Allena Pharmaceuticals Provides Updates on Reloxaliase Development Program and Corporate Activities

– Prioritizing Development of Reloxaliase for Patients with Enteric Hyperoxaluria (EH) –

– Plan to Re-Engage with U.S. Food and Drug Administration (FDA) to Evaluate Opportunities to Streamline URIROX-2, Second Pivotal Phase 3 Trial of Reloxaliase in EH –

– Implementing Measures to Reduce Expenses and Preserve Capital for Reloxaliase Programs –

NEWTON, MA, USA I December 04, 2019 I 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 updates on its clinical development programs for reloxaliase, a potential first-in-class, non-absorbed, orally administered enzyme for the treatment of severe hyperoxaluria, and several initiatives to realign resources to support the continued development of reloxaliase for patients with enteric hyperoxaluria (EH).

Following positive topline results from URIROX-1 and further analysis of the data from the trial, Allena plans to re-engage with the FDA, with the request to discuss measures to potentially streamline its ongoing URIROX program through modifications to the adaptive URIROX-2 trial design. These enhancements could potentially include reducing the target enrollment in URIROX-2, conducting an earlier interim analysis of the data from URIROX-2, and modifying the requirements for filing for accelerated approval of the initial reloxaliase Biologics Licensing Application (BLA). The company expects to meet with the FDA in early 2020 and to provide an update on the final design and timing of the URIROX-2 study as it evolves.

“We continue to be encouraged by the pivotal Phase 3 URIROX-1 results and are committed to advancing reloxaliase as the first potential approved treatment for patients with EH,” said Louis Brenner, M.D., President and Chief Executive Officer of Allena Pharmaceuticals. “Reloxaliase achieved its primary endpoint in URIROX-1, demonstrating a statistically significant and clinically meaningful reduction in urinary oxalate (UOx). Based on the positive feedback that we continue to receive from key opinion leaders and clinicians and the severity of the condition in our trial population, we are confident that reloxaliase has the potential to alter the treatment landscape for patients with EH, and offer treating physicians an important new tool for combating the toxic accumulation of excess oxalate in patients with gastrointestinal (GI) disorders. We look forward to initiating discussions with the FDA in the near-term, as we consider opportunities to streamline the URIROX-2 program and expeditiously deliver reloxaliase to patients.”

Allena is implementing several measures in order to preserve capital and focus its resources on its reloxaliase programs, while maintaining key product development and corporate capabilities:

  • The company will limit the opening of new trial sites for its ongoing URIROX-2 trial and continue to enroll patients at existing sites, until further clarity from the FDA is received regarding potential changes to the URIROX program.
  • The company will delay additional planned investments in manufacturing.
  • The company will implement a reduction in its workforce that will lead to an approximately 30 percent reduction in salary and related compensation expenses.

Allena also remains focused on completing its ongoing Study 206 in patients with EH and advanced chronic kidney disease (CKD). Based on the results of the study and the severity of the condition, the company plans to interact with regulatory agencies in the first quarter of 2020 to discuss the registrational path, including expedited options, for reloxaliase in high-risk EH patients with CKD. Additionally, Allena remains on track to file an investigational new drug (IND) application for ALLN-346, a novel urate-degrading enzyme, this quarter, though first-in-human studies will be pursued only once additional financial resources are secured.

With these measures in place, Allena expects that its current cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2020.  The company also continues to explore a range of potential financial alternatives to support the development of reloxaliase, including potential financing transactions and business development partnerships.

Dr. Brenner added: “We remain conscious of the additional resources we need to advance reloxaliase through our URIROX program. To that end, we have made the difficult decision to realign our investments and internal resources to provide us with resources to enable us to focus on, and execute against, our strategy of delivering reloxaliase for the treatment of patients across the spectrum of EH. Unfortunately, this will impact a number of our highly talented and dedicated employees. We are incredibly grateful to those who are affected by this decision, and deeply appreciative of all of their hard work to support our development of novel therapies for patients with rare and severe metabolic disorders.”

About Allena Pharmaceuticals
Allena Pharmaceuticals, Inc. is 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’s lead product candidate, reloxaliase, is a first-in-class, oral enzyme therapeutic for the treatment of 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.

SOURCE: Allena Pharmaceuticals

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