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ADC Therapeutics, Aldeyra start off New Year with program discontinuations

2024-01-04

临床1期抗体药物偶联物

Ringing in the new year for ADC Therapeutics and Aldeyra means ditching clinical development for certain assets.

For ADC Therapeutics and AldADC Therapeutics the Aldeyrar means leaving certain programs behind in 2023.

SwisADC TherapeuticserapeAldeyras discontinuing development of ADCT-901, an antibody drug conjugate (ADC) targeting KAAG that was being evaluated in a phase 1 trial for patients with advanced solid tumors, including platinum-resistant ovarian cancer and triple-negative breast cancer. The trial had a primary completion date in April 2024, according to ClinicalTrials.gov.

Swiss biotechaADC Therapeuticss of efficacy in the dose escalatADCT-901e” prompted the discontinuation, according to a Jan. 4 release. The biotech will focus its resources on precliniadvanced solid tumorss remaining platinum-resistant ovarian cancerich itriple-negative breast cancertrial against various solid tumors, and ADCT-602, which is being assessed in a phase 1 trial in collaboration with MD Anderson Cancer Center for patients with relapsed or refractory acute lymphoblastic leukemia.

ADC Therapeutics ended 2023 with $278.5 million in cash and cash equivalents on hand, money that is expected to stretch into the fourth quarter of 2025. The company expects its belt-tightening to cut total operating expenses for both 202ADCT-60124 in comparison to 2022.solid tumors ADCT-602 MD Anderson Cancer Center Cancer relapsed or refractory acute lymphoblastic leukemia

ADC Therapeuticsra Therapeutics has deprioritized ADX-629, an investigational, orally administered reactive aldehyde species (RASP) modulator that was designed to tackle chronic cough and idiopathic nephrotic syndrome. The Massachusetts-based biotech cited regulatory and trial feasibility challenges for the discontinuation in each respective indication.

Aldeyra hasAldeyra Therapeuticsfocus to a new precADX-629 RASP modulator program in metabolic disease.chronic cough idiopathic nephrotic syndrome

The discontinuation follows a November rejection from the RASPfor Aldeyra’s dry eye metabolic diseasethough the biotech said at the time that it will zip through a brand new trial to get the application back to the agency within the first half of 2024.

The official complete response letter states that Aldeyra FDAled to demonstrate “efficacyreproxalapng ocular symptoms associated with dry eyes,” with the FDA requesting a new trial to show a positive effect on ocular symptoms of dry eye disease.

Last week, Aldeyra received feedback from the FDA on reproxalap and has subsequently amended the proposed clinical trial protocol and dry eyescal analysisFDAan, according to a Jan. 4 release.dry eye disease

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