The cell therapy specialist ReNeuron Group PLC (LON:RENE) is gearing up for a busy 18 months with read-outs from two clinical trials expected in that time-frame.
Patient screening and enrolment have commenced for its most advanced programme, a CTX therapy for stroke, which is entering phase IIb clinical trials, with top-line data from the US study expected in early 2020.
At the same time, ReNeuron’s scientists have optimised the dosing for the company’s hRPC drug for an eye condition called retinitis pigmentosa and a phase I/II assessment has restarted. The initial read-out is expected by the middle of next year.
Focus on drug delivery
The lead candidate from the company’s exosome platform will be developed as a drug delivery vehicle, “providing greater scope for potential near-term partnering deals”, the group told investors.
The update was provided alongside half-year results which showed the company made a loss of £5.3mln, down from £9.6mln a year earlier, while consuming around £7.5mln in cash (2017: £9.2mln).
More importantly, ReNeuron has funds enough to achieve its immediate ambitions. As at the end of September it had £30.7mln in the bank.
Chief executive Olav Hellebø said: "We have continued to maintain tight control over our operating costs, reflected in the financial statements for the period.
“Our cash position remains robust and we are positioned to deliver significant clinical milestones in our stroke and retinitis pigmentosa programmes over the next 18 months."
The company’s CTX stem cell therapy is designed initially to treat people who have suffered an ischaemic stroke and have been left disabled by it. They make up around a half of all stroke survivors.
The treatment consists of a neural stem cell line, which has been generated using the company’s cell expansion and selection technologies and then taken through a full manufacturing scale-up and quality-testing process.
ReNeuron’s human retinal progenitor cell (hRPC) programme for blindness-causing diseases of the retina is partnered with the Schepens Eye Research Institute Massachusetts Eye and Ear, which is an affiliate of Harvard Medical School.
The programme is currently focused on two inherited retinal diseases: retinitis pigmentosa and cone-rod dystrophy, hereditary diseases of the eye that lead to progressive loss of vision due to cells in the retina becoming damaged and eventually dying.
Boss Hellebo said: "Our therapeutic development programmes have continued to progress well during the period. We are particularly excited to have opened the placebo-controlled phase IIb clinical trial in the US for CTX in chronic stroke disability.
“We remain encouraged by the progress made in partnering discussions across all of our technologies and programmes and we hope to be able to conclude an initial out-licensing agreement in the near term.”
The shares were changing hands for 54p, up 4% on the day.