|Reco Pharma Says Trial Study Not Seen Reaching Statistical Significance; FDA Removes Partial Clinical Hold on OncoMed's Ipafricept|
|By Staff and Wire Reports|
|Thursday, 04 September 2014 22:30|
Recro Pharma, Inc. (Nasdaq: REPH), a clinical stage specialty pharmaceutical company developing non-opioid therapeutics for the treatment of pain, initially for acute pain following surgery, announced a clinical strategy update following findings from a prespecified interim analysis conducted on the initial half of patients who completed enrollment in the Company's REC-13-012 trial. The trial is a double blind, placebo-controlled study of intranasal dexmedetomidine, Dex-IN, in the treatment of acute post-operative pain following bunionectomy surgery on Post Op Day 0. While analgesia and a reduction in opioid use were observed in a subset of patients, the study is not expected to reach statistical
significance in its current design. As a result, the Company plans to close this study and launch a revised study starting in Q4 2014. The Company will evaluate Dex-IN 50 mcg versus placebo in management of post-op pain starting Post Op Day 1 after bunionectomy surgery. Note that there were no serious adverse events observed in the REC-13-012 trial.
"There remains a significant unmet medical need for opioid-sparing analgesics, a need which we continue to believe may be addressed with Dex-IN," said Gerri Henwood, Recro Pharma's President and Chief Executive Officer. "Observations from an interim analysis of the REC-13-012 trial, however, suggest that the current study design will not allow us to reach statistical significance for single agent Dex-IN in a bunionectomy pain model starting on Post Op Day 0.
That said, analgesia and corresponding reduction in opioid use, observed in a subset of patients, suggest that Dex-IN may serve as an effective pain management tool in a Post Op Day 1 bunionectomy study model. Based on what we know about the trajectory of pain, together with these observations, which confirm our earlier trial results and demonstrate efficacy for the first time in acute post-op pain, we believe that a study of 50 mcg Dex-IN in a Post Op Day 1 setting is the best path forward."
The interim analysis was based on the primary endpoint, SPID48 (summed pain intensity difference over 48 hours). This preplanned interim analysis was designed to allow for possible sample size adjustment. The results of the interim analysis (n=68, approximately 22 patients per group) revealed that the efficacy of Dex-IN as a stand alone drug was not sufficient to manage severe pain in bunionectomy on post operative day zero, Post Op Day 0. As a result, increased sample size is unlikely to be an effective modification of the
In the interim analysis, the Company observed in patients with baseline pain intensity scores of ≤ 6 (N=34) that pain was more effectively managed on Post Op Day 0, as seen in the separation of scores between Dex-IN 50 mcg and Placebo (Table 1). In addition, based on an understanding of the trajectory of pain, it is recognized that pain on Post Op Day 0 is generally escalating, while pain on Post Op Day 1, or the day after surgery, is generally stable or declining. Based on the input from the Company's advisors, the results of the interim analysis and subset analyses, the information suggests that a post-operative pain management study in patients who initiate study treatment on Post Op Day 1 would be more effective than the current study design .
OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), announced today that the U.S. Food and Drug Administration (FDA) removed the partial clinical hold on the company's ipafricept (FZD8-Fc, OMP-54F28) Phase 1 clinical trials. Enrollment and dosing of new patients is expected to resume within the next few weeks as the study sites' institutional review boards (IRBs) receive and approve the revised trial protocols. Ipafricept is being studied in combination with standard-of-care in three Phase 1b studies.
"With important input from our clinical investigators and academic bone experts, the OncoMed team has developed modified study parameters intended to avoid potential risks while allowing us to evaluate the therapeutic impact of ipafricept for patients with pancreatic, hepatocellular and ovarian cancers in combination with standard therapy," said Jakob Dupont, MD, OncoMed's Chief Medical Officer. "We appreciate the FDA's prompt response to our submission and their acceptance of our proposed amendments to the trial protocols."
OncoMed submitted a substantial clinical safety and efficacy data package for ipafricept along with revised study protocols to the FDA's Division of Oncology Products 1, which resulted in the removal of the partial clinical hold. The amendments for the Phase 1b combination trials include modified dosing regimens, risk mitigation measures, such as increased monitoring and bone protection strategies, and modified enrollment criteria.
"We expect enrollment in our first-in-class Wnt pathway programs, ipafricept and vantictumab, to be back underway soon," said Paul J. Hastings, Chairman and Chief Executive Officer of OncoMed. "The Wnt pathway represents a highly promising target for disrupting cancer stem cell activity and inducing tumor differentiation. As we advance ipafricept and vantictumab through clinical studies in combination with standard of care, we expect to generate key data from these Phase 1b studies that will support a potential opt-in by our partner Bayer as well as late-stage clinical development."
On June 13, 2014, OncoMed announced its decision to voluntarily halt enrollment in its Phase 1 vantictumab and ipafricept Wnt pathway programs as a precautionary measure based on reported incidents (13% and 5%, respectively) of mild-to-moderate bone adverse events. The FDA concurred with the company's decision and placed the studies on partial clinical hold, allowing for the continued dosing of patients who demonstrated benefit without significant drug-related adverse effects. The FDA removed the partial clinical hold on both programs based on data and amended study protocols submitted by OncoMed.
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