{"id":389426,"date":"2020-11-30T08:03:36","date_gmt":"2020-11-30T13:03:36","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=389426"},"modified":"2020-11-30T08:03:36","modified_gmt":"2020-11-30T13:03:36","slug":"allena-pharmaceuticals-announces-initial-data-from-phase-1-trial-of-alln-346","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/allena-pharmaceuticals-announces-initial-data-from-phase-1-trial-of-alln-346\/","title":{"rendered":"Allena Pharmaceuticals Announces Initial Data from Phase 1 Trial of ALLN-346"},"content":{"rendered":"
\n

— Single-Ascending Doses of<\/em>ALLN-346 <\/em>Oral Enzyme <\/em>Well-Tolerated <\/em>—
<\/em>— <\/em>Non-<\/em>A<\/em>bsorption o<\/em>f <\/em>ALLN-346 <\/em>Demonstrated<\/em> —
<\/em>— <\/em>Advancing <\/em>to <\/em>Phase 1b <\/em>Multiple<\/em>–<\/em>Ascending Dose <\/em>Study <\/em>and <\/em>Phase 2 Proof-of-Concept Trial<\/em>; Initial Data <\/em>from Both Studies <\/em>Expected <\/em>in <\/em>Second <\/em>Half of 2021<\/em> —<\/em><\/p>\n

NEWTON, Mass., Nov. 30, 2020 (GLOBE NEWSWIRE) — Allena Pharmaceuticals, Inc. (NASDAQ: ALNA), a late-stage, biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders, today announced clinical data from its Phase 1 trial of ALLN-346 in healthy volunteers. ALLN-346 is an investigational, orally administered, novel urate-degrading enzyme that has been designed for activity and stability in the gastrointestinal (GI) tract, and is intended for the treatment of hyperuricemia in patients with gout and chronic kidney disease (CKD).<\/p>\n

The double-blind, placebo-controlled, single-ascending dose study enrolled 24 healthy volunteers. Groups of eight study participants were randomized 3:1 to ALLN-346 or matching placebo in three sequential cohorts dosed orally with three, six, or 12 capsules in one day. Each capsule of ALLN-346 contained a target dose of 90 mg of enzyme, equivalent to 2,250 units. ALLN-346 was well-tolerated with no clinically significant safety signals and no dose-limiting toxicities observed in any cohort up to the highest administered dose. In addition, assay of serum samples by ELISA immunoassay demonstrated that ALLN-346 was not absorbed systemically, supporting that its mechanism of action appears to be restricted to the GI tract.<\/p>\n

\u201cWe are very encouraged by the preliminary safety and tolerability data collected for ALLN-346 in healthy volunteers,\u201d said Louis Brenner, M.D, President and Chief Executive Officer of Allena. \u201cWhile there are several classes of approved therapies to treat hyperuricemia and gout, all have significant limitations in the CKD population due to toxicity-related concerns, dose limitations, and contraindications. We specifically designed ALLN-346 to overcome these challenges, using our proprietary platform to create a stable oral enzyme that is intended to act via the gut-kidney axis, degrading urate in the GI tract and reducing the systemic and metabolic burden of urate on the kidneys. The results announced today support our belief in ALLN-346\u2019s gut-restricted mechanism of action and support its further development as a scientifically-driven therapeutic candidate for the approximately 375,000 people living with gout and moderate-to-severe CKD. We are now preparing to advance ALLN-346 into separate Phase 1b multiple-ascending dose and Phase 2 clinical studies, and look forward to further progress, including potential proof-of-concept data, in 2021.\u201d<\/p>\n

Subject to feedback from the U.S. Food and Drug Administration, Allena expects to initiate a Phase 1b multiple-ascending dose trial in healthy volunteers and a Phase 2 proof-of-concept trial in patients with hyperuricemia and CKD in the first half of 2021, with initial data from both studies expected in the second half of 2021.<\/p>\n

\n About Hyperuricemia<\/strong>
\n
Hyperuricemia, or elevated levels of uric acid in the blood, results from overproduction or insufficient excretion of urate, or often a combination of the two. Hyperuricemia is associated with gout, a kind of arthritis caused by excess uric acid in the blood that leads to the formation of hard crystals in the joints. Hyperuricemia can also lead to increased uric acid excretion in the urine and subsequently to kidney stone formation and kidney damage also known as urate nephropathy. In addition, hyperuricemia has been linked to hypertension, CKD, glucose intolerance, dyslipidemia, insulin resistance and obesity.<\/p>\n

CKD patients with hyperuricemia and gout are often not optimally managed due to limitations of available therapies, including decreased tolerability, dose restrictions, drug-drug interactions, and contraindications. According to a published study, there are approximately 375,000 patients in\u00a0the United States\u00a0with hyperuricemia and CKD on urate lowering therapy who have uncontrolled gout.1<\/sup><\/p>\n

_______________
1<\/sup> Lim, J., Fu, A., Reasner, D. & Taylor, D. (2017, April).\u00a0Prevalence of CKD and Uncontrolled Gout Among US Adults: Results From NHANES 2007\u20132012<\/em>. Poster presented at the\u00a0National Kidney Foundation\u00a0Spring Clinical Meetings,\u00a0Orlando, FL.<\/p>\n

\n About ALLN-346<\/strong>
\n
ALLN-346 is an investigational, orally administered, novel, engineered urate oxidase that has been optimized for stability in the GI tract and high production yield. Allena has designed ALLN-346 to degrade urate in the GI tract and in turn, reduce the urate burden on the kidney and lower the risk of urate-related complications. ALLN-346 is targeted to lower serum uric acid in patients with CKD, whose renal function is decreased and who have diminished capacity for urinary excretion of uric acid.<\/p>\n

\n About Allena Pharmaceuticals<\/strong>
\n
Allena Pharmaceuticals, Inc.\u00a0is a late-stage biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders. Allena\u2019s lead product candidate, reloxaliase, is currently being evaluated in a pivotal Phase 3 clinical program for the treatment of enteric hyperoxaluria, a metabolic disorder characterized by markedly elevated urinary oxalate levels and commonly associated with kidney stones, chronic kidney disease and other serious kidney disorders. Allena is also developing ALLN-346 for the treatment of hyperuricemia in the setting of gout and advanced chronic kidney disease, with a Phase 1b multiple-ascending dose study and a Phase 2 proof-of-concept study planned for 2021.<\/p>\n

\n Forward-Looking Statements<\/strong>
\n
This release contains \u201cforward-looking statements\u201d within the meaning of the Private Securities Litigation Reform Act of 1995 including, without limitation, statements regarding the clinical data from Allena\u2019s Phase 1 trial of ALLN-346; Allena\u2019s future development plans for ALLN-346; Allena\u2019s pipeline of oral enzyme therapeutic candidates and Allena\u2019s plans to build a commercial organization. Any\u00a0forward-looking statements\u00a0in this press release are based on management\u2019s 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\u00a0forward-looking statements. These risks and uncertainties include, but are not limited to: market and other conditions,\u00a0the timing for completion of Allena\u2019s clinical trials of its product candidates,\u00a0risks associated with obtaining, maintaining and protecting intellectual property; risks associated with Allena\u2019s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; the risk of competition from other companies developing products for similar uses; risk associated with Allena\u2019s financial condition and its need to obtain additional funding to support its business activities, including the future clinical development of reloxaliase and its ability to continue as a going concern; risks associated with Allena\u2019s dependence on third parties; and risks related to the COVID-19 coronavirus. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Allena\u2019s actual results to differ from those contained in the\u00a0forward-looking statements, see the section entitled \u201cRisk Factors\u201d in Item 1A of Part I of Allena\u2019s Quarterly Report on\u00a0Form\u00a010-Q\u00a0for the quarter ended\u00a0September 30, 2020, as well as discussions of potential risks, uncertainties and other important factors in Allena\u2019s subsequent filings with the\u00a0Securities and Exchange Commission. All information in this press release is as of the date of the release, and Allena undertakes no duty to update this information unless required by law.<\/p>\n

\n Investor Contact<\/strong>
\n
Hannah Deresiewicz
Stern Investor Relations, Inc.
212-362-1200
hannah.deresiewicz@sternir.com<\/a><\/p>\n

\n Media Contact<\/strong>
\n
Adam Daley
Berry & Company Public Relations
212-253-8881
adaley@berrypr.com<\/a><\/p>\n


\n
\n \n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

— Single-Ascending Doses ofALLN-346 Oral Enzyme Well-Tolerated —— Non-Absorption of ALLN-346 Demonstrated —— Advancing to Phase 1b Multiple–Ascending Dose Study and Phase 2 Proof-of-Concept Trial; Initial Data from Both Studies Expected in Second Half of 2021 — NEWTON, Mass., Nov. 30, 2020 (GLOBE NEWSWIRE) — Allena Pharmaceuticals, Inc. (NASDAQ: ALNA), a late-stage, biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders, today announced clinical data from its Phase 1 trial of ALLN-346 in healthy volunteers. ALLN-346 is an investigational, orally administered, novel urate-degrading enzyme that has been designed for activity and stability in the gastrointestinal (GI) tract, and is intended for the treatment of hyperuricemia in patients … <\/p>\n

Continue reading “Allena Pharmaceuticals Announces Initial Data from Phase 1 Trial of ALLN-346”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-389426","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nAllena Pharmaceuticals Announces Initial Data from Phase 1 Trial of ALLN-346 - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/allena-pharmaceuticals-announces-initial-data-from-phase-1-trial-of-alln-346\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Allena Pharmaceuticals Announces Initial Data from Phase 1 Trial of ALLN-346 - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"— Single-Ascending Doses ofALLN-346 Oral Enzyme Well-Tolerated —— Non-Absorption of ALLN-346 Demonstrated —— Advancing to Phase 1b Multiple–Ascending Dose Study and Phase 2 Proof-of-Concept Trial; Initial Data from Both Studies Expected in Second Half of 2021 — NEWTON, Mass., Nov. 30, 2020 (GLOBE NEWSWIRE) — Allena Pharmaceuticals, Inc. (NASDAQ: ALNA), a late-stage, biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders, today announced clinical data from its Phase 1 trial of ALLN-346 in healthy volunteers. 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