Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, announces an update on clinical activities.
Phase 2 OraGrowtH210 Trial Primary 6-Month Data Expected 2H2023; Treatment period to be Extended to 12Months
The Company is issuing new guidance concerning the Phase 2 OraGrowtH210 Trial of LUM-201 in PGHD. The pace of site initiation and enrollment of the trial has been slower than anticipated primarily due to COVID-19 restrictions. This impact has been particularly pronounced at international sites where faster patient enrollment was anticipated. Given slower enrollment, the 6-month primary outcome data for OraGrowtH210 are now anticipated in the second half of 2023. The trial's primary outcome continues to be the preliminary validation of our Predictive Enrichment Markers (PEM) strategy. From the trial, we will also select the optimal dose for a pivotal Phase 3 study in PGHD.
Given the novel mechanism of action of LUM-201 compared to other growth hormone therapies, the FDA has now requested an extension of the OraGrowtH210 Trial to 12 months. The planned protocol extension mirrors the first six months of the OraGrowtH211 long-term extension study. The FDA has placed our planned long-term extension study on partial clinical hold until additional efficacy data from the OraGrowtH210 Trial are available to be reviewed. We are currently reviewing the timing of the start of the long-term extension study in context of the OraGrowtH210 Trial extension. We do not anticipate these protocol changes, on a stand-alone basis, to extend the time to the initiation of our Phase 3 clinical trial.
PK/PD OraGrowtH212 Trial of LUM-201 in PGHD Initiated Q2 2021; Treatment Period to be Extended to 12 Months
The OraGrowtH212 Trial was initiated in June and is currently enrolling patients. This study will evaluate the pharmacokinetic and pharmacodynamic (PK/PD) effects of LUM-201 in PGHD patients at two dose levels to confirm prior clinical data illustrating the increased pulsatile release of endogenous growth hormone unique to LUM-201 and its potential for this mechanism of action to contribute to efficacy in PGHD. This open-label trial will be extended from six months to twelve months to capture additional PK/PD and height velocity data. The PD pulsatility assessment will continue to be at six months on therapy as planned.
"While Covid-19 has had an impact on enrollment, as we continue to open international sites for our Phase 2 OraGrowtH210 Trial, we expect the pace of patient screenings to accelerate," commented Rick Hawkins, Chairman, CEO and President of Lumos Pharma. "We look forward to the primary outcome readout of this trial in the second half of 2023. Though the FDA's request for a six-month extension to our OraGrowtH210 Trial was unexpected, we are confident that our trial protocol changes will both add impactful data and meet the FDA's request. We also remain confident in our Predictive Enrichment Markers strategy with respect to our OraGrowtH210 and OraGrowtH212 Trials. Our OraGrowtH212 Trial is up and running and patient enrollment has begun for that trial as well. With a solid financial foundation in place, we believe we have sufficient cash to support operations through the primary outcome readouts for both OraGrowtH210 and OraGrowtH212 Trials."
About Lumos Pharma
Lumos Pharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of therapeutics for rare diseases. Lumos Pharma was founded and is led by a management team with longstanding experience in rare disease drug development and received early funding from leading healthcare investors, including Deerfield Management, a fund managed by Blackstone Life Sciences, Roche Venture Fund, New Enterprise Associates (NEA), Santé Ventures, and UCB. Lumos Pharma's lead therapeutic candidate is LUM-201, an oral growth hormone stimulating small molecule, currently being evalu...
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