Vuosikertomuksen toimitusjohtajan kommenteissa Vuolanto on taas korostanut tutkimuksen laajentamista muihin hermorappeumasairauksiin tästä vuodesta alkaen, sekä biomarkkeritutkimuksen edistymistä.
Lisäksi alleviivataan Faasi 1a:n tuloksia rahoitusneuvotteluaseman paranemiseen, ja että 2024 pistetään kunnolla panoksia neuvottelujen edistämiseen. Tämä kuulostaisi kyllä siltä, että sopimusta haetaan jo, vaikka Faasi 1b:n tulokset eivät olisi vielä tulleet. (boldaukset omia)
CEO’s statement
In 2023, we conducted the first-in-human clinical
trial with our HER-096 drug candidate. The results
of the study were in line with our expectations: in
addition to a good safety profile, we showed that
HER-096 efficiently penetrates through the blood-
brain barrier into the central nervous system
in humans. HER-096 can therefore be dosed
as a patient-friendly injection under the skin.
This provides an excellent base for continuing
both the partnership discussions and further
development of HER-096.
Herantis had one main goal for 2023: to conduct the Phase 1a
clinical trial of HER-096. Altogether 64 healthy volunteers were
recruited for the study, who were administered one subcuta-
neous dose of HER-096 drug candidate to determine safety and
tolerability. Furthermore, our goal was to study the behavior of
HER-096 in humans and to demonstrate that HER-096 passes
through the blood-brain barrier into the cerebrospinal fluid. We
are very excited that the study met all its goals!
We further strengthened the preclinical evidence of the effects
of HER-096 in Parkinson’s disease models. We have shown
that HER-096 modifies the function of the target mechanism
in neurons, and the changes lead to an improvement in the
function of neurons, an increase in the secretion of the neuro-
transmitter dopamine, and therefore an improvement in motor
symptoms. Therefore, we believe HER-096 has the potential to
become a disease modifying treatment for Parkinson’s disease.
In the future, our goal is to expand preclinical studies to
other neurodegenerative diseases as well. We have also
made progress in our biomarker studies, which are carried
out thanks to project funding from the European Innovation
Council Accelerator Program (EICA). The EICA project started
in May 2023 and will continue until 2025. In connection with
the project, we signed an agreement with the EIC Fund for
capital investments of 15 million euros. EIC Fund participates
in future capital investment rounds with a maximum of 1/3
of the shares issued. EIC Fund made its first investment of
around 1.5 million euros in December, when we carried out a
directed share issue of 4.5 million euros to selected new and
existing shareholders.
The results of the Phase 1a clinical trial were in line with our
expectations and the strengthening of the preclinical evidence
have improved our position. Our aim is to find a global phar-
maceutical company as our partner for clinical development
and commercialization of HER-096. In 2024, we will focus all
our energy on speeding up the partnership negotiations. For
now, however, it is difficult to predict when a possible partner-
ship agreement will be concluded.
I would like to thank our highly professional team, our part-
ners, our shareholders, and especially the healthy volun-
teers who participated in the HER-096 clinical trial for a very
successful year 2023!
Antti Vuolanto
CEO of Herantis Pharma Plc
Ylläolevaan rahoitusneuvotteluaktiviteettiin liittyen nostetaan myös muutama päivä sitten tullut tiedote, jos jollain mennyt ohi. Alkuvuodesta ollut paljon aktiviteettia osallistumisesta monenlaisiin eri tilaisuuksiin, ja sama meno näyttää jatkuvan.
En tiedä mikä aivopieru käynyt. Muistaakseni Vuolanto on jossain maininnut Faasi 1b:n tulokset tulisivat 2025 alkupuolella. Voi toki olla, että ensimmäisiä tuloksi tulisi jo tämän vuoden puolella ainakin turvallisuuden osalta, ehkä biomarkkeridataa joudutaan analysoimaan pidempää?
