8-K

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On July 19, 2022, Inozyme Pharma, Inc. (the “Company”) issued a press release announcing preliminary biomarker, safety and pharmacokinetic (“PK”) data from the 0.2 mg/kg dose cohort of the Company’s ongoing Phase 1/2 clinical trial of INZ-701 in adult subjects with ABCC6 Deficiency, which presents as pseudoxanthoma elasticum (“PXE”) in older individuals. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information in this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

On July 19, 2022, the Company announced preliminary biomarker, safety and PK data from the 0.2 mg/kg dose cohort of the Company’s ongoing Phase 1/2 clinical trial of INZ-701 in adult subjects with ABCC6 Deficiency, which presents as PXE in older individuals.

At the 0.2 mg/kg dose level of INZ-701, all three subjects showed rapid and significant increases in plasma pyrophosphate (“PPi”) levels. In preclinical models, PPi was shown to be a key predictive biomarker of therapeutic benefit in ABCC6 Deficiency.

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The mean PPi level across the three subjects at baseline was 851 nM.

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The mean PPi level during the 32-day dose evaluation period across the three subjects was 1057 nM, which was within the range (1002-2169 nM) observed in the Company’s study of healthy subjects (n=10).

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Among the three subjects, the range of peak PPi levels observed during the 32-day dose evaluation period was 2139-4090 nM.

Preliminary PK and INZ-701 enzymatic activity remained consistent with data previously reported from the Company’s ongoing Phase 1/2 trial of INZ-701 in subjects with ENPP1 Deficiency. INZ-701 continued to exhibit a favorable initial safety profile. INZ-701 was generally well-tolerated with no serious adverse events reported, one grade 1 adverse event (“AE”), and no injection site reactions. The grade 1 AE was not related to INZ-701. Low titers of anti-drug antibodies were observed in one subject at day 32 of the trial, which had no impact on PK or ENPP1 activity. All three subjects from the first cohort enrolled in the open-label Phase 2 48-week extension portion of the trial.

Following the planned review of these preliminary data by a data safety monitoring board, the Company expects to initiate dosing in the next dose cohort (0.6 mg/kg) in this trial in the third quarter of 2022. The Company plans to report topline data from the ongoing Phase 1/2 clinical trial in ABCC6 Deficiency in the first quarter of 2023.

Statements in this Current Report on Form 8-K about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to trial results, trial design, trial enrollment, trial dosing, the availability of clinical trial data and the potential benefits of INZ-701. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with the Company’s ability to conduct its ongoing Phase 1/2 clinical trials of INZ-701 for ENPP1 Deficiency and ABCC6 Deficiency; obtain and maintain necessary approvals from the FDA and other regulatory authorities; continue to advance its product candidates in preclinical studies and clinical trials; replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; advance the development of its product candidates under the timelines it anticipates in planned and future clinical trials; obtain, maintain and protect intellectual property rights related to its product candidates; manage expenses; and raise the substantial additional capital needed to achieve its business objectives. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section in the Company’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties and other important factors, in the Company’s most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this Current Report on Form 8-K represent the Company’s views as of the date hereof and should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


Exhibit No.		Description

99.1		Press Release, dated July 19, 2022

104		Cover Page Interactive Data File (formatted as Inline XBRL)


	INOZYME PHARMA, INC.
Date: July 19, 2022	By:	/s/ Axel Bolte
		Name: Axel Bolte
		Title: President and Chief Executive Officer


☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


Item 7.01 Regulation FD Disclosure.


Item 8.01 Other Events.


Item 9.01 Financial Statements and Exhibits.