Reneuron crashes out of retinitis pigmentosa

Reneuron had hoped to reinvent itself as a retinitis pigmentosa player, backed by phase 2 data in a handful of patients. Now this chapter of the company’s history has come to a sorry end, after disappointing results in more subjects spurred the group to deprioritise its human retinal progenitor cells (hRPCs). Seven patients treated with a high dose of two million cells had “very limited efficacy”, while surgical complications also caused concern. Signs are not great for the low dose, one million cells, either: the group had previously disclosed a 9.9-letter improvement in visual acuity among seven evaluable patients at one year, but said today that the effect waned thereafter. Reneuron believes that a new phase 2 trial of the low dose could pinpoint subgroups of patients with a higher and more durable response, but is looking to license the asset out. Whether anyone will bite is another matter, although Jcyte signed a $50m ex-US deal with Santen in 2020 despite its stem cell project, jCell, flunking a phase 2b study. Jcyte says it has found a suitable population for its pivotal trial. Reneuron, meanwhile, will focus on its exosome technology, but unimpressed investors sent its stock down 38% this morning.

The rise and fall of Reneuron's hRPCs in retinitis pigmentosa
Date Event
Feb 2019 Promising data from first 3 pts receiving 1m cell dose in phase 1/2 trial (Reneuron eyes a partner with new stem cell data, February 20, 2019)
Oct 2019 Data in 8 pts receiving 1m cell dose disappointed; 2 pts had procedure-related vision loss (Reneuron’s reinvention falters, October 2, 2019)
Jun 2020 Regulatory approval to expand study to include higher 2m cell dose
Nov 2020 Data showing 9.9-letter improvement in 7 pts receiving 1m cell dose at 12 months (incl pts with successful surgical procedure only)
Jun 2021 Study put on hold to investigate presumed case of bacterial endophthalmitis in pt receiving 2m cell dose
Oct 2021 Regulatory approval to restart study
Jan 2022 "Limited efficacy" in 7 pts receiving 2m cell dose, plus waning effect after 12 months in 7 pts receiving 1m cell dose; Reneuron to seek licensing partners
Source: company releases.

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