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RAPT terminates Phase II trials for lead candidate following clinical hold

2024-05-10

临床2期临床结果临床失败

RAPT Therapeutics’ zelnecirnon is a C-C motif chemokine receptor 4 (CCR4) agonist. Image Credit: Jennie Book / Shutterstock.

RAPT Therapeutics hzelnecirnond planC-C motif chemokine receptor 4 (CCR4)r its lead candidate, zelnecirnon (RPT193), three months after the US Food and Drug Administration (FDA) placed a clinical hold on them.

RAPT TherapeuticsUS regulatory agency placed a clinical hold on the Phase IIa (NCT05935332) and Phase IIb trials (NCT05399368) that evaluated zFood and Drug Administration (FDA)d moderate to severe asthma, respectively. The hold was placed after a patient in the atopic dermatitis trial suffered liver failure possibly caused by zelnecirnon.

Following the trial termination news, RAPT’s stock was down by 41.7% at market close on 9 May, compared to market close on the previous day. Szelnecirnoninicatopic dermatitisnced on 20 February, theasthmany’s stock has dropped by over 82% compared to its peak befatopic dermatitisT ended Q1 with liver failuresh reserves and a nezelnecirnon30.5m. Rapt’s market cap is $150m.

Before the clinical hold, approximatelRAPT0 out of the 229 patients enrolled in the atopic dermatitis study had completed the 16-week dosing schedule. RAPT said this data will be “sufficient data, even if not statistically significant, to inform our path forward and support ouRAPTscussions with the FDA.”Rapt

The company’s president and CEO, Brian Wong added: “We are working with the clinicalatopic dermatitislean the data and we anticipate that our analysis of the data will be completed in the third quarter of this year. Concurrently, we are continuing our investigation and analysis of the serious adversFDAvent that triggered the clinical hold.”

See Also:How to identify and remove CNS assessments errors before jeopardising a trial

Zelnecirnon is a small molecule C-C motif chemokine receptor 4 (CCR4) agonist. CCR4 is expressed by several immune cells such as T helper 2 (TH2) cells, regulatory T cells (Tregs), mast cells, and skin-homing lymphocyte Ag–positive T cells. Its inhibition results in a muted or absent inflammatory response in patients with asthma and dermatitis. Although the exact functions of CCR4 are not known, recent studies indicate that CCR4 plays an important role in the pathogenesis of various diseases including asthma, dermatitis, cancer and diabetes.

A US FDA clinical hold on a programme can harm an investigational drug’s development prospects. However, there have been cases where the agency has lifted the hold either partially or fully to allow companies to resume clinical trials. Cytodyn waited over two years for the US FDA to lift the clinical hold on its HIV therapy, leronlimab.

Zelnecirnoncirnon, the company’sC-C motif chemokine receptor 4 (CCR4)mecirnon (CCR475), which is also a CCR4 agonist, similar to zelnecirnon. CCR4 is expressed by Tregs, which are involved in tumour development and progression, and its inhibition leads to an antitumour response.asthma dermatitis CCR4 CCR4 asthma dermatitis cancer diabetes

ThUS FDAany is evaluating tivumecirnon as a combination therapy with Merck & Co’s Keytruda (pembrolizumab) as a treatment for advanced head and neck squamous cell carcinoma (HNSCC) in an open label Phase II trial (NCT03674567). Last monCytodynT shared results from 32 patienUS FDAolled in the Phase II trial. The participants dleronlimabd an objective response rate (ORR) of 15.6%.

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