This morning Aldeyra released topline data for their Phase 3 candidate reproxalap in allergic conjunctivitis. The company showed statistical significance in both primary and secondary endpoints
Primary Endpoint: Ocular itch score are under the curve
Relative to patients treated with vehicle, patients on the 0.25% and 0.5% reproxalap arm demonstrated statistically significant reduction in ocular itching (p < 0.0001 and p = 0.0025, respectively), as assessed by area under the ocular itch score curve.
Secondary Endpoint: Two point responder comparison
Two-point responder rates for 0.25% and 0.5% reproxalap were statistically greater than that of vehicle-treated patients (p = 0.0005 and p = 0.0169, respectively). Both concentrations of reproxalap showed anti-inflammatory effects that confirm the clinical relevance of reproxalap.
Additionally, the company showed that ~50% of patients in the 0.25% dose got a complete resolution of ocular itch (p=0.0006).
What does this all mean?
Overall, ALDX top-line data looked good. Statistical significance was shown across the board.
A positive AC readout positions ALDX’s candidate reproxalap well in the much larger dry eye indication. The Company is expected to advance 0.25% dose of reproxalap into a second Phase 3 for AC in an environmental exposure setting. This 0.25% does is also being dosed in DED, which will have Phase 3 initiation in 1H 2019. ALDX management is hopeful that reproxalap can be the first approved drug for AC/DED.
Financed to Fund 5 Phase 3 Programs
ALDX also announced a $60M term loan this morning. With an estimated $80M in cash balance and $60M term loan, the company has a $140M balance to fund their 5 Phase 3 programs. The next catalysts will likely be full AC dataset and readouts for non-infectious anterior uveitis and Sjogren Larsson in second half of the year.
At a ~$220M enterprise value, ALDX presents a good long term hold. The company is well financed and has catalysts in the next 12 month. We think the big opportunity for ALDX lies in DED. With that said, we will be taking profits and looking to revisit closer to DED data readouts in 2020.
One or more of PropThink's contributors are LONG ALDX will sell position within the following 48 hours.
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