Abliva decides on a SEK200m financing to fund Phase 2/3 study
The financing (around €19m) shall fully fund the commencement of a potentially pivotal/registrational Phase 2/3 study for KL1333 and its progression to the outcome of a key interim analysis.
Swedish Abliva is focussing on mitochondrial medicine, developing therapeutics for primary mitochondrial diseases, orphan indications of high unmet medical need. KL1333 restores the balance of the coenzymes NAD+ and NADH, creating new mitochondria and improved energy levels. KL1333 has completed a number of key Phase 1 studies to prepare the asset for registrational Phase 2/3 study start in 2022. According to Abliva KL1333 is protected by both a composition of matter patent as well as Orphan Drug Designation (ODD) in the U.S. and in Europe. The commercial opportunity is estimated exceeding $1bn/year in annual sales. The clinical trial was originally planned to start at the end of 2021, but was delayed.
KL1333 has been developed by the South Korean pharmaceutical company Yungjin Pharm and has in pre-clinical models been shown to increase mitochondrial aerobic energy production, NeuroVive was 2017 granted exclusive rights from Yungjin Pharm to develop and commercialise KL1333 globally, except in Korea and Japan where Yungjin Pharm retains its exclusive rights. In 2020 NeuroVive changed its name to Abliva.
Mitochondria function as the powerhouses of our cells has become an area of increasing focus for the pharmaceutical industry as there are currently no effective treatment options for patients. Primary mitochondrial diseases are rare orphan diseases where the energy metabolism in the cells is impaired, causing deterioration that leads to multifaceted disorders and great suffering for patients. The symptoms worsen over time and, in many cases, the diseases lead to premature mortality.
The fundraise will also add new sharholders to Abliva including IP Group plc. IP Group is a FTSE250 London-based science & technology investor with particular expertise in the global biotechnology industry and – i the words of Abliva – "a track-record of identifying undervalued therapeutic programmes and helping these attain key developmental and value-accreting milestones". Existing specialist life science venture capital investor and the Companys largest shareholder, Hadean Ventures, is also participating with a new investment, in addition to the conversion of its outstanding convertible loans. OPF, a Norweigan institutional investor, will also join the round with other international institutional investors.
