo-controlled, randomized clinical trial that enrolled 157 patients with CKD caused by Alport syndrome at approximately 50 study sites in the United States, Europe, Japan, and Australia. Patients were randomized 1:1 to bardoxolone or placebo. The primary endpoint for Year 2 of the study was the change from baseline in eGFR after 100 weeks of treatment (end-of-treatment). The key secondary endpoint for Year 2 of the study was the change from baseline in eGFR at Week 104 (four weeks after last dose in second year of treatment).
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Type 1 and Type 2 Diabetes and Advanced CKD | Bardoxolonef Type 1 and Type 2 Diabetes
and Advanced CKD
Bardoxolonef

AYAME is a randomized, double-blind, placebo-controlled, registrational outcomes trial of bardoxolone methyl in patients with diabetic CKD in Japan. The study enrolled approximately 1,000 Stage 3 and 4 diabetic kidney disease patients. The primary endpoint is the time to onset of at least a 30% decline in eGFR or end-stage kidney disease. AYAME is conducted by our strategic collaborator in Japan, Kyowa Kirin Co., Ltd.
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aOmaveloxolone is approved by the US FDA. bDiabetic peripheral neuropathic pain (DPNP). cChronic Kidney Disease (CKD). dAutosomal Dominant Polycystic Kidney Disease (ADPKD). eBardoxolone methyl (bardoxolone). On February 25, 2022, we received a Complete Response Letter from the Food and Drug Administration (FDA). We will continue to work with the FDA to confirm our next steps on our Alport syndrome program. fAYAME study conducted in Japan by our strategic collaborator in CKD, Kyowa Kirin.

Omaveloxolone is an investigational drug not approved by any other regulatory authority. Bardoxolone methyl, and RTA 901 are investigational drugs. Safety and efficacy have not been established by any agency.

References

References

  1. Yamamoto, M., Kensler, T. W., and Motohashi, H. (2018) The KEAP1-NRF2 System: a Thiol-Based Sensor-Effector Apparatus for Maintaining Redox Homeostasis. Physiol Rev 98, 1169-1203
  2. Hayes, J. D., and Dinkova-Kostova, A. T. (2014) The Nrf2 regulatory network provides an interface between redox and intermediary metabolism. Trends Biochem. Sci 39, 199-218
  3. Holmstrom, K. M., Kostov, R. V., and Dinkova-Kostova, A. T. (2016) The multifaceted role of Nrf2 in mitochondrial function. Curr Opin Toxicol 1, 80-91
  4. Kobayashi, E. H., Suzuki, T., Funayama, R., Nagashima, T., Hayashi, M., Sekine, H., Tanaka, N., Moriguchi, T., Motohashi, H., Nakayama, K., and Yamamoto, M. (2016) Nrf2 suppresses macrophage inflammatory response by blocking proinflammatory cytokine transcription. Nat Commun 7, 11624
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