Provention Bio Inc (NASDAQ: PRVB) recently announced the receipt of a Complete Response Letter (CRL) from the USFDA regarding its Teplizumab’s Biologics License Application. Teplizumab is the company’s lead portfolio candidate anticipated to delay the progression of clinical Type-1 Diabetes in individuals at risk. However, the CRL didn’t mention any deficiencies related to the clinical safety and efficacy data submitted towards the Biologics License Application. In addition, it also confirmed the acceptability of the proposed proprietary name for the biologic Teplizumab. The letter also contained additional comments and recommendations, which do not impact approvability or resubmission process related to Teplizumab. However, the stock plunged 25% in Monday’s trade.
Critical comments in the Complete Response Letter
In the CRL received by Provention, the USFDA stated that a pharmacokinetic / pharmacodynamics (PK/PD) bridging study in healthy volunteers had failed to suggest PK comparability. The letter further asked the company to establish PK comparability between the clinical trial product and the intended commercial product or provide data to justify why such comparability is not required. Provention anticipates collecting PK/PD data from a sub-study within the ongoing Phase-3 PROTECT trial. Independent third-party evaluators shall analyze this data to maintain the integrity of this clinical trial. The USFDA has also requested Provention to provide a safety update during a resubmission of its Biologics License Application.
Additional comments & Provention’s anticipations
The USFDA has also cited some considerations related to product quality in the CRL. Provention maintains that such considerations are either addressed in amendments submitted to the USFDA or addressed in the short term. The CRL indeed acknowledged that the amendments submitted by the company, in response to specific Chemistry Manufacturing & Controls information requests, have not been reviewed. However, the CRL also mentioned that specific requirements conveyed during a general inspection of Provention’s manufacturing facility would be resolved before resubmission.
Ashleigh Palmer, Co-founder and Chief Executive of Provention, acknowledged the contributions of employees, consultants, and partners while recognizing patients, their caregivers, study investigators, and clinicians. Palmer also thanked the USFDA’s review team and Dr. Yanoff and Dr. Unger, who worked on the priority review of Teplizumab.