CYP17A1 inhibitors

Akero Therapeutics Presents at the American Diabetes Association’s 81st Scientific Sessions, Demonstrating that Improvements in Adipose Tissue Metabolism Contributed Substantially to Improved Liver Health and Better Glycemic Control in Efruxifermin (EFX

Retrieved on: 
Friday, June 25, 2021

The posters are available starting at 11:30am ET on June 25, 2021 and will be posted to the companys website.

Key Points: 
  • The posters are available starting at 11:30am ET on June 25, 2021 and will be posted to the companys website.
  • These improvements, including a clinically meaningful and statistically significant reduction in HbA1c, were seen on top of concomitant anti-diabetic medications.
  • These secondary analyses highlight the potential of FGFR1c-mediated reprogramming of adipose metabolism in NASH patients to improve liver health.
  • Insulin-sensitizing therapeutics acting predominantly on adipose tissue, such as pioglitazone, have historically been associated with weight gain.

Strongbridge Biopharma plc Announces Issuance of Patent for RECORLEV® (levoketoconazole) for the Treatment of Cushing’s Syndrome

Retrieved on: 
Thursday, June 3, 2021

11,020,393 entitled, Methods of Treating Disease with Levoketoconazole which covers a method of treating Cushings syndrome patients with RECORLEV (levoketoconazole) who also take metformin for Type 2 diabetes.

Key Points: 
  • 11,020,393 entitled, Methods of Treating Disease with Levoketoconazole which covers a method of treating Cushings syndrome patients with RECORLEV (levoketoconazole) who also take metformin for Type 2 diabetes.
  • 9,918,984, covers methods of treating Cushings syndrome with levoketoconazole and will expire on January 10, 2026.
  • RECORLEV is an adrenal steroidogenesis inhibitor with a New Drug Application that is currently under review by the U.S. Food and Drug Administration for the treatment of endogenous Cushings syndrome.
  • RECORLEV has received orphan drug designation from the FDA and theEuropean Medicines Agencyfor the treatment of endogenous Cushing's syndrome.

Propella Therapeutics Receives FDA Clearance to Begin Phase 1 Clinical Study of Novel Prostate Cancer Treatment

Retrieved on: 
Wednesday, May 19, 2021

Under the IND, Propella plans to initiate an open-label, phase 1/2a clinical study in June 2021.

Key Points: 
  • Under the IND, Propella plans to initiate an open-label, phase 1/2a clinical study in June 2021.
  • "We have strong preclinical data, and we\'re excited to be initiating a first-in-human trial.
  • The acetate prodrug of abiraterone is the current standard of care for advanced prostate cancer.
  • "\nToday, Propella also announced the appointment of Brendan Griffin to its leadership team asthe company\'s Chief Financial Officer(CFO).

Strongbridge Biopharma plc Announces Submission of New Drug Application for RECORLEV® (levoketoconazole) for the Treatment of Endogenous Cushing’s Syndrome to the U.S. Food & Drug Administration

Retrieved on: 
Tuesday, March 2, 2021

The submission of the New Drug Application for RECORLEV (levoketoconazole) represents not only a significant milestone for Strongbridge but also for the Cushings syndrome community as a whole.

Key Points: 
  • The submission of the New Drug Application for RECORLEV (levoketoconazole) represents not only a significant milestone for Strongbridge but also for the Cushings syndrome community as a whole.
  • RECORLEV, the pure 2S,4R enantiomer of the enantiomeric pair comprising ketoconazole, is a next-generation steroidogenesis inhibitor being investigated as a chronic therapy for adults with endogenous Cushings syndrome.
  • RECORLEV has received orphan drug designation from the FDA and theEuropean Medicines Agencyfor the treatment of endogenousCushing'ssyndrome.
  • ET to discuss the Companys fourth quarter and full-year 2020 financial results and recent corporate highlights, including the RECORLEV NDA submission.

Janssen Presents Results from Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Apalutamide▼ and Abiraterone Acetate Combination

Retrieved on: 
Tuesday, February 9, 2021

The safety profile was consistent with prior studies of apalutamide, with no new safety signals observed.

Key Points: 
  • The safety profile was consistent with prior studies of apalutamide, with no new safety signals observed.
  • ACIS is a Phase 3 randomised, double-blind, placebo-controlled, multicentre clinical study evaluating the efficacy and safety of apalutamide and abiraterone acetate plus prednisone compared to placebo and abiraterone acetate plus prednisone in 982 patients with chemotherapy-nave mCRPC disease who received ADT.1 Patients were randomised to receive either apalutamide and abiraterone acetate plus prednisone, or placebo and abiraterone acetate plus prednisone.
  • Dana E. Final Results From ACIS, a Randomized, Placebo (PBO)-Controlled Double-Blind Phase 3 Study of Apalutamide (APA) and Abiraterone Acetate Plus Prednisone (AAP) Versus AAP in Patients (Pts) With Chemo-Naive Metastatic Castration-Resistant Prostate Cancer (mCRPC).
  • ZYTIGA (abiraterone acetate) Plus Prednisone Approved for Treatment of Earlier Form of Metastatic Prostate Cancer.

Poxel Announces Upcoming Poster Presentations at AASLD The Liver Meeting® 2020

Retrieved on: 
Monday, November 9, 2020

Pioglitazone is the only drug recommended for biopsy-proven NASH patients by the Practice Guidelines published by the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL)2.

Key Points: 
  • Pioglitazone is the only drug recommended for biopsy-proven NASH patients by the Practice Guidelines published by the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL)2.
  • In in vitro studies, PXL065 has been shown to target mitochondrial pyruvate carrier (MPC) as an inhibitor.
  • Based upon preclinical and Phase 1 results to date, Poxel believes that PXL065 may have a better therapeutic profile than pioglitazone for NASH.
  • Poxel also has additional earlier-stage programs from its AMPK activator and deuterated TZD platforms targeting chronic and rare metabolic diseases.

Poxel Announces Presentation of PXL065 Phase 1a Results at the Liver Meeting® 2019

Retrieved on: 
Tuesday, November 12, 2019

POXEL SA (Euronext: POXEL FR0012432516), a biopharmaceutical company focused on the development of innovative treatments for metabolic disorders, including type 2 diabetes and non-alcoholic steatohepatitis (NASH), today announced the presentation of PXL065 Phase 1a results during a poster presentation session at the Liver Meeting 2019 hosted by the American Association for the Study of Liver Diseases (AASLD).

Key Points: 
  • POXEL SA (Euronext: POXEL FR0012432516), a biopharmaceutical company focused on the development of innovative treatments for metabolic disorders, including type 2 diabetes and non-alcoholic steatohepatitis (NASH), today announced the presentation of PXL065 Phase 1a results during a poster presentation session at the Liver Meeting 2019 hosted by the American Association for the Study of Liver Diseases (AASLD).
  • In the poster presentation, PXL065 was observed to have a favorable safety, tolerability and PK profile in the Phase 1a trial.
  • Based on preclinical and clinical results, I am excited about the potential for an improved therapeutic profile for PXL065 compared to pioglitazone.
  • Based upon preclinical and Phase 1 results to date, Poxel believes that PXL065 may have a better therapeutic profile than pioglitazone for NASH.

Poxel Announces Positive Update Following FDA Meeting for PXL065 for Treatment of NASH

Retrieved on: 
Friday, November 8, 2019

PXL065, the deuterium-stabilized R-stereoisomer of pioglitazone, is a mitochondrial pyruvate carrier (MPC) inhibitor being developed for the treatment of NASH.

Key Points: 
  • PXL065, the deuterium-stabilized R-stereoisomer of pioglitazone, is a mitochondrial pyruvate carrier (MPC) inhibitor being developed for the treatment of NASH.
  • We plan to initiate a Phase 2 trial for PXL065 for the treatment of NASH during the second quarter of 2020 in biopsy-proven NASH patients.
  • Based upon preclinical and Phase 1 results to date, Poxel believes that PXL065 may have a better therapeutic profile than pioglitazone for NASH.
  • PXL065 (deuterium-stabilized R-pioglitazone), a mitochondrial pyruvate carrier (MPC) inhibitor, is in Phase 1 clinical testing and being developed for the treatment of NASH.

DRGT Announces First Subject Dosed in a Phase I Clinical Trial of DRGT 45, a Novel Formulation of Abiraterone Acetate for Prostate Cancer

Retrieved on: 
Tuesday, October 29, 2019

DRGT-45 (abiraterone acetate), is a second-generation prostate cancer therapy therapy that inhibits the production of testosterone, which is implicated in the growth of prostate cancer, through blockade of CYP17.

Key Points: 
  • DRGT-45 (abiraterone acetate), is a second-generation prostate cancer therapy therapy that inhibits the production of testosterone, which is implicated in the growth of prostate cancer, through blockade of CYP17.
  • All currently available formulations of abiraterone acetate necessitate ingeston of multiple large tablets.
  • This open-label Phase I trial is conducted under an Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA).
  • The first part of the trial will evaluate the pharmacokinetic profile of a single-dose DRGT-45 using a dose escalation protocol.

MSN Labs/Novadoz Pharmaceuticals Early Success Continues With FDA Approval Of Generic Abiraterone

Retrieved on: 
Monday, July 15, 2019

PISCATAWAY, N.J., July 15, 2019 /PRNewswire/ --MSN Labs, the parent company of Novadoz Pharmaceuticals, was granted FDA approval to market Abiraterone Acetate 250mg tablets, a generic version of Janssen Pharmaceuticals'product Zytiga, on July 9th.

Key Points: 
  • PISCATAWAY, N.J., July 15, 2019 /PRNewswire/ --MSN Labs, the parent company of Novadoz Pharmaceuticals, was granted FDA approval to market Abiraterone Acetate 250mg tablets, a generic version of Janssen Pharmaceuticals'product Zytiga, on July 9th.
  • This FDA approval marks the ninth since March 2018, when Novadoz began commercial operations as MSN Labs' U.S sales and marketing affiliate for their finished dosage forms.
  • MSN's approval for Abiraterone Acetate 250mg tablets, in the class of oncology drugs indicated for the treatment of prostate cancer when used with a steroid medication (prednisone or methylprednisolone).
  • "The approval of generic Abiraterone is a significant for our organization as it continues to fill our portfolio with important products, most specifically those used in the oncology class.