Provention’s diabetes project takes a tentative step forward

Snippets

A 10-7 advisory committee vote in favour of approving teplizumab to delay the onset of type 1 diabetes is a step in the right direction for Provention’s project. But it is far from the end of the road. For a start there are FDA concerns about pharmacokinetic inconsistencies between the MAb used in the clinic and the one Provention plans to take to market; regardless of the agency's opinion on approvability, the issue is thought likely to result in the July 2 Pdufa date being missed. Other concerns raised by the panel included the small sample size, with only 44 patients receiving teplizumab, and lack of long-term safety data. The panellists and the FDA seem to agree that a 32.5-month delay in median time to clinical diagnosis is meaningful, but it is easy to see why the agency might choose to tread cautiously here. Another aspect troubling investors is the commercial potential of this opportunity, which in the short term would be hampered by the lack of effective ways to identify at-risk people, outside of having close relatives with the disease. The harsh realities facing Provention won out this morning, with the stock opening off 14%.

Teplizumab in type 1 diabetes: a long development history
Year  Event Note 
2002 Ph1 data on teplizumab in new-onset type 1 diabetes reported in NEJM Trial finds improvement in metabolic control and mitigation of deterioration of insulin production
2005 Macrogenics buys teplizumab from Tolerance Therapeutics Terms undisclosed
2005 NIAID starts the Abate trial of teplizumb to halt the progression of newly diagnosed type 1 diabetes Study finds that teplizumab significantly reduced the loss of C-peptide after two years (p=0.002) but responses vary widely
2007 Macrogenics starts the Protégé Study in newly diagnosed type 1 diabetics -
2007 Lilly buys global rights to teplizumab Terms include $41m up-front fee and up to $450m in milestones, plus royalties
2010 NIDDK starts the "At risk" trial, or TN-10 -
2010 Protégé fails to meet primary endpoint of lowering insulin use and HbA1c Macrogenics and Lilly ultimately abandon the project
2018 Provention buys teplizumab from Macrogenics Terms include a warrant to buy 2.2 million shares at $2.50 (exercised in 2019); plus $170m on regulatory milestones, incl $60m on FDA approval, plus $250m sales milestones and single-digit royalties
2019 Provention starts the Protect trial in recently diagnosed type 1 diabetics Topline data data due in H1 2023
2019 TN-10 succeeds, extending diabetes diagnosis by two years. Provention announces plans to file teplizumab for approval
2021 Provention files teplizumab for US approval  -
2021 FDA adcom votes 10-7 in favour of approving teplizumab to delay type 1 diabetes. -
July 2, 2021 Pdufa date -
Source: Evaluate Pharma, company statements & SEC filings. 

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