Home Interviews Celebrating IND approval Abliva eyes next step with KL1333

Celebrating IND approval Abliva eyes next step with KL1333

Abliva celebrates FDA IND approval

Celebrating IND approval Abliva eyes next step with KL1333

7 March, 2022

The reporting season is in full swing and Swedish biotech Abliva recently published their fourth quarter results for 2021. Looking at the activities in the last quarter, the company focused on lead candidate KL1333 as it took a pivotal step towards the planned phase II/III-study by obtaining Investigational New Drug-approval from the FDA. BioStock spoke to CEO Ellen Donnelly about the past quarter and what lies ahead.

With two candidates aimed at the primary mitochondrial disease space, Abliva aims to improve the situation for a group of patients that today largely lack effective treatments. KL1333 is the company’s latest-stage asset and is being developed to treat a set of adult mitochondrial disorders. Abliva’s second mitochondrial disease candidate, NV354, is aimed at the treatment of Leigh syndrome.

IND-approval for KL1333

The most important milestone achieved during the fourth quarter was undoubtedly the FDA’s approval of the Investigational New Drug (IND) application for KL1333. The decision by the US regulatory authority enables Abliva to initiate the registrational phase II/III study in the United States.

As CEO Ellen Donnelly underlines in her comment in the report, the IND-approval is one of the most significant milestones the company has achieved to date. Not only did it mean that the data package collected on KL1333 underwent the most thorough review by experts thus far but Abliva also received valuable feedback on the upcoming study design from the FDA. This feedback will now be incorporated to strengthen the study protocol for upcoming applications in other countries.

The CEO-comment also contained another piece of news related to the KL1333-project. Namely that towards the end of 2022 Abliva travelled to Seoul to meet with its partner in the KL1333-project, Yungjiun Pharm with the aim of strengthening the collaboration between the two companies.

Laying the foundation

In addition to the regulatory advancements in the KL1333-project, the fourth quarter also saw Abliva making strides when it comes to networking and raising the company’s profile. In her CEO statement, Donnelly underlines the importance of these activities and stresses the value that Abliva places on an extensive network of patient organisations, medical professionals, investors and collaborators.

During the final stages of 2021 the company focused on extending its network of physicians and clinical sites. This lays the foundation for selecting clinical sites for the upcoming phase II/III-study with KL1333 as the company expects to commence patient recruitment during 2022.

Capital raise and share price

On the financial side of things, in December Abliva announced the intention to carry out a directed issue of convertible bonds worth 26 MSEK in order to finance the development of KL1333 and provide bridge financing. The issue was approved by Abliva’s shareholders in January and is led by Abliva’s largest shareholder Hadean Ventures through its two funds Hadean Capital I AS and HVentures Capital I AB. Read more about the directed issue here.

Looking at Abliva’s share price during the fourth quarter, the market reacted positively to the news of the IND-approval. However, overall the stock was unable to resist the generally turbulent market and so far this year the stock is down by approximately 30 per cent.

CEO comments

BioStock contacted CEO Ellen Donnelly to find out more about Abliva’s fourth quarter and what comes next for the company.

Ellen Donnelly, CEO Abliva
Ellen Donnelly, CEO Abliva

Ellen, in your report you describe the meeting with Yungjin Pharm as productive. What more can you tell us about the meeting and its outcome?

– Yungjin and Abliva have worked closely together on the development of KL1333 since our in-licensing of the compound in 2017, but our meetings have largely been held via zoom due to the distance and the ongoing pandemic. In late fall it appeared that covid rates may be on the decline so we took advantage of the brief travel opening to go visit the Yungjin team in Seoul, South Korea.

– The visit was well timed as we had just received the IND approval and thus had a reason to celebrate together during our visit. During the three day meeting we went through the Phase Ia/b study data, reviewed the plans for the Phase II/III registrational study, and talked about opportunities to maximize the value of KL1333 and expand our collaboration. We are looking forward to hosting the Yungjin team in Sweden at the next opportunity.

You are in the process of selecting clinical sites for the KL1333-study, what does this work entail?

– Selecting sites for a clinical study is one of the most critical activities during study startup. During this process we are looking for sites that have great relationships with patients as their role is to identify and recruit patients for our study and then keep them engaged and motivated during the 12 month journey.

– It is important that they have access to a large number of mitochondrial disease patients and have the internal resources available to work on our study. We focus on sites with experience running clinical studies as they understand the regulatory, ethics and operational requirements that must be followed to ensure our study is run in accordance with good clinical practice (GCP) and all other guidelines.

– Finally, these sites will be our partners for the duration of the study so we are looking for sites that are excited about KL1333 and its potential to treat patients with mitochondrial diseases.

– The good news is that primary mitochondrial diseases are being recognized and diagnosed more frequently now, and patients are often managed and tracked by ‘centers of excellence’ focused on the treatment of these debilitating diseases. So in our work identifying sites we have been pleased to find many expert centers who are excited to partner with us in our effort to evaluate KL1333 as a treatment for mitochondrial disease patients.

You have received IND-approval to start the study in the US. In the report you mention future submissions to other countries. How far have you come in this process and what countries are you looking at?

– The process to identify and select countries is done in parallel to the selection of sites. Once we have selected all of our sites we will start submissions to the individual countries’ regulatory authorities and ethics review committeees. This process is expected to occur on a rolling basis throughout 2022.

When do you expect to be able to announce that the first patient has been included in the phase II/III study with KL1333?

– There are a number of factors in play that will influence the start of our Phase II/III study and the team is doing everything we can to prioritize the activities that drive the timeline. We are also challenged by the fact that a number of the activities may take a long time (e.g. the regulatory review process) and are largely outside of our control. For these reasons we are unable to provide a firm goal for study start at this time.

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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