{"id":524007,"date":"2021-08-05T08:03:49","date_gmt":"2021-08-05T12:03:49","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/lumos-pharma-reports-second-quarter-2021-financial-results-and-provides-clinical-and-corporate-updates\/"},"modified":"2021-08-05T08:03:49","modified_gmt":"2021-08-05T12:03:49","slug":"lumos-pharma-reports-second-quarter-2021-financial-results-and-provides-clinical-and-corporate-updates","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/lumos-pharma-reports-second-quarter-2021-financial-results-and-provides-clinical-and-corporate-updates\/","title":{"rendered":"Lumos Pharma Reports Second Quarter 2021 Financial Results and Provides Clinical and Corporate Updates"},"content":{"rendered":"
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\u2022 Lumos Pharma strengthens leadership team with promotion of John McKew, PhD to President, and addition of David B. Karpf, MD as Chief Medical Officer and Mark Bach, MD, PhD to Advisory Board<\/em><\/p>\n

\n \u2022 Screening and enrollment of OraGrowtH210 and OraGrowtH212 Trials progress <\/em>\n <\/p>\n

AUSTIN, Texas, Aug. 05, 2021 (GLOBE NEWSWIRE) — Lumos Pharma, Inc.<\/a> (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, announced financial results for the second quarter ending June 30, 2021 and provided an update on clinical and corporate activities.<\/p>\n

\u201cThe enhancement of Lumos Pharma\u2019s leadership team and encouraging recent trends in screening and enrollment for both OraGrowtH210 and OraGrowtH212 Trials are exciting developments for the Company,\u201d commented Rick Hawkins, Chairman and CEO of Lumos Pharma. \u201cJohn McKew, David Karpf, and Mark Bach each bring significant clinical development and management expertise to their new roles with the Company, strengthening our ability to execute on our clinical and corporate strategy. The majority of our trial sites are now open, and we continue to work to bring the remainder online. Additionally, as children return to school this fall and regular pediatrician visits resume, we believe these factors should lead to increased referrals and an acceleration of enrollment in our trials.\u201d\u00a0\u00a0<\/p>\n

\n Corporate Update:<\/strong>\n <\/p>\n

\n John McKew, PhD, Chief Operating Officer & Chief Scientific Officer, Promoted to President<\/strong>\n <\/p>\n

Our Chief Operating Officer and Chief Scientific Officer, John McKew, was recently promoted to President of Lumos Pharma effective August 1, 2021 as part of a planned succession process. Dr. McKew has nearly 30 years of experience developing novel therapeutics during which he successfully advanced multiple therapies through preclinical and into clinical development, both at the NIH and in the pharmaceutical industry. Dr. McKew has served as Chief Operating Officer of Lumos Pharma since April 2020 and as Chief Scientific Officer since he joined the Company in 2016.\u00a0\u00a0<\/p>\n

\n David B. Karpf, MD, Experienced Endocrinologist and Pharma Executive, Named Chief Medical Officer <\/strong>\n <\/p>\n

Pharma industry veteran and academician, David B. Karpf, MD, joined Lumos Pharma as Chief Medical Officer on August 3, 2021. Dr. Karpf is an Adjunct Clinical Professor in the Division of Endocrinology at Stanford University School of Medicine with over 35 years of expertise in all aspects of clinical endocrinology. He is also an accomplished executive with 30 years of experience in the development of biopharmaceuticals and small molecular weight drugs in the areas of endocrinology and rare diseases, among others. Most recently, Dr. Karpf served as Vice President, Clinical Development for Ascendis Pharma where he was responsible for several compounds in clinical development, including TransCon GH, long-acting growth hormone for once weekly treatment of growth hormone deficiency, and TransCon PTH. Dr. Karpf has held leadership positions at several biopharmaceutical and pharma companies, including Merck where he originally gained experience with Lumos Pharma\u2019s oral growth hormone secretagogue, LUM-201.\u00a0\u00a0<\/p>\n

\n Pediatric Endocrinologist and Biopharma Executive, Mark Bach, MD, PhD, Joins Advisory Board<\/strong>\n <\/p>\n

Mark Bach, MD, PhD, pediatric endocrinologist and seasoned pharmaceutical executive, joined Lumos Pharma\u2019s Clinical Scientific Advisory Board on July 15, 2021. Dr. Bach is currently the Chief Medical Officer for ShouTi Inc., having recently joined from Ascendis Pharma where he served as Senior Vice President, Endocrine Medical Sciences. Dr. Bach is a pediatric endocrinologist with 30 years of clinical research and pharmaceutical development experience. Prior to Ascendis, Dr. Bach held successive leadership roles in research and development at both Johnson & Johnson and Merck. While at Merck, he conducted extensive clinical and preclinical research on growth hormone, IGF-1 and LUM-201 (MK-0677).<\/p>\n

\n Clinical Update: <\/strong>\n <\/p>\n

\n OraGrowtH210 Trial of LUM-201 in PGHD <\/strong>\n <\/p>\n

As the Company announced on July 21, 2021, given the slower pace of site initiation and enrollment of the Phase 2 OraGrowtH210 Trial of LUM-201 in PGHD primarily due to the impact of \ufeffCOVID, the 6-month primary outcome data for OraGrowtH210 is now anticipated in the second half of 2023. The treatment period for this trial has been extended to 12 months to capture additional data for future regulatory filings and to meet FDA requirements to initiate our proposed 3-year long-term extension study, the OraGrowtH211 Trial. We do not anticipate these protocol changes, on a stand-alone basis, to extend the time to initiation of our Phase 3 clinical trial. The primary outcome for the Phase 2 OraGrowtH210 Trial continues to be the preliminary validity of our Predictive Enrichment Marker (PEM) strategy with the goal of selecting the optimal dose for a pivotal Phase 3 study in PGHD.<\/p>\n

\n PK\/PD OraGrowtH212 Trial of LUM-201 in PGHD Initiated Q2 2021<\/strong>\u00a0\u00a0<\/p>\n

The OraGrowtH212 Trial was initiated in June and is currently enrolling patients.\u00a0\u00a0 This study will evaluate the PK\/PD effects of LUM-201 in PGHD patients at two dose levels, 1.6 and 3.2 mg\/kg\/day, 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 occur at six months on therapy as planned.<\/p>\n

\n Pipeline Expansion <\/strong>\n <\/p>\n

We have been conducting an assessment of the range of disease areas where LUM-201 would have medical utility for purposes of prioritizing our next indication and longer-term life cycle planning. These assessments reinforce our conviction that LUM-201 represents a pipeline-in-a-product and look forward to advancing the next phase of LUM-201 opportunities. In addition, with a heightened sensitivity toward value creation, we continue to evaluate select rare disease assets under consideration to add to our product portfolio.\u00a0\u00a0<\/p>\n

\n Financial Results for the Quarter Ended June 30, 2021 <\/strong>\n <\/p>\n