Lumosa Announces FDA Acceptance of IND Application for LT1001, an Extended-Release Analgesic Injection - Lumosa to Initiate the Bridging Study in the US

TAIPEI,Dec. 3,2019 -- Opioid misuse,addiction,and overdoses have caused significant social and economic burdens leading to the opioid crisis. LT1001 (brand name Naldebain®) is a prodrug of nalbuphine,an abuse-free analgesic that has been marketed worldwide for decades. Naldebain® is developed by Lumosa Therapeutics ("Lumosa;" 6535.TWO) as the world's first extended-release analgesic injection for the relief of moderate/severe post-operative pain for 7 days without the side effects associated with opioids. Naldebain® was approved by the Taiwan Food and Drug Administration (TFDA) in March 2017. A considerable amount of clinical data and use experience have accumulated since product launch. With confirmed safety and efficacy data of over 20 thousand users,Naldebain® is an attractive pain management solution for the opioid crisis.

To facilitate licensing negotiation and shorten the development time to market,Lumosa obtained consent from the US FDA in 2017 to allow the development of LT1001 through 505(b)(2) pathway,a development process with reduced number of human clinical trials required for the drug approval. The US FDA has recently accepted the IND (investigational new drug) application of the comparative bioavailability study. Lumosa will initiate the study shortly to bridge the clinical data of LT1001 and nalbuphine in the US. The trial will fulfill the pre-market confirmatory trial required under the 505(b)(2) guideline. Subsequently,a confirmatory trial according to the 505(b)(2) pathway will be conducted before the submission of a new drug application (NDA) to the US FDA for marketing authorization approval.

Lumosa anticipates the enrollment of the pharmacokinetic study to be completed in the first half of 2020. In the meantime,licensing negotiation with potential US partners will take place in order to expedite the time to market for LT1001 and to compete in the US analgesics market. The completion of the bridging study would most likely speed up the licensing process. Lumosa has obtained patent protection up to 2035 in the US,with the patents in European Union,China,Japan and other major pharmaceutical markets currently under review by the respective authorities.

The US prescription opioid sales volume in 2015 was calculated to be US$ 7.1 billion using the information listed in the white paper "FDA Analysis of Long-Term Trends in Opioid Analgesic Products: Quantity,Sales,and Price Trends," published in 2018 by the US FDA. The advantages and competitiveness of Naldebain® have drawn the interests of numerous prospective partners. Lumosa is actively engaged in licensing negotiations in various regions worldwide.

About Lumosa

Lumosa Therapeutics,a public traded biotech company in Taiwan (6535.TWO),is a company with strong expertise in late-translational research and clinical development for new drugs. The company in-licenses early-stage candidates and maximizes project value through precise regulatory and clinical strategies,creating sustainable and long-term profit through the company's international networking. Several projects with high unmet medical need at various development stages are available for collaborations; these include LT1001 for pain management,LT3001 for acute ischemic stroke,LT5001 for uremic pruritus,and LT2003 for solid tumor.

About LT1001

LT1001 (brand name Naldebain®) is the world's first extended-release analgesic injection containing dinalbuphine sebacate,a prodrug of nalbuphine,in an oil-based formulation intended for sustained release of the drug. Nalbuphine is a κ-agonist / partial μ-antagonist analgesic with an analgesic effect comparable to that of morphine,yet it has a ceiling effect on respiratory depression. LT1001 was designed to take advantages of nalbuphine's safety profile and overcome the disadvantage of nalbupine's relatively short half-life of 2 to 6 hours to provide week-long analgesic relief. LT1001 was approved by Taiwan FDA in March 2017 as Naldebain®. NDAs for Switzerland and Singapore were submitted. Lumosa will initiate a comparative bioavailability study in the US under the 505(b)(2) guideline.

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