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April 19, 2022

Pipeline Moves: Phase II cancer trial of Roche asset terminated, shot at further study drops

Praxis in essential tremor and Altamira in vertigo are also reviewed by Clinical Trials Arena

By Urtė Fultinavičiūtė and Adam Zamecnik

In this week’s Pipeline Moves, we start off with the termination of an investigator-led Phase II cancer study of Roche’s asset. The edition continues with the suspension of a Phase II study in opioid addiction by Astellas Pharma.

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Moving on, we finish with the completion of two Phase II studies, one by Praxis Precision Medicine in essential tremor and the second by Altamira Therapeutics in vertigo.

Want these updates in your inbox? Sign-up for our weekly Pipeline Moves newsletter. You can read last Tuesday’s edition here.

Investigator-led cancer trial terminates

Roche’s Gazyva (obinutuzumab) saw a sharp decrease in its Phase Transition Success Rate (PTSR) in metastatic melanoma and cutaneous T-cell lymphoma after the termination of an investigator-sponsored Phase II trial. It was terminated after recruitment started due to a lack of funding.

The PTSR decreased by 14 points in metastatic melanoma and by 15 points in cutaneous T-cell lymphoma, reaching 20% and 21% respectively. The study was terminated on 5 April and GlobalData reported it on 7 April. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next.

The Phase II open-label, single-arm study (DRKS00017290) evaluated the efficacy of Gazyva and Tecentriq (atezolizumab). The study determined the disease control rate (CR, PR, SD) after treatment with Gazyva or Tecentriq monotherapies, as well as a combined treatment, as one of its primary outcomes.

The University of Cologne in Germany was the trial sponsor. Gazyva is an anti-CD20 antibody approved for the treatment of follicular lymphoma and chronic lymphocytic leukemia. Tecentriq is a PD-L1 immune checkpoint inhibitor, which is indicated for the treatment of urothelial carcinoma, non-small cell lung cancer, small cell lung cancer and hepatocellular carcinoma.

Astellas suspends addiction study

Astellas Pharma’s asset ASP-8062 saw a slump in its PTSR after the Phase II trial was suspended due to corporate strategic considerations.

The PTSR decreased by 19 points to 18% in opium (opioid) addiction. GlobalData evaluated the asset on 12 April after the ClinicalTrials.gov update on 11 April.

The double-blind study (NCT05062577) anticipated to enrol 252 participants with opioid use disorder. The study intended to investigate the safety and efficacy of ASP-8062 as an add-on therapy to Indivior’s Suboxone (buprenorphine/naloxone).

ASP-8062 acts as a GABA-B receptor positive allosteric modulator. The asset binds and activates the GABA-B receptors, helping as a pain reliever and inducing sleep.

Praxis finishes essential tremor trial

Praxis Precision Medicines’ PRAX-944 saw its PTSR in essential tremor rise after a Phase II completion. The PTSR rose by 10 points to 20%. 

The two-part study (NCT05021978) had its status changed to “completed” in an 8 April update on ClinicalTrials.gov. GlobalData updated its system on 11 April.

The 24-subject trial evaluated the efficacy, safety and tolerability of different doses of PRAX-944 against placebo in adult subjects with essential tremor. In the first part of the study, subjects are dosed daily with 20mg of the asset for a week, before moving to 40mg for another seven days. In the second part, subjects are dosed once-daily with titration to 120mg, with varied doses over a 28-day period.

In the first part, the study measured the change from baseline to day seven and day 14 in the Essential Tremor Rating Assessment Scale (TETRAS) upper limb score as a primary outcome. For the second part, the study tracked the incidence and severity of adverse events for 56 days as a primary endpoint.

PRAX-944 is a T-type calcium channel blocker. By blocking such channels, the asset inhibits the calcium-dependent release of neurotransmitters, which are involved in neurological disorders.

Altamira completes Phase II

Altamira Therapeutics’ AM-125 (betahistine dihydrochloride) saw its PTSR in vertigo rise after the completion of a Phase II study. The PTSR rose by nine points to 19%. 

The quadruple-masked study (NCT03908567) had its status changed to “completed” in a 7 April update on ClinicalTrials.gov. GlobalData appraised the asset on 8 April.

The 124-subject study evaluated the efficacy and safety of betahistine dihydrochloride in subjects experiencing vertigo after neurosurgery. The trial measured the improvement of time standing on foam with eyes closed from day three until day 14 as one of its primary outcomes. Adding to this, the trial also assessed the improvement in the tandem Romberg test with eyes closed on the same time frame as an additional primary outcome.

Betahistine dihydrochloride is a histamine H1-agonist and histamine H3-receptor antagonist. It increases cochlear, vestibular, and cerebral blood flow, as well as the release of histamine, acetylcholine, dopamine and norepinephrine.

Additional writing by Clinical Trials Arena healthcare researcher Irena Maragkou

Need to Know:

GlobalData’s proprietary model uses a combination of machine learning and an algorithm to calculate an individual drug’s PTSR. PTSR indicates the probability of a drug’s advancement to the next stage of clinical development. The model uses data points from the individual drugs, clinical trials, regulatory milestones, company, and financial databases.

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