Inozyme Pharma Inc (NASDAQ: INZY) has started 2023 off with a bang rocketing up over $6 on Friday, a key resistance point, before a pullback after the biotech recently reported positive topline and safety data in presently ongoing Phase 1/2 trials of INZ-701, the Company’s drug being evaluated for the treatment of ENPP1 deficiency and ABCC6 deficiency (PXE). Using tech licensed from Yale University and with a string of biopharma executives and Big Pharma venture backers including Longitude Capital, New Enterprise Associates, Novo Ventures and Sanofi Venture, Inozyme Pharma is well-positioned moving forward with the recent release of positive topline data for INZ-701 in the ongoing ENPP1 Deficiency and ABCC6 Deficiency trials, the planned initiation of pivotal trials this year, and a strong cash balance of 127.9 million. Management seems especially optimistic here with director Robert Hopfner acquiring over $2 million in INZY well over current market prices  

Inozyme went public during the summer of 2020 quickly rocketing to highs over $30 per share followed by several years of steady losses that culminated in INZY hitting all-time lows of $0.99 in December. In 2023 INZY has made a powerful reversal northbound recently hitting $6.20 per share. For INZY $6 is an important established support/resistance level; another solid break over $6 and INZY could really take off. Inozyme has big plans in 2023 starting with the initiating the ENERGY-1 – Phase 1b clinical trial to evaluate the safety, tolerability, PK and PD of INZ-701 in infants, Interim clinical data from ongoing Phase 1/2 trial in adults,  Initiation of pivotal trial in pediatric patients, subject to regulatory approval, Start of European Medicines Agency protocol assistance meetings and the Interim clinical data from ongoing Phase 1/2 trial in adults expected to begin in Q4 2023. We will be updating on INZY when more details emerge so make sure you are subscribed to newsytrends.com by entering your email below.

Inozyme Pharma Inc (NASDAQ: INZY) operating out of Cambridge, Massachusetts is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases impacting the vasculature, soft tissue, and skeleton. The Company is developing INZ-701, an enzyme therapy, to address pathologic mineralization and intimal proliferation which can drive morbidity and mortality in these severe diseases. INZ-701 is currently in Phase 1/2 clinical trials for the treatment of ENPP1 Deficiency and ABCC6 Deficiency.  

ENPP1 and ABCC6 Deficiencies are chronic, systemic, and progressive diseases that represent a significant unmet medical need, with high mortality rates. There are currently no approved therapies for either ENPP1 Deficiency or ABCC6 Deficiency. ABCC6 Deficiency is a systemic and progressively debilitating condition, which Isozyme believes affects more than 67,000 individuals worldwide.   

Inozyme Pharma’s lead product candidate, INZ-701, is a soluble, recombinant, genetically engineered, fusion protein that is designed to correct a defect in a pathway involving ENPP1 and ABCC6 Deficiencies. This pathway is central to the regulation of calcium deposition throughout the body and is further associated with the inhibition of intimal proliferation or narrowing and obstruction of blood vessels. Inozyme has generated robust proof of concept data in preclinical models demonstrating that INZ-701 prevented pathological calcification and skeletal abnormalities, led to improvements in overall health and survival and prevented intimal proliferation. INZ-701 is designed to increase circulating levels of plasma pyrophosphate, or PPi, and adenosine. In preclinical studies conducted in Enpp1-deficient mouse models, dosing with INZ-701 resulted in increased plasma PPi levels, prevention of calcification in the heart, aorta, kidney, liver, spleen and lung, prevention of skeletal abnormalities and improvements in overall health. In Abcc6-deficient mouse models, dosing with INZ-701 also increased plasma PPi levels and prevented calcification in key tissues. In addition to increasing levels of PPi, in preclinical studies, INZ-701 prevented intimal proliferation in both wild-type and Enpp1-deficient mice, which we believe is attributable to increased levels of adenosine.  

Inozyme Pharma is currently conducting Phase 1/2 clinical trials of INZ-701 for the treatment of ENPP1 Deficiency and ABCC6 Deficiency. The FDA, and the EMA, have granted orphan drug designation to INZ-701 for the treatment of ENPP1 Deficiency and ABCC6 Deficiency. The FDA has also granted fast track designation for INZ-701 for the treatment of ENPP1 Deficiency, and rare pediatric disease designation for INZ-701 for the treatment of ENPP1 Deficiency.  

In November 2021, Inozyme initiated its Phase 1/2 clinical trial of INZ-701 in ENPP1 Deficiency. The clinical trial initially enrolled nine adult patients with ENPP1 Deficiency at sites in North America and Europe. In February 2023, Inozyme reported topline data from this trial showing a rapid, significant, and sustained increase in PPi in all dose cohorts and in all patients, with a target PPi threshold observed from the lowest dose of 0.2 mg/kg. PPi increased in all patients to levels comparable to those observed in a study of healthy subjects. The drug also has an excellent safety profile with no serious or severe adverse events attributed to INZ-701.  

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Inozyme initiated pivotal trial meetings with the FDA in the first quarter of 2023. The Company plans to initiate a Phase 1b clinical trial of INZ-701, or the ENERGY-1 trial, to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of INZ-701 in infants with ENPP1 Deficiency in the second quarter of 2023. Inozyme is also actively designing a pivotal trial of INZ-701 in pediatric patients with ENPP1 Deficiency and plans to initiate this trial in the third quarter of 2023, subject to receipt of regulatory approval. Inozyme anticipates initiating protocol assistance meetings with the EMA in the fourth quarter of 2023. In February 2023, Inozyme  dosed its first pediatric patient with ENPP1 Deficiency with INZ-701 under our expanded access program.  

In April 2022, Inozyme  initiated a Phase 1/2 clinical trial of INZ-701 in adult patients with ABCC6 Deficiency. The trial initially enrolled nine patients with ABCC6 Deficiency at sites in the United States and Europe. In February 2023, Inozyme reported topline data from this trial. A rapid, significant, and sustained increase in PPi was observed in all cohorts with a dose response observed. PPi showed sustained increase in the highest dose cohort to levels comparable to those observed in its study of healthy subjects. The data was highly encouraging and showed that INZ-701 significantly increased PPi levels into normal physiological ranges with a favorable safety profile and represented strong evidence to warrant continued clinical development of INZ-701 in ENPP1 Deficiency and ABCC6 Deficiency.  

Subject to successfully completing clinical development of INZ-701 in ENPP1 and ABCC6 Deficiencies, Inozyme plans to seek marketing approvals for INZ-701 on a worldwide basis. Beyond the development focus on INZ-701, Inozyme believes its therapeutic approach has the potential to benefit patients suffering from additional diseases of pathologic mineralization and intimal proliferation, including those without a clear genetic basis, such as calciphylaxis or calcifications as a result of end stage kidney disease, or ESKD. In December 2022, the FDA allowed Inozyme IND to enable it to evaluate INZ-701 in a clinical trial in patients with ESKD and calciphylaxis. The Company plans to initiate a clinical trial in ESKD patients. Inozyme  is also exploring the potential for development of a gene therapy for ENPP1 Deficiency.  

Inozyme retains worldwide, exclusive development and commercialization rights to its pipeline and programs, including INZ-701. The Company obtained an exclusive, worldwide license to its foundational intellectual property rights from Yale University in 2019 and acquired its patents related to ENPP1 from Alexion Pharmaceuticals. Inozyme currently owns 22 issued U.S. patents, two pending U.S. provisional patent applications, 18 pending U.S. non-provisional patent applications, 19 issued foreign patents (including three issued European patents), 140 pending foreign patent applications, and three pending Patent Cooperation Treaty applications. Inozyme also owns two U.S. trademark applications, two pending foreign trademark applications, and twelve foreign registered trademarks.  

Inozyme  has assembled a powerful management team. Axel Bolte, the Company’s President and CEO and a co-founder recently retired and Douglas A. Treco, Ph.D took over as CEO on April 1. Dr. Treco was co-founder, president, and chief executive officer of Ra Pharmaceuticals, Inc. (acquired in 2020 by UCB S.A. for $2.5 billion) where he oversaw the discovery and development of zilucoplan in myasthenia gravis, which is currently under review for marketing approval in the United States and European Union. Previously, he co-founded Transkaryotic Therapies, Inc. (TKT; acquired in 2005 by Shire plc.

$INZY 1 year chart ➡️➡️ Big breakout over $6 pivot point pic.twitter.com/4RfdImF0QJ

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Currently trading at a $247 million market valuation INZY os is 43,720,007 shares outstanding as of March 17, 2023. Inozyme Pharma is an exciting story developing in small caps; using tech licensed from Yale University and with a string of biopharma executives and Big Pharma venture backers including Longitude Capital, New Enterprise Associates, Novo Ventures and Sanofi Venture, Inozyme Pharma is well-positioned moving forward with the recent release of positive topline data for INZ-701 in the ongoing ENPP1 Deficiency and ABCC6 Deficiency trials, the planned initiation of pivotal trials this year, and a strong cash balance. INZY has a significant gap to fill from current levels since trading over $30 shortly after its IPO in 2020. 2 weeks ago, Jefferies upgraded its outlook for Inozyme from Hold to Buy. As of March 24, 2023, the average one-year price target for Inozyme Pharma is $19.46 for what its worth, they were also saying that when INZY was $1. We will be updating on INZY when more details emerge so make sure you are subscribed to newsytrends.com by entering your email below.

Disclosure: we hold no position in INZY either long or short and we have not been compensated for this article.