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I slutet av januari meddelade Abliva att dr Ellen K. Donnelly, en branschveteran med viktig erfarenhet inom utveckling av behandlingar mot sällsynta sjukdomar har utsetts till ny vd. Dåvarande vd Erik Kinnman lämnade i början av  februari över rollen som vd i bolaget vars fokus ligger på sällsynta mitokondriella sjukdomar. BioStock fick chansen att prata med Donnelly om hennes bakgrund, hur hon ser på Ablivas potential och vad som väntar härnäst för bolaget.

Biofarmabolaget Abliva utvecklar läkemedel mot sällsynta primära mitokondriella sjukdomar. Mitokondrierna skapar den energi som krävs för att människor ska fungera optimalt, och hos patienter som lider av en primär mitokondriell sjukdom fungerar inte den energiskapande processen i mitokondrierna som den ska. För de drabbade har detta allvarliga konsekvenser såsom celldöd och förlust av organfunktion, vilket gör det svårt att t.ex. röra sig och andas, och i många fall förkortas livslängden betydligt.

Två kandidater i pipelinen

Idag saknas i stor utsträckning både kunskap om och effektiva behandlingar mot dessa sjukdomar – något som Abliva vill ändra på genom utvecklingen av sin två kandidater. Huvudkandidaten KL1333, som utvecklas mot MELAS och liknande tillstånd, har redan särläkemedelsklassificering i både USA och Europa.

Just nu pågår patientstudier med KL1333 och bolaget förbereder en sammanhållen registreringsgrundande fas II/III-effektstudie som ska initieras under andra halvåret 2021. Beslutet att genomföra en sammanhållen studie bygger på en rekommendation från amerikanska FDA som i somras gav positiv feedback gällande bolagets utvecklingsplan. Även den brittiska läkemedelsmyndigheten MHRA har ställt sig positiva till Ablivas accelererade utvecklingsplan.

Ablivas andra kandidat, NV354, riktas mot Leighs syndrom och planen är att slutföra prekliniska farmakologi- och säkerhetsstudier under första halvåret 2021. Man siktar på att samtidigt producera prövningsmaterial och att ha programmet redo för kliniska studier under andra halvåret 2021.

Ny fas – ny vd

Med KL1333 på väg mot sena kliniska studier önskar Abliva att fokusera mer på kommersialiseringsaktiviter. Mot denna bakgrund har bolaget nu rekryterat dr Ellen K. Donnelly till positionen som vd. Donnelly, som är doktor i farmakologi, har bl.a. viktig erfarenhet inom utveckling av behandlingar mot sällsynta sjukdomar från sin tid som vd för svenska Modus Therapeutics.

Läs en intervju med Ablivas styrelseordförande om vd-bytet här.

BioStock fick möjligheten att tala med Donnelly om hur hon ser på sin nya roll och på Ablivas potential.

Ellen K. Donnelly, vd för Abliva

Ellen, first of all, can you tell us a bit about your academic and professional background?

– Thank you for the opportunity to speak with you! Over the past twenty years, I have spent time working, leading, and learning in both biotech companies as well as big pharmaceutical companies, across many diverse areas.  After receiving my PhD from Yale University (Pharmacology), I worked as a management consultant focused exclusively on advising clients in the healthcare industry.  From this experience, I knew I loved working with small biotechs, but I also recognised that I had a great deal to learn.

– After this, I spent almost a decade at Pfizer in positions ranging from internal consulting, portfolio and project management, neuroscience research & development, and clinical operations. When my family relocated to Stockholm in late 2016, I took the opportunity to leave Pfizer and joined Modus Therapeutics AB as CEO. I led Modus from 2017 to 2020 and then joined a healthy aging company, Juvenescence, where I was responsible for several companies as well as a division focused on Epigenetics. My heart was still in Sweden, though, and I am happy to be back leading Abliva.

What attracted you to the role as CEO of Abliva?

– I am passionate about the development of new therapies for patients with rare diseases and Abliva has a strong package – a focus on a rare disease (primary mitochondrial disease) with high commercial potential, a portfolio with differentiated, life-changing therapies and an expert team of drug developers that have the knowledge necessary to take our therapies to the market.

– When comparing Abliva to other companies in this space, it is clear that Abliva has significant, unrecognised value and I look forward to communicating our story to new and current investors as we make Abliva an internationally-recognised leader in mitochondrial medicine.

What are the most important experiences from your work in the life science sector that you take with you to Abliva and how will they benefit the company?

– I think my experiences in working on the development of rare indications – both as it relates to patient interactions, regulatory opportunities, and specialist investors – will be extremely helpful to Abliva as we move KL1333 through development to the market.

– I also think my network in the United States and my knowledge of the U.S. policies, vendors, and landscape will help us as we expand our efforts abroad.

What new perspectives do you hope to bring to Abliva and how will these affect the company’s development?

– The team at Abliva has done a remarkable job of building a world-class biotech company but it has been hard to get the company recognised outside of Sweden. I hope that the establishment of a new office in Boston will help increase the visibility of the company and move us to the next level.

– I also look forward to working with the team to increase our interactions with patient groups and physicians across the EU and in the US to ensure that the full potential of KL1333 and NV354 are recognised and that patients and physicians are excited about participating in our upcoming clinical study.

Given your experience in the rare disease space, how do you view the potential of KL1333 and NV354?

– Abliva has the ability to make a difference in the lives of thousands of patients across the world that suffer from a painful, debilitating disease called mitochondrial disease. KL1333, our lead compound in phase I, will enter a large global, registrational phase II/III study later this year and, if positive, could be on the market as soon as 2025. The data package that we have supporting the drug, from both preclinical experiments demonstrating efficacy and safety information from healthy volunteers, suggest a great deal of potential for KL1333.

– NV354 is still in the preclinical space, but we hope to get important data this year that could, if positive, support a clinical start.

– The primary assessment of efficacy will not come until the phase II/III study; however, the Abliva team is actively de-risking the development program to ensure KL1333 has the best chance of success!

What will be your first focus now that you have taken over the role as CEO?

– My primary objective is to ensure the company is optimally financed and properly valued. I will do this by communicating the Abliva story across Sweden, Europe and the U.S.; being transparent as to the strengths and opportunities of our programs, and accurately setting expectations as to what to expect from the company during this pivotal year ahead for the company.

Finally, where do you see Abliva in two years?

– With the readout of our phase I study and the launch of our new phase II/III study later this year, the future of Abliva is bright. In two years, I anticipate that Abliva will have transitioned into a global late-stage biopharmaceutical company actively preparing for commercialisation of KL1333 as we await the readout of our pivotal phase II/III trial.

– In addition to our lead late-stage asset, we aim to have a strong portfolio of clinical stage compounds focused on a diverse range of mitochondrial diseases. With the successful achievement of the milestones ahead, I would expect that we will have attracted additional investment and solidified the confidence of our current shareholder base.

 

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