Dr. Johnson Brings Extra Than 25 Years of Expertise in Creating and Implementing World Regulatory and Medical Growth Methods from Preclinical By Product Approval

BOSTON, Nov. 09, 2020 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc. (Nasdaq: INZY), a uncommon illness biopharmaceutical firm creating novel therapeutics for the therapy of ailments of irregular mineralization impacting the vasculature, delicate tissue and skeleton, at present introduced the appointment of Kevin B. Johnson, Ph.D., MBA, as senior vice chairman, regulatory affairs, efficient instantly.

Dr. Johnson brings to Inozyme greater than 25 years of expertise in creating and implementing world regulatory and medical improvement methods for uncommon ailments throughout whole product improvement lifecycles from preclinical by way of medical improvement and finally to product approval for a wide range of medicine, biologics, mixture merchandise and cell/gene therapies. Dr. Johnson might be answerable for main Inozyme’s world regulatory technique.

“We’re thrilled to have Kevin be a part of the Inozyme management workforce throughout this era of regular execution and as we put together to enter medical improvement,” mentioned Axel Bolte, MSc, MBA, co-founder, president and chief government officer of Inozyme Pharma. “Kevin is a gifted regulatory affairs government with deep expertise in uncommon ailments and I sit up for Kevin’s contributions in serving to Inozyme meet the wants of underserved affected person communities.”

Dr. Johnson joins Inozyme from Magenta Therapeutics, Inc., the place he served because the senior vice chairman, head of regulatory and high quality, and led world technique for a portfolio of biologics. Previous to that, he served as senior vice chairman, head of regulatory affairs, high quality and pharmacovigilance at IMARA Inc., throughout which period the corporate acquired a number of regulatory designations for orphan ailments corresponding to sickle cell illness and beta-thalassemia. Earlier than IMARA, Dr. Johnson led world regulatory methods at Vtesse (later acquired by Sucampo), addressing ultra-rare ailments corresponding to Niemann-Decide illness sort C underneath Breakthrough Remedy designation from the U.S. Meals and Drug Administration (FDA) and Promising Progressive Medication designation from the UK’s Medicines and Healthcare merchandise Regulatory Company (MHRA). Dr. Johnson additionally served because the director, world regulatory affairs for uncommon ailments and gene therapies at GlaxoSmithKline, engaged on the worldwide regulatory workforce for the European approval of the gene remedy Strimvelis® for ADA-SCID, and which workforce subsequently acquired Regenerative Medication Superior Remedy (RMAT) designation for a retinal gene remedy product.

“Based mostly on the compelling science and preclinical analysis carried out with INZ-701, Inozyme has the potential to assist sufferers with devastating and debilitating uncommon metabolic ailments who at present lack efficient therapy choices,” mentioned Dr. Johnson. “I’m excited to hitch Inozyme at such an vital time within the firm’s development trajectory, and I sit up for contributing to Inozyme’s success.”

Dr. Johnson holds a Ph.D. in Neurobiology from the College of North Carolina College of Medication, an MBA from the Kenan-Flagler College of Enterprise on the College of North Carolina, and a B.S. in Chemistry from the College of South Florida. Dr. Johnson additionally holds a Regulatory Affairs Certification (RAC) credential from the Regulatory Affairs Skilled Society.

About Inozyme Pharma

Inozyme Pharma is a uncommon illness biopharmaceutical firm creating novel therapeutics for the therapy of ailments of irregular mineralization impacting the vasculature, delicate tissue and skeleton. By our in-depth understanding of the organic pathways concerned in mineralization, we’re pursuing the event of therapeutics to deal with the underlying causes of those debilitating ailments. It’s properly established that two genes, ENPP1 and ABCC6, play key roles in a essential mineralization pathway and that defects in these genes result in irregular mineralization. We’re initially targeted on creating a novel remedy to deal with the uncommon genetic ailments of ENPP1 and ABCC6 deficiencies.

Inozyme Pharma was based in 2017 by Joseph Schlessinger, Ph.D., Demetrios Braddock, M.D., Ph.D., and Axel Bolte, MSc, MBA, with know-how developed by Dr. Braddock and licensed from Yale College. For extra data, please go to www.inozyme.com.

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Statements on this press launch about future expectations, plans and prospects, in addition to another statements concerning issues that aren’t historic details, might represent “forward-looking statements” throughout the which means of The Personal Securities Litigation Reform Act of 1995. These statements embody, however will not be restricted to, statements referring to our analysis and improvement packages. The phrases “anticipate,” “consider,” “proceed,” “might,” “estimate,” “anticipate,” “intend,” “might,” “plan,” “potential,” “predict,” “venture,” “ought to,” “goal,” “will,” “would” and related expressions are supposed to determine forward-looking statements, though not all forward-looking statements comprise these figuring out phrases. Any forward-looking statements are primarily based on administration’s present expectations of future occasions and are topic to numerous dangers and uncertainties that might trigger precise outcomes to vary materially and adversely from these set forth in, or implied by, such forward-looking statements. These dangers and uncertainties embody, however will not be restricted to, dangers related to the Firm’s potential to efficiently resolve the medical maintain with regard to its deliberate Part half of medical trial of INZ-701 for ENPP1 deficiency; get hold of and keep needed approvals from the FDA and different regulatory authorities; proceed to advance its product candidates in preclinical research and medical trials; replicate in later medical trials constructive outcomes present in preclinical research and early-stage medical trials of its product candidates; advance the event of its product candidates underneath the timelines it anticipates in deliberate and future medical trials; get hold of, keep and shield mental property rights associated to its product candidates; handle bills; and lift the substantial further capital wanted to attain its enterprise aims. For a dialogue of different dangers and uncertainties, and different vital components, any of which might trigger the Firm’s precise outcomes to vary from these contained within the forward-looking statements, see the “Threat Elements” part, in addition to discussions of potential dangers, uncertainties and different vital components, within the Firm’s most up-to-date filings with the Securities and Trade Fee. As well as, the forward-looking statements included on this press launch signify the Firm’s views as of the date hereof and shouldn’t be relied upon as representing the Firm’s views as of any date subsequent to the date hereof. The Firm anticipates that subsequent occasions and developments will trigger the Firm’s views to vary. Nevertheless, whereas the Firm might elect to replace these forward-looking statements in some unspecified time in the future sooner or later, the Firm particularly disclaims any obligation to take action.

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Brian Luque, Director, Investor Relations

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ir@inozyme.com

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