Medicine company NeuroVive Pharmaceutical AB (Nasdaq Stockholm:NVP) (OTCQX:NEVPF) reported on Wednesday the receipt of the Orphan Drug Designation from the US FDA Office of Orphan Products Development for KL1333 for treatment of inherited mitochondrial respiratory chain diseases (MRCD).

KL1333 has reportedly been developed by the South Korean pharmaceutical company Yungjin Pharm.

In conjunction, NeuroVive was granted exclusive rights from Yungjin Pharm to develop and commercialise KL1333 globally, except in Korea and Japan.The companies will develop KL1333 within their respective territories collaborating closely on an international level to utilise possibilities for synergies.

The first clinical phase I study has recently recruited its last healthy volunteer and results are expected by June. NeuroVive plans to start the next clinical phase I multiple ascending dose study in the second half of 2018. The pre-clinical models been shown to increase mitochondrial aerobic energy production, while limiting the accumulation of lactate, counteracting the formation of free radicals and lead to other long-term positive effects on energy metabolism.

KL1333 is a potent modulator of the cellular levels of NAD+, a central coenzyme in the cell's energy metabolism. Its mode of action is complementary to that of NVP015, which is intended to alleviate acute episodes of energy crises in genetic mitochondrial disorders with dysfunction in respiratory complex I and to NVP025, intended to protect the mitochondria in skeletal muscle from dysfunctional calcium handling and consequential muscle wasting, added the company.

This US FDA's ODD will give the KL1333 programme extra access to regulatory and scientific advice and interactions with the FDA and may enable a focused development programme and speedy approval process. ODD provides market exclusivity for seven years within US for NeuroVive´s KL1333.