
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 | |
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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. |