Arena Pharmaceutical’s (ARNA) presentation outlined their four products, however, unsurprisingly
the main focus was on etrasimod and olorinab. They began the presentation outlining their bestin-class S1P receptor modulator Etrasimod for the treatment of ulcerative colitis (UC) and Chron’s
disease (CD). Officials claimed that there is a $3-4b market opportunity in UC and CD with
etrasimod. They also pointed out that although some think this is an already crowded market it is
estimated to be worth $23b in 2026 as the prevalence of the disease is continuously increasing.
The CDC NHIS household survey indicate that prevalence could reach 3.1m in the EU.
Additionally, officials explained that only 40% of responders on biologics achieve remission at
1year. Etrasimod recently released positive data from a Phase II OASIS open-label extension
study, which demonstrated that 39% of patients achieved long-term clinical remission at both 12
and 46 weeks. Arena further summarised recently released data, which shows that etrasimod has
rapid onset and offset action, competitive efficacy in UC and demonstrated a consistent
reduction in lymphocytes with an improved clinical response. They explained that etrasimod’s
highly selective properties enable it to have a good safety and tolerability profile with no SAEs
and most significantly there were no cases of sinoatrial arrest, which has been observed in
competing compounds. Officials also highlighted the response of 100 GI physicians in a
quantitative conjoint study, which indicated that etrasimod was likely to be preferred in the
future compared to JAK inhibitors and ozanimod. Arena stated that a Phase III UC study and
Phase II/III CD study will be initiated in 2019. They said the Phase III study, which is an expedited
trial design, aims to drive rapid enrollment through patient referrals and a high-touch
engagement using their internal field-based team.
Arena then switched its focus on exploring etrasimod for atopic dermatitis, which has a
prevalence of 22m in the US. They said that there is a severe impact on quality of life with 86% of
patients not satisfied with current treatment options. Officials reiterated that early clinical results
were positive in reducing wounds caused by pyoderma gangrenosum. A Phase II trial is expected
to initiate in 2019.
In addition, officials highlighted old data from olorinab for treatment of IBS and IBD. They noted
that olorinab was a non-opioid that could address GI pain, which is a current unmet need. Arena
summarised successful results from Phase IIa, which showed that olorinab significantly reduced
abdominal pain over 8 weeks in patients with Chron’s disease. They stated that olorinab was a
$1-3b opportunity and confirmed plans to initiate Phase IIb IBS and IBD studies in 2019.
Officials very briefly mentioned ralinepag, which is a selective prostacyclin receptor agonist for
pulmonary arterial hypertension. They highlighted their global license agreement with United
Therapeutics who will receive exclusive worldwide rights. This strengthens their strategic position
to advance etrasimod and olorinab.
Arena concluded the presentation with a summary of APD418 for decompensated heart failure.
They confirmed that this therapy improved cardiac function without any hemodynamic changes
in animals, which is an advantage over other inotrope therapies such as Dobutamine. Officials
stated that they are preparing an IND submission for 2019.
the main focus was on etrasimod and olorinab. They began the presentation outlining their bestin-class S1P receptor modulator Etrasimod for the treatment of ulcerative colitis (UC) and Chron’s
disease (CD). Officials claimed that there is a $3-4b market opportunity in UC and CD with
etrasimod. They also pointed out that although some think this is an already crowded market it is
estimated to be worth $23b in 2026 as the prevalence of the disease is continuously increasing.
The CDC NHIS household survey indicate that prevalence could reach 3.1m in the EU.
Additionally, officials explained that only 40% of responders on biologics achieve remission at
1year. Etrasimod recently released positive data from a Phase II OASIS open-label extension
study, which demonstrated that 39% of patients achieved long-term clinical remission at both 12
and 46 weeks. Arena further summarised recently released data, which shows that etrasimod has
rapid onset and offset action, competitive efficacy in UC and demonstrated a consistent
reduction in lymphocytes with an improved clinical response. They explained that etrasimod’s
highly selective properties enable it to have a good safety and tolerability profile with no SAEs
and most significantly there were no cases of sinoatrial arrest, which has been observed in
competing compounds. Officials also highlighted the response of 100 GI physicians in a
quantitative conjoint study, which indicated that etrasimod was likely to be preferred in the
future compared to JAK inhibitors and ozanimod. Arena stated that a Phase III UC study and
Phase II/III CD study will be initiated in 2019. They said the Phase III study, which is an expedited
trial design, aims to drive rapid enrollment through patient referrals and a high-touch
engagement using their internal field-based team.
Arena then switched its focus on exploring etrasimod for atopic dermatitis, which has a
prevalence of 22m in the US. They said that there is a severe impact on quality of life with 86% of
patients not satisfied with current treatment options. Officials reiterated that early clinical results
were positive in reducing wounds caused by pyoderma gangrenosum. A Phase II trial is expected
to initiate in 2019.
In addition, officials highlighted old data from olorinab for treatment of IBS and IBD. They noted
that olorinab was a non-opioid that could address GI pain, which is a current unmet need. Arena
summarised successful results from Phase IIa, which showed that olorinab significantly reduced
abdominal pain over 8 weeks in patients with Chron’s disease. They stated that olorinab was a
$1-3b opportunity and confirmed plans to initiate Phase IIb IBS and IBD studies in 2019.
Officials very briefly mentioned ralinepag, which is a selective prostacyclin receptor agonist for
pulmonary arterial hypertension. They highlighted their global license agreement with United
Therapeutics who will receive exclusive worldwide rights. This strengthens their strategic position
to advance etrasimod and olorinab.
Arena concluded the presentation with a summary of APD418 for decompensated heart failure.
They confirmed that this therapy improved cardiac function without any hemodynamic changes
in animals, which is an advantage over other inotrope therapies such as Dobutamine. Officials
stated that they are preparing an IND submission for 2019.
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