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As Abliva prepares for its next steps in the clinical development of KL1333, the company has received good news from FDA. At a pre-Investigational New Drug meeting, FDA presented positive feedback to Abliva’s plans for continuation with the project aimed at developing a new treatment of primary mitochondrial diseases. 

In April, Abliva raised substantial amounts of capital for continuing its clinical projects. After raising 54 MSEK in a rights, after costs, issue mainly aimed at developing its main project, KL1333, the company raised another 20 MSEK in a direct share issue to a heavy weight on the Nordic life science scene – Hadean Ventures – who motivated the investment with a strong confidence in the KL1333 project. Read more.

KL1333 project plan receives ok from FDA

Abliva’s KL1333 project is developed as a treatment for primary mitochondrial disease (PMD). More specifically, the candidate, which has already obtained orphan drug status in both the US and Europe, will target patients with genetically confirmed MIDD-MELAS or KSS-CPEO spectrum disorders with multi-organ systemic symptoms.

The next step is to initiate the last part of an ongoing phase Ia/b study where patients will be dosed with KL1333 for the first time. Meanwhile, the company has already sent the necessary documentation to the FDA to move further with the project’s development plan, which includes a clinical efficacy study. Today, Abliva announced that they have received positive feedback from the FDA regarding such documentation at a pre-Investigational New Drug (pre-IND) meeting.

This also means that Abliva’s proposed clinical efficacy study will include evaluation of efficacy with regard to patient reported outcomes, as well as biomarkers of pharmacodynamic response.

Magnus Hansson, CMO Abliva

Abliva comments

Naturally, Abliva is happy about the feedback, and CMO Magnus Hansson commented in a press release: and

This is important feedback, for our KL1333 clinical program. It is also reassuring that it is aligned with the external expert input we have received and our internal plans. The next steps in the regulatory process are the submission and approval of an IND that will enable initiation and conduct of a clinical efficacy study with KL1333 in the US, and starting a similar dialogue with European regulators.

CEO Erik Kinnman filled in:

Erik Kinnman, CEO Abliva

The positive feedback from the FDA validates the preclinical, product development, and clinical documentation to date. Also, it is an additional step forwards in our efforts to deliver a needed new treatment to PMD patients.

The company plans to begin a phase II study with KL1333 in 2021, and the positive feedback from the FDA is a big step in the right direction.

 

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

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