Roche Halts Six Clinical Programs, Including Two Phase III Trials, in Pipeline Cleanup

Compiled by Fan Dongdong

On April 22, Roche announced its financial results for the first quarter of 2020, with global sales reaching CHF 15.1 billion, a year-on-year increase of 2%. Among these, sales in the pharmaceuticals division grew by 7% to CHF 12.3 billion. Notably, Roche conducted a “cleanup” of its clinical pipeline in the first quarter, discontinuing six clinical projects, including two Phase III trials.

Roche Halts Two Phase 3 Clinical Programs, One of Which Involves the Investigational Oral Drug Balovaptan (RG7314)Roche has discontinued two Phase 3 clinical programs, one of which involves the investigational oral drug balovaptan (RG7314). Balovaptan is a vasopressin 1a (V1a) receptor antagonist intended for the treatment of patients with autism spectrum disorder (ASD) and was granted Breakthrough Therapy designation by the U.S. FDA in January 2018. Previously, a study conducted in adult males with autism showed that balovaptan demonstrated therapeutic advantages in terms of social function scores; while higher doses improved adaptive behavior scores, the results did not reach statistical significance. Roche disclosed that a study of balovaptan in adult patients with autism was terminated in the first quarter of this year following a pre-planned futility analysis. No detailed information regarding the future development of the drug has been released.

In fact, the entire pharmaceutical industry has encountered a bottleneck in the development of effective treatments for autism; besides Roche, Novartis and Seaside Therapeutics have also canceled their related drug development programs.

Roche Halts Another Phase 3 Clinical Program Involving the MDM2 Inhibitor Idasanutlin (RG7388)Last September, Roche announced that it was conducting a Phase 3 clinical trial to evaluate the efficacy of idasanutlin in combination with cytarabine for the treatment of patients with relapsed/refractory acute myeloid leukemia (AML). The company was also exploring the efficacy of this candidate drug in combination with other agents for the treatment of various types of leukemia. Although there had been high expectations for the drug, this unexpected news has emerged. Additionally, another Phase 2 clinical trial of idasanutlin for polycythemia vera has been discontinued.

The ongoing Phase 2 clinical trial of basmisanil (RG1662) has also been halted. Basmisanil is a highly selective inverse agonist/negative allosteric modulator of GABA_A receptors containing the α3 subunit, and was previously considered to have potential for treating Down syndrome-associated cognitive impairment.

Last September, Roche announced that prasinezumab, a Parkinson’s disease therapy developed in collaboration with Prothena, had completed Phase I clinical trials, with Phase II results expected in 2020. Prasinezumab is a monoclonal antibody targeting alpha-synuclein aggregates. Roche further stated that the Phase II trial of prasinezumab did not meet its primary endpoint but showed signals of efficacy. The company is currently evaluating the trial data to determine the next steps for the drug’s development.

Roche’s latest trial portfolio exclusions also include emolizumab, a monoclonal antibody that blocks IL-31 signaling, currently being tested for pruritus in dialysis patients and atopic dermatitis.

Reference Source: Roche Culls Key Phase 3 Drug Trials, Including a Cancer Med and an Autism 'Breakthrough' Therapy