Lumos to advance oral growth hormone therapy into pivotal studies
08 Nov 2023
Phase 2Clinical Result
Lumos Pharma plans to start a Phase III programme for its oral growth hormone therapy LUM-201 in the second half of next year having reported success in a pair of mid-stage trials. “Results…have provided us with clear proof of concept that oral LUM-201 has the potential to serve as a viable alternative to injectable therapies in moderately growth hormone deficient patients,” remarked CEO Rick Hawkins.
The Phase II OraGrowtH210 study included 82 participants diagnosed with moderate paediatric growth hormone deficiency (PGHD) and investigated three different daily dose levels of LUM-201 compared to daily injections of recombinant human growth hormone (rhGH). Lumos noted that the trial hit all primary and secondary endpoints with the mid-level dose of LUM-201 demonstrating annualised height velocity (AHV) of 8.2 cm/year at six months and 8.0 cm/year at 12 months on treatment.
According to the company, these results are in line with historical data in moderate PGHD patients and within the targeted 2 cm/year margin of the comparator injectable rhGH arm, where AHV was 10 cm/year at six months and 9.7 cm/year at 12 months. Meanwhile, the second Phase II study, dubbed OraGrowtH212, confirmed that LUM-201’s pulsatile mechanism produces an increase in growth rates while restoring growth hormone secretion and IGF-1 to within normal ranges, with levels substantially below those produced by exogenous injectable rhGH.
Ron Rosenfeld, who serves as the chairman of Lumos’ clinical and scientific advisory board, remarked “demonstrating the ability to achieve expected growth with oral LUM-201 while exposing patients to only 20% of the growth hormone compared to daily rhGH injections is a significant scientific breakthrough that has the potential to revolutionise the approach to treating children with moderate growth hormone deficiency."
Shares in Lumos jumped as much as 117% in after-market trading on the news. Ahead of the read-out, analysts at HC Wainwright suggested that if LUM-201 shows non-inferiority to injectable rhGH in a pivotal study, then the drug could garner a large share of the market, projecting sales of $73 million in 2027, rising to $221 million in 2028.
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