-- Company Preparing to Initiate Phase 3 Program in 2016 --
-- Naloxone PRT Uniquely Targets the Cause of OIC in the Gastrointestinal Tract; Minimizes Undesirable Systemic Adverse Effects --
BASEL, Switzerland, Feb. 25, 2016 (GLOBE NEWSWIRE) -- Algobate AG, a Develco Group company, today announced that it has successfully completed an End-of-Phase 2/Pre-Phase 3 meeting with the U.S. Food and Drug Administration (FDA) on its prolonged-release, once daily, oral tablet formulation of naloxone (NLX PRT) for the treatment of Opioid Induced Constipation (OIC) in patients with chronic non-cancer pain. At the meeting, which took place late last year, there was general agreement on key elements of a Naloxone PRT Phase 3 clinical program including the design of the two proposed Phase 3 clinical trials.
Based on interactions with the FDA, Algobate believes that the results of these Phase 3 trials, together with other data in the NLX PRT development program and relevant reference products, could form the basis of a New Drug Application (NDA) via a 505(b)(2) pathway allowing for important efficiencies. As a result, the Company is preparing to initiate a Phase 3 clinical development program in 2016. In parallel with preparing for the start of the Phase 3 program, Algobate is evaluating strategic partnerships to finance the development and marketing of NLX PRT in the U.S.
“We are very pleased with the outcome of our Pre-Phase 3 meeting with the FDA and the clear guidance for Naloxone PRT’s remaining OIC registration program,” said Michael Motz, Ph.D., Chief Executive Officer of Algobate AG. “We are poised to initiate the Phase 3 studies this year in the hopes of bringing Naloxone PRT to patients with chronic non-cancer pain and OIC as soon as possible. Our goal is to have the first U.S. approved drug that directly targets the etiology of OIC through activity localized to the gut, thereby minimizing undesirable systemic adverse effects.”
According to Mathias Scheer, Ph.D., Chairman of the Board of Algobate AG, “Given Algobate's and Develco's clinical and regulatory experience executing their development program for Naloxone PRT in Europe, we are confident in our likelihood for success related to the conduct of the Phase 3 clinical program and an efficient path to NDA filing. Depending on patient enrollment and retention, Phase 3 clinical results could be expected as early as the second half of 2018, allowing for a potential NDA filing in 2019.”
About Opioid-Induced Constipation
There are over 30 million patients in the U.S. who receive long-term opioid treatment for the management of chronic pain. The use of opioid analgesics is often a component of multimodal care for managing chronic pain. Opioid-induced constipation, caused by binding of opioid agonists to opioid receptors within the gastrointestinal tract, is the most frequent and often most burdensome symptom associated with chronic opioid therapy. Unlike other opioid-related adverse effects, patients do not develop tolerance to OIC, thus requiring long-term treatment.
About Naloxone PRT
Naloxone PRT, the only prolonged-released peripherally-acting mu opioid receptor antagonist (PAMORA) in development, utilizes Develco’s proprietary oral drug delivery technology, which consists of a tablet with sustained release pellets in a hydrogel given once daily and delivering naloxone locally to the gastrointestinal tract. Naloxone, when administered orally, has a short half-life and high first pass metabolism and results in very low systemic exposure. Its pharmacologic effect on reversing OIC is driven by local residence within the gastrointestinal tract, lowering the risk of systemic adverse effects. Naloxone, though widely used for the treatment of opioid overdose, via intravenous or intranasal administration, is currently not available in an oral formulation in the U.S. for the treatment of OIC. Naloxone PRT is an attractive option for development given its potential for differentiation, efficient U.S. development path, and its favorable benefit-to-risk profile demonstrated in controlled European OIC clinical studies.
About Algobate AG
Algobate AG is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies, initially developed by its parent company Develco Pharma AG, to develop and commercialize in partnerships with third parties, new applications of proven therapeutics. Algobate is focusing on developing products to meet unmet patient needs in the areas of pain management and pain related side effects such as Opioid Induced Constipation. Algobate´s parent company Develco Pharma Schweiz AG has a broad portfolio using its proprietary delivery technology for generic products globally. Algobate’s headquarters are located in Stansstad, Switzerland, with offices in Pratteln, near Basel, Switzerland. For more information, visit www.algobate.ch and www.develco.ch.