XGene Pharm. : NDA application of XG005 will follow a 505(b)(2) regulatory pathway bosed on FDA’s feedback

April 22, 2020

Xgene Pharmaceutical Inc., a clinical development-stage biopharmaceutical company, today announced that it recently held a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) to discuss the regulatory pathway for the development of XG005, a drug conjugate of naproxen and pregabalin for the management of acute pain. The company has previously completed two phases 1 clinical studies in Australia.


“Following this informative meeting with the FDA, we confirm the initial IND for XG005 oral will not require any additional nonclinical or clinical data to support a Phase 2/3 study, which will serve as one of the two pivotal studies for new drug registration with FDA. This enables us to enter the clinic study promptly with a fast-track development path to market, which is consistent with our platform of repurposing or rediscovering high-impact prescription medications for unmet or underserved needs in pain patients. We are on track to evaluate XG005 in postoperative pain for bunionectomy surgery patients in the fourth quarter of 2020.” said Gene Hsu, Ph.D., President, and CEO of Xgene.


“Utilizing the multimodal analgesia, XG005 potentially provides maximum pain relief with reduced adverse events and opioid use. The development of XG005 will be partly based on the available information on naproxen and Lyrica; therefore, the New Drug Application (NDA) application of XG005 will follow a 505(b)(2) regulatory pathway based on FDA’s feedback,” noted Dr. Gene Hsu.


The 505(b)(2) pathway allows FDA to rely on previous findings of safety and effectiveness for Reference Listed Drugs (RLDs). XG005, a prodrug-like New Chemical Entity (NCE), has been shown to be stable in the gastrointestinal (GI) tract but cleaved rapidly upon absorption by esterase to release naproxen and pregabalin. In the nonclinical studies in several species, XG005 showed superior GI safety when compared to the equivalent doses of naproxen. The results from Phase 1 studies in healthy subjects also suggest that XG005 produced less Central Nervous System (CNS)-related adverse events compared to the similar doses of Lyrica.


“We are pleased that the FDA recommended that we are only required to carry out ‘two adequate, well-controlled trials’, i.e., one Phase 2b study plus one Phase 3 study, to show the superiority of XG005 over naproxen and its contribution to Lyrica, for the NDA submission!” said Dr. Gene Hsu. “We look forward to working with the FDA to bring this much-needed treatment option to patients who suffer from pain as rapidly as possible.”


Dr. Hsu added, “XG005 got a lot of potentials, a topical XG005 formulation Phase 1 trial (SAD+MAD) in Australia has been kicked off in late 2019, and we are planning to evaluation XG005 oral on chronic pain applications, such as chemotherapy-induced neuropathic pain and low back pain, in Greater China area in 2021!”


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