Allena Pharma Tumbles on Positive Study Results

Shares of Allena Pharmaceuticals (NASDAQ:ALNA) crumbled during Thursday’s (November 7) trading session despite the company releasing positive results from two of its clinical trials evaluating its lead drug candidate, reloxaliase.

In a press release, the company said both studies are evaluating reloxaliase in patients with kidney disorders and with enteric hyperoxaluria (EH), which is a fat malabsorption condition.

While the company reported that its URIROX-1 Phase 3 trial met its primary endpoints and preliminary data from Phase 2 Study 206 had a drastic plasma oxalate reduction in EH patients and chronic kidney disease (CKD) patients, Allena’s share price did not respond favorably.

Over the course of Thursday’s trading session, shares of Allena Pharmaceuticals dropped almost 62 percent to close the trading session at US$2.24. After hours trading bumped the company’s share price back up over 11 percent to US$2.50 as of 5:54 p.m. EST.

The URIOX-1 clinical trial evaluated the safety and efficacy of reloxaliase in 115 EH patients with urinary oxalate (UOx) over the course of four weeks. Patients were randomized to receive either reloxaliase or a placebo with food between three and five times per day.

Allena Pharmaceuticals’ Study 206, on the other hand, enrolled patients with EH and advanced CKD. Advanced CKD can result in systemic oxalosis, which is a potentially life-threatening disease. In the study, two patients with stage 3 CKD had a dramatic reduction in UOx excretion between the fourth and 12th week; six patients with stage 5 CKD demonstrated a substantial reduction in plasma oxalate (POx) levels during the same timeframe.

“The demonstration of reloxaliase’s ability to consistently and significantly reduce UOx for patients in URIROX-1, and also reduce (POx) in patients with EH and advanced CKD in Study 206, is an important step in the development of reloxaliase as a potential first-in-class therapy for people living with EH,” Louis Brenner, MD, president and CEO of Allena Pharmaceuticals, said in a press release.

According to Brenner, no treatment options currently exist for these conditions. With topline results from URIROX-1, Brenner said the company can now apply the findings to the development of reloxaliase. Data from ClinicalTrials.gov shows that patient recruitment for the trial is currently underway with the study expected to be completed by January 2023.

He added that, thanks to the reduction of POx in its Study 206, the company will also consider exploring “a registrational path for reloxaliase as a potential treatment for patients with EH and advanced CKD.”

In addition to Thursday’s announcement, the company said data from both URIROX-1 and Study 206 will be presented in Washington, DC, at the ASN Annual Meeting on November 8 and 9.

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Securities Disclosure: I, Jocelyn Aspa, hold no direct investment interest in any company mentioned in this article.