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June 30, 2021

LoA Update: Pipeline Therapeutics’ PIPE-505 for hearing loss vaults nine points in chances to advance to next development stage after Phase I/IIa completion

Pipeline Therapeutics’ PIPE-505 for acute sensorineural hearing loss had its Phase Transition Success Rate (PTSR) jump nine points to 56% after completing its Phase I/IIa trial.

By Manasi Vaidya

Pipeline Therapeutics’ PIPE-505 for acute sensorineural hearing loss had its Phase Transition Success Rate (PTSR) jump nine points to 56% after completing its Phase I/IIa trial. The PTSR change occurred on 25 June after the trial’s ClinicalTrials.gov listing was updated as completed on 23 June. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next.

The San Diego, California-based company enrolled 28 patients in the Phase I/IIa trial (NCT04462198), which was four patients higher than planned, as per its ClinicalTrials.gov listing. Patients were randomized to either receive an intratympanic dose of PIPE-505 or placebo, with safety as the primary endpoint.

PIPE-505 is a gamma secretase inhibitor that targets two pathways associated with sensorineural hearing loss and audibility. Previously, Pipeline completed a USD 80m Series C raise for the development of this asset as well as for its multiple sclerosis asset PIPE-307, according to an 11 February press release.

The completed Phase I/IIa also led to a modest 1-point bump on PIPE-505’s Likelihood of Approval (LoA), which rose to 2%. LoA is identified via GlobalData’s analysis using a combination of machine learning and its proprietary algorithm. It is calculated by compounding the PTSR at each stage the drug is yet to progress through. Both LoA and PTSR can be calculated for a drug by considering characteristics like therapy area, indication and molecule type.

Manasi Vaidya is a Associate Editor for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.

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