AUSTIN, Texas - Lumos Pharma, Inc. (NASDAQ:LUMO), a company specializing in rare disease therapeutics, has been granted a Notice of Allowance for a patent application regarding an oral drug formulation aimed at treating Pediatric Growth Hormone Deficiency (PGHD). The US Patent and Trade Office (USPTO) issued the notice for the company's patent application number PCT/US22/050700, which pertains to the company's LUM-201 drug product.
The patent covers improved formulations of LUM-201, which Lumos Pharma plans to use in its Phase 3 clinical trial and aims to commercialize eventually. The patent is set to extend the intellectual property protection of these formulations through November 2042.
Rick Hawkins (NASDAQ:HWKN), Lumos Pharma's Chairman and CEO, expressed enthusiasm about the patent grant, highlighting the unique properties of LUM-201 achieved through their manufacturing processes. According to Hawkins, the novel formulation will allow for capsules with mini-tablets, designed to reduce dose variance and simplify administration for younger children. The company intends to incorporate this formulation in its upcoming Phase 3 trial for moderate PGHD, expected to commence in Q4 2024, following potential regulatory approval.
LUM-201, also known as ibutamoren, is an orally administered molecule that stimulates the secretion of growth hormone from the pituitary gland. It has been observed to increase the amplitude of endogenous pulsatile GH secretion in humans, a pattern that mimics natural GH secretion. The therapeutic candidate has undergone studies in over 1,300 patients and has been generally well tolerated, with the most common adverse events related to the digestive system, including increased appetite and mild elevations in liver enzymes.
The company, which has a focus on developing and commercializing therapeutics for rare diseases, has received Orphan Drug Designation for LUM-201 in both the US and EU. This designation is granted to drugs intended for the treatment of conditions affecting fewer than 200,000 people in the US.
This news is based on a press release statement from Lumos Pharma, Inc.
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